A Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Ascending Oral Doses of GS-4571 in Healthy Participants, Multiple Ascending Oral Doses of GS-4571 in Nondiabetic Obese Participants and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM), and to Evaluate the Effect of Food and an Acid-Reducing Agent on Pharmacokinetics of GS-4571
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
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• Individuals must be glucagon-like peptide-1 receptor agonist (GLP-1RA) naïve OR last dose was at least 6 months prior to screening.
• Part A (SAD) and Part B (Food/PPI Effect): eligible individuals in Cohorts 1-4, (optional cohort 5) and 6 will include healthy individuals with BMI of ≥ 19 and \< 30 kg/m\^2, and no significant medical history.
⁃ Individuals will also be in good general health as determined by the investigator at the screening evaluation performed no more than 28 days prior to the scheduled first dose.
• Part C (MAD in nondiabetic obese individuals): Eligible individuals in Cohorts 7-9 and (optional cohort 10) will be individuals with obesity with BMI ≥ 30 kg/m\^2 and \< 45 kg/m\^2 with a total body weight \> 50 kg, and nondiabetic (HbA1c \< 6.5%). Eligible individuals will also be individuals with stable body weight (\< 5% change) for 90 days prior to screening visit based on individual report.
• Part D (multiple doses in non-obese T2DM): eligible individuals in Cohort 11 will be individuals with T2DM HbA1c ≥ 7.0% and ≤ 10.5% with BMI of ≥ 19 and \< 30 kg/m\^2 and treated with diet and/or exercise, and/or metformin monotherapy.
Locations
United States
Texas
ICON Early Phase Services, LLC
RECRUITING
San Antonio
Utah
ICON
RECRUITING
Salt Lake City
Contact Information
Primary
Gilead Clinical Study Information Center
GileadClinicalTrials@gilead.com
1-833-445-3230 (GILEAD-0)
Time Frame
Start Date:2024-08-28
Estimated Completion Date:2026-07
Participants
Target number of participants:134
Treatments
Experimental: Part A Single-ascending Dose (SAD) in Healthy Participants
Participants will be randomized into 4 + (optional) 1 dose escalating cohorts and will receive GS-4571 or placebo to match (PTM) GS-4571 on Day 1, to determine the maximum tolerated dose:~* Cohort 1: Dose 1 GS-4571, administered orally as a single dose, in a fasting state.~* Cohort 2: Dose 2 GS-4571, administered orally as a single dose, in a fasting state.~* Cohort 3: Dose 3 GS-4571, administered orally as a single dose, in a fasting state.~* Cohort 4: Dose 4 GS-4571, administered orally as a single dose, in a fasting state.~* Cohort 5 (optional): Dose 5 GS-4571, administered orally as a single dose, in a fasting state.
Experimental: Part B Food/PPI Effect in Healthy Participants
Participants will be randomized into 2 sequence groups in Cohort 6 and will receive the highest dose found to be safe and well tolerated in Part A of GS-4571 and omeprazole. The two sequential groups will receive the following treatments:~* Treatment A: Up to the highest single dose of GS-4571 evaluated in Part A, fasting.~* Treatment B: Up to the highest single dose of GS-4571 evaluated in Part A, nonfasting (high-fat/high-calorie meal).~* Treatment C (optional): Omeprazole, once-daily (QD) for 5 days, fasting.~* Treatment D (optional): Omeprazole followed by up to the highest single dose of GS-4571 evaluated in Part A, 2 hours later, fasting.
Experimental: Part C Multiple-ascending Dose (MAD) in Nondiabetic Obese Participants
Participants randomized in Cohorts 7-9 will be randomized to receive up to 4 escalating doses of GS-4571 or PTM QD for 12 weeks, as follows:~* Cohort 7: Up to dose determined from Part A of GS-4571 or PTM in obese participants, QD, in a non-fasting state~* Cohort 8: Up to 3-fold the Cohort 7 dose of GS-4571 or PTM in obese participants, QD, in a non-fasting state~* Cohort 9: Up to 2-fold the Cohort 8 dose of GS-4571 or PTM in obese participants, QD, in a non-fasting state~* Cohort 10 is optional and will receive GS-4571 or PTM QD for 12 weeks in case it is opened for enrollment as follows:~ * Up to 2-fold the Cohort 9 dose of GS-4571 or PTM in obese participants, QD, in a non-fasting state.
Experimental: Part D Multiple Dose in Nonobese Participants With T2DM
Participants randomized in Cohort 11 will receive up to the highest dose of GS-4571 or PTM in T2DM, QD, in a non-fasting state for 12 weeks.