The purpose of this study is to study the safety and tolerability of a single dose of PLX5622 in healthy, adult human volunteers. This will be the first time PLX5622 has been taken by humans.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
32
Cetero Research
Fargo, North Dakota, United States
Safety-Number of patients with adverse events
Subjects will take one oral dose of PLX5622 on Day 1. Physical examinations, vital signs, 12-lead electrocardiograms (ECG), adverse events, hematology, serum chemistry, coagulation, and urinalysis will be used to assess safety throughout the Days 1-4 of the study and on the follow up study visit on day 7. Adverse events will be monitored and reviewed for safety issues/abnormal changes in the above mentioned tests.
Time frame: 7 days
Tolerability-Number of patients with adverse events
Subjects will take one oral dose of PLX5622 on Day 1. Physical examinations, vital signs, 12-lead electrocardiograms (ECG), adverse events, hematology, serum chemistry, coagulation, and urinalysis will be used to assess safety throughout the Days 1-4 of the study and on the follow up study visit on day 7. Adverse events will be monitored and reviewed for tolerability issues/abnormal changes in the above mentioned tests.
Time frame: 7 days
Pharmacokinetic profile: Measurement of area under the plasma-concentration-time curve
Pharmacokinetic (PK) samples will be collected prior to dosing and at 0.5, 1, 2, 4, 8, 12, 24, 26, 48, 60 and 72 hours following dosing. The pharmacokinetic profile of plasma PLX5622 will be analyzed by measurement of area under the plasma concentration-time curve \[AUC0-t, AUC0-inf, AUC0-24\].
Time frame: 7 days
Pharmacokinetic evaulation: Measurement of Peak Concentration
Pharmacokinetic (PK) samples will be collected prior to dosing and at 0.5, 1, 2, 4, 8, 12, 24, 26, 48, 60 and 72 hours following dosing. The pharmacokinetic profile of plasma PLX5622 will be analyzed by measurement of peak concentration (Cmax) and time to peak concentration (Tmax).
Time frame: 7 days
Pharmacokinetic profile: Measurement of half life and terminal elimination rate constant
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Pharmacokinetic (PK) samples will be collected prior to dosing and at 0.5, 1, 2, 4, 8, 12, 24, 26, 48, 60 and 72 hours following dosing. The pharmacokinetic profile of plasma PLX5622 will be analyzed by measurement of half-life (T1/2), and terminal elimination rate constant (Kel).
Time frame: 7 Days