An Open-label Study of GBT021601 in 8 to 10 healthy male or female participants to evaluate the absorption, distribution, metabolism, and excretion (ADME) of GBT021601.
This is an open-label Study administering GBT021601 as a single oral dose of 200 mg in healthy participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
9
Single oral dose of 200 mg GBT021601, containing \~74 kBq (\~2 µCi) of \[14C\]-GBT021601
ICON Early Phase Clinic, LLC
Groningen, Netherlands
GBT021601 Concentration in Whole Blood and Plasma at Predose
Time frame: Predose (within 60 minutes prior to GBT021601 dosing)
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at Predose
Data reported in microgram equivalent per milliliter (mcgEq/mL).
Time frame: Predose (within 60 minutes prior to 14C-GBT021601 dosing)
GBT021601 Concentration in Whole Blood and Plasma at 0.25 Hours
Time frame: 0.25 hours post dosing on Day 1
14C-GBT021601 Total Radioactivity Concentrations in Whole Blood and Plasma at 0.25 Hours
Time frame: 0.25 hours post dosing on Day 1
GBT021601 Concentration in Whole Blood and Plasma at 0.50 Hours
Time frame: 0.50 hours post dosing on Day 1
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 0.50 Hours
Time frame: 0.50 hours post dosing on Day 1
GBT021601 Concentration in Whole Blood and Plasma at 1 Hours
Time frame: 1 hours post dosing on Day 1
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1 Hours
Time frame: 1 hours post dosing on Day 1
GBT021601 Concentration in Whole Blood and Plasma at 2 Hours
Time frame: 2 hours post dosing on Day 1
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2 Hours
Time frame: 2 hours post dosing on Day 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GBT021601 Concentration in Whole Blood and Plasma at 3 Hours
Time frame: 3 hours post dosing on Day 1
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3 Hours
Time frame: 3 hours post dosing on Day 1
GBT021601 Concentration in Whole Blood and Plasma at 4 Hours
Time frame: 4 hours post dosing on Day 1
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4 Hours
Time frame: 4 hours post dosing on Day 1
GBT021601 Concentration in Whole Blood and Plasma at 6 Hours
Time frame: 6 hours post dosing on Day 1
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 6 Hours
Time frame: 6 hours post dosing on Day 1
GBT021601 Concentration in Whole Blood and Plasma at 8 Hours
Time frame: 8 hours post dosing on Day 1
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 8 Hours
Time frame: 8 hours post dosing on Day 1
GBT021601 Concentration in Whole Blood and Plasma at 12 Hours
Time frame: 12 hours post dosing on Day 1
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 12 Hours
Time frame: 12 hours post dosing on Day 1
GBT021601 Concentration in Whole Blood and Plasma at 24 Hours
Time frame: 24 hours post dosing on Day 1
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 24 Hours
Time frame: 24 hours post dosing on Day 1
GBT021601 Concentration in Whole Blood and Plasma at 48 Hours
Time frame: 48 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 48 Hours
Time frame: 48 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 72 Hours
Time frame: 72 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 72 Hours
Time frame: 72 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 96 Hours
Time frame: 96 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 96 Hours
Time frame: 96 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 144 Hours
Time frame: 144 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 144 Hours
Time frame: 144 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 168 Hours
Time frame: 168 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 168 Hours
Time frame: 168 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 312 Hours
Time frame: 312 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 312 Hours
Time frame: 312 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 480 Hours
Time frame: 480 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 480 Hours
Time frame: 480 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 648 Hours
Time frame: 648 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 648 Hours
Time frame: 648 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 816 Hours
Time frame: 816 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 816 Hours
Time frame: 816 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 984 Hours
Time frame: 984 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 984 Hours
Time frame: 984 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 1320 Hours
Time frame: 1320 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1320 Hours
Time frame: 1320 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 1656 Hours
Time frame: 1656 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1656 Hours
Time frame: 1656 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 1992 Hours
Time frame: 1992 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 1992 Hours
Time frame: 1992 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 2328 Hours
Time frame: 2328 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2328 Hours
Time frame: 2328 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 2664 Hours
Time frame: 2664 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 2664 Hours
Time frame: 2664 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 3240 Hours
Time frame: 3240 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3240 Hours
Time frame: 3240 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 3576 Hours
Time frame: 3576 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 3576 Hours
Time frame: 3576 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 4248 Hours
Time frame: 4248 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4248 Hours
Time frame: 4248 hours post dosing
GBT021601 Concentration in Whole Blood and Plasma at 4920 Hours
Time frame: 4920 hours post dosing
14C-GBT021601 Total Radioactivity Concentration in Whole Blood and Plasma at 4920 Hours
Time frame: 4920 hours post dosing
Cumulative Amount of [14C]-GBT021601 Total Radioactivity Excreted in Urine and Feces
Data are reported as aggregate of all scheduled time points.
Time frame: Day 1 (prior to dosing), after dosing from 0-6 hours, 6-12 hrs, 12-24 hrs postdose for urine, 24-hr intervals up to Day 29; 816 hrs , 984 hrs, 1320 hrs, 1656 hrs, 1992 hrs, 2328 hrs, 2664 hrs, 3240 hrs, 3576 hrs, 4248 hrs, and 4920 hrs post-dose
Cumulative Fraction of [14C]-GBT021601 Total Radioactivity Excreted in Urine and Feces
Data are reported as aggregate of all scheduled time points.
Time frame: Day 1 (prior to dosing), after dosing from 0-6 hours, 6-12 hrs, 12-24 hrs postdose for urine, 24-hr intervals up to Day 29; 816 hrs , 984 hrs, 1320 hrs, 1656 hrs, 1992 hrs, 2328 hrs, 2664 hrs, 3240 hrs, 3576 hrs, 4248 hrs, and 4920 hrs post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero (0) to 24 Hours (AUC0-24) of GBT021601 in Whole Blood and Plasma
Area under the plasma concentration-time curve up to 24 hours post dose. Data reported in Hour\*microgram/millimeter (h\*mcg/mL).
Time frame: Day 1 (prior to dosing) at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours
Area Under the Plasma Concentration-Time Curve From Time Zero (0) to 24 Hours (AUC0-24) of 14C-GBT021601 in Whole Blood and Plasma
Area under the plasma concentration-time curve up to 24 hours postdose. Data reported in hour\*microgram equivalent/milliliter (h\*mcgEq/mL).
Time frame: Day 1 (prior to dosing) at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours
Area Under the Concentration-Time From Time Zero to the Last Measurable Concentration (AUC0-last) of GBT021601 in Whole Blood and Plasma
Time frame: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Area Under the Concentration-Time From Time Zero to the Last Measurable Concentration (AUC0-last) of 14C-GBT021601 in Whole Blood and Plasma
Time frame: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of GBT021601 in Whole Blood and Plasma
Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf=AUC0-t+Clast/kel, where Clast is the last measurable plasma concentration.
Time frame: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of 14C-GBT021601 in Whole Blood and Plasma
Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf=AUC0-t+Clast/kel, where Clast is the last measurable plasma concentration and Kel is apparent terminal elimination rate constant.
Time frame: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Maximum Observed Concentration (Cmax) of GBT021601 in Whole Blood and Plasma
Time frame: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Maximum Observed Concentration (Cmax) of 14C-GBT021601 in Whole Blood and Plasma
Time frame: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Time to Attain Maximum Observed Concentration (Tmax) of GBT021601 in Whole Blood and Plasma
Time frame: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Time to Attain Maximum Observed Concentration (Tmax) of 14C-GBT021601 in Whole Blood and Plasma
Time frame: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Apparent Terminal Elimination Half-Life (t1/2) of GBT021601 in Whole Blood and Plasma
Apparent terminal elimination half-life, calculated as 0.693/kel where kel is Apparent terminal elimination rate constant.
Time frame: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Apparent Terminal Elimination Half-Life (t1/2) of 14C-GBT021601 in Whole Blood and Plasma
Apparent terminal elimination half-life, calculated as 0.693/kel where kel is Apparent terminal elimination rate constant.
Time frame: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Renal Clearance (CLR) of GBT021601 and 14C-GBT021601 in Urine
Renal clearance was calculated as CLR = Ae0-inf/AUC0-inf. Where Ae indicates Cumulative amount of drug excreted and AUC0-inf indicates Area under the plasma concentration-time curve from time 0 to infinity.
Time frame: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Apparent Volume of Distribution at Terminal Phase (Vz/F) of GBT021601 in Whole Blood and Plasma
Apparent volume of distribution at terminal phase, calculated as: (CL/F) Apparent total clearance, calculated as dose/AUC0-inf/Kel.
Time frame: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Apparent Volume of Distribution at Terminal Phase (Vz/F) of 14C-GBT021601 in Whole Blood and Plasma
Apparent volume of distribution at terminal phase, calculated as: (CL/F) Apparent total clearance, calculated as dose/AUC0-inf/Kel.
Time frame: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Apparent Total Clearance (CL/F) of GBT021601 in Whole Blood and Plasma
Apparent total clearance, calculated as dose/AUC0-inf.
Time frame: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Apparent Total Clearance (CL/F) of 14C-GBT021601 in Whole Blood and Plasma
Apparent total clearance, calculated as dose/AUC0-inf.
Time frame: Day 1 (prior to dosing), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 144,168, 312, 480, 648, 816, 984,1320,1656,1992, 2328, 2664, 3240, 3576, 4248 and 4920 hours post-dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 0-6 Hours
Time frame: 0-6 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 6-12 Hours
Time frame: 6-12 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 12-24 Hours
Time frame: 12-24 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 0-24 Hours
Time frame: 0-24 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 24 Hours
Time frame: 24 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 48 Hours
Time frame: 48 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 72 Hours
Time frame: 72 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 96 Hours
Time frame: 96 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 120 Hours
Time frame: 120 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 144 Hours
Time frame: 144 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 168 Hours
Time frame: 168 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 192 Hours
Time frame: 192 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 216 Hours
Time frame: 216 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 240 Hours
Time frame: 240 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 264 Hours
Time frame: 264 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 288 Hours
Time frame: 288 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 312 Hours
Time frame: 312 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 336 Hours
Time frame: 336 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 360 Hours
Time frame: 360 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 384 Hours
Time frame: 384 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 408 Hours
Time frame: 408 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 432 Hours
Time frame: 432 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 456 Hours
Time frame: 456 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 480 Hours
Time frame: 480 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 504 Hours
Time frame: 504 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 528 Hours
Time frame: 528 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 552 Hours
Time frame: 552 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 576 Hours
Time frame: 576 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 600 Hours
Time frame: 600 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 624 Hours
Time frame: 624 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 648 Hours
Time frame: 648 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 816 Hours
Time frame: 816 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 984 Hours
Time frame: 984 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1320 Hours
Time frame: 1320 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1656 Hours
Time frame: 1656 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 1992 Hours
Time frame: 1992 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 2328 Hours
Time frame: 2328 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 2664 Hours
Time frame: 2664 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 3240 Hours
Time frame: 3240 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 3576 Hours
Time frame: 3576 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 4248 Hours
Time frame: 4248 hours post dose
Distribution of 14C- GBT021601 Total Radioactivity in Urine and Feces at 4920 Hours
Time frame: 4920 hours post dose
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An Adverse event (AE) was any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. TEAEs were those which occurred (or worsened) after the dose of study drug during the on-treatment period, defined as the period after the dose of study drug and through the minimum of (Study Day 57, study discontinuation).
Time frame: From Day 1 up to maximum of Day 57
Number of Participants With Clinically Significant Laboratory Values
Blood and urine samples was collected for clinical laboratory assessments. Clinical Laboratory Values included Clinical chemistry: alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin (total, direct, and indirect), blood urea nitrogen, calcium, chloride, creatinine, gamma glutamyl transferase, glucose, lactate dehydrogenase, magnesium, phosphorus, potassium, sodium, total protein, and uric acid. Hematology: leukocytes, erythrocytes, hematocrit, Hb, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count (ie, thrombocytes), RBC count, and white blood cell count etc. Urinalysis: determination of pH and specific gravity, and presence of bilirubin, blood, glucose, ketones, nitrite, protein, leukocytes, and urobilinogen etc. Coagulation, Serology, Drug and alcohol screen and Pregnancy test. Clinical significance was judged by investigator.
Time frame: Day 1 of dosing to Day 207
Number of Participants With Clinically Significant Vital Signs Values
Systolic and diastolic blood pressure and pulse was recorded after the participant had rested for at least 5 minutes in the supine position. Body temperature and respiratory rate was also measured. Clinical significance was judged by investigator.
Time frame: Day 1 of dosing to Day 207
Number of Participants With Clinically Significant ECG Values
Standard 12-lead ECGs were performed after the participant had rested quietly for more than 5 minutes in a supine position utilizing an ECG machine that was equipped with computer-based interval measurements. The following measurement was recorded: the heart rate (of \<45 or \>100 beats per minute (BPM) , PR interval, QT interval, QT interval corrected using Fridericia's formula (QTcF) of \>450 msec for males and \>470 msec for females, and QRS duration. Any cardiac rhythm other than sinus rhythm that was interpreted by the Investigator was clinically significant.
Time frame: Day 1
Number of Participants With Clinically Significant Physical Examination Values
Physical Examination test included body weight and height. physical examination was conducted at screening. Clinical significance was judged by investigator.
Time frame: Screening (-28 Day to -2 Day, day with respect to dosing)