The purpose of this study is to evaluate the oral bioavailability of two new tablet formulations of TAK-385 (T4 Formulation B and T4 Formulation C) under fasted and fed conditions, relative the T2 Formulation tablet; and to estimate the effect of food on the pharmacokinetics (PK) of a single oral dose of the T4 Formulation B tablet and the T4 Formulation C tablet.
The drug being tested in this study is called TAK-385. In this study, two new formulations of TAK-385 are being evaluated under fasted and fed conditions, relative to a previous formulation of TAK-385, to assess its bioavailability and how it is processed by the body. This study will look at lab results of people who take TAK-385. The study will enroll approximately 54 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups (Arms). Participants in Arm 1 will receive TAK-385 T2 Formulation 120 mg tablet (80mg + 40mg tablets) under fasted conditions, TAK-385 T4 Formulation B 120 mg tablet under fasted conditions, and TAK-385 T4 Formulation B 120 mg tablet under fed conditions. Participants in Arm 2 will receive TAK-385 T2 Formulation 120 mg tablet (80mg + 40mg tablets) under fasted conditions, TAK-385 T4 Formulation C 120 mg tablet under fasted conditions, and TAK-385 T4 Formulation C 120 mg tablet under fed conditions. Participants in each arm will be randomized to receive study drug in one of 6 treatment sequences. Study medication will be administered as a single dose on Days 1, 11 and 21. There will be a 10-day washout period between each dose. This single-centre trial will be conducted in the United States. The overall time to participate in this study is 51 days. Participants will make 10 visits to the clinic, including three 4-day periods of confinement to the clinic, and will be contacted by telephone 30 days after last dose of study drug for a follow-up assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
TAK-385 T2 Formulation tablets
TAK-385 T4 Formulation B tablets
TAK-385 T4 Formulation C tablets
Unnamed facility
Tempe, Arizona, United States
Cmax: Maximum Observed Plasma Concentration for TAK-385
Time frame: Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose
AUC(0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Postdose for TAK-385
Time frame: Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385
Time frame: Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Time frame: From Day 1 to 30 days after the last dose of study drug (Up to 51 days total)
Number of Participants With Shifts From Normal at Baseline in Safety Laboratory Values in More Than 1 Participant
Participants with shifts from normal at Baseline in safety laboratory values (Clinical Chemistry, Hematology and Urinalysis) collected throughout study. Low=below normal reference range, Normal=within reference range, High=above normal reference range and Abnormal=outside of normal reference range.
Time frame: Baseline and Days 4, 10, 14, 20, 24 and 26
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Percentage of Participants With Electrocardiogram (ECG) Parameters Abnormal and Clinically Significant
A 12-lead ECG was administered. The investigator interpreted the ECG using one of the following categories: within normal limits, abnormal but not clinically significant, or abnormal and clinically significant.
Time frame: Days 1, 11, 21 and 26
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
The percentage of participants with any markedly abnormal standard vital sign measurements was collected throughout study.
Time frame: From Day 1 to Day 26
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385
Time frame: Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose
Terminal Phase Elimination Half-Life (T1/2) for TAK-385
Time frame: Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose
Oral Clearance (CL/F) for TAK-385
Time frame: Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose