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
ICON 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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