This is a two-part study is to evaluate the multi-day safety, tolerability, and pharmacokinetics (PK) of orally administered GS-441524 in a healthy human volunteer.
Part 1: 750 mg GS-441524 administered once daily (QD) for 7 days. Part 2: 750 mg GS-441524 administered three times daily (TID) for 3 days.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
750 mg administered as a solution
Copycat Sciences Study Site
Houston, Texas, United States
Emergence of treatment-related adverse events (AEs)
Treatment-related AEs are defined as significant changes to blood chemistry (CBC, CMP) or 6-lead ECG.
Time frame: Day 7
Pharmacokinetic (PK) Parameter: AUC0-24h of GS-441524 in Parts 1 and 2.
AUC0-24h is defined as the concentration of drug over time between time 0 to time 24 hours.
Time frame: Intensive PK: Day 1 to Day 7
PK Parameter: AUClast of GS-441524 in Parts 1 and 2.
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Time frame: Intensive PK: Day 1 to Day 7
PK Parameter: T1/2 of GS-441524 in Parts 1 and 2.
T/2 is defined as the estimate of the terminal elimination half-life of the drug
Time frame: Intensive PK: Day 1 to Day 7
PK Parameter: Cmax of GS-441524 in Parts 1 and 2.
Cmax is defined as the maximum observed concentration of drug.
Time frame: Intensive PK: Day 1 to Day 7
PK Parameter: Tmax of GS-441524 in Parts 1 and 2.
Tmax is defined as the time (observed time point) of Cmax.
Time frame: Intensive PK: Day 1 to Day 7
PK Parameter: Clast of GS-441524 in Parts 1 and 2.
Clast is defined as the last observable concentration of drug.
Time frame: Intensive PK: Day 1 to Day 7
PK Parameter: Tlast of GS-441524 in Parts 1 and 2.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tlast is defined as the time (observed time point) of Clast.
Time frame: Intensive PK: Day 1 to Day 7
PK Parameter: AUCtau of GS-441524 in Parts 1 and 2.
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Time frame: Intensive PK: Day 1 to Day 7