The goal of this clinical study is to learn more about the study drug, GS-4571, and how safe it is in 3 groups, i) Healthy participants, ii) Healthy non-diabetic obese participants, and iii) Non-obese participants with Type 2 Diabetes Mellitus (T2DM). The primary objectives of this study are: * To characterize the pharmacokinetics (PK) of GS-4571 following single and multiple ascending oral doses of GS-4571. * To evaluate the effect of concomitant food intake and (if conducted) a representative acid-reducing agent (proton pump inhibitor (PPI), omeprazole) on the PK of GS-4571. * To evaluate the safety and tolerability of single and multiple ascending oral doses of GS-4571.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
134
Administered orally
Administered orally
Administered orally
Qps-Mra, Llc.
Miami, Florida, United States
RECRUITINGICON Early Phase Services, LLC
San Antonio, Texas, United States
RECRUITINGICON
Salt Lake City, Utah, United States
RECRUITINGSingle-Dose PK Parameter AUCinf of GS-4571
AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time.
Time frame: Up to 96 hours postdose
Single-Dose PK Parameter Cmax of GS-4571
Cmax is defined as the maximum observed concentration of drug in plasma.
Time frame: Up to 96 hours postdose
Multiple-Dose Plasma PK Parameter: AUCtau of GS-4571
AUCtau is defined as area under the concentration versus time curve over the dosing interval.
Time frame: Up to 96 hours postdose
Multiple-Dose Plasma PK Parameter: Cmax of GS-4571
Cmax is defined as the maximum observed concentration of drug in plasma.
Time frame: Up to 96 hours postdose
Percentage of Participants of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Deaths
Time frame: Day 1 up to 95 days
Percentage of Participants of Treatment-Emergent Laboratory Abnormalities
Time frame: Day 1 up to 95 days
Percentage Change From Baseline (CFB) in Body Weight in Nondiabetic Obese Participants
Time frame: Day 1 up to 95 days
Gilead Clinical Study Information Center
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