GS-4571
DrugAdministered orally
NCT Number: NCT06562907
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.
Interested in participating?
Request Info18 year–55 year
All sexes
Interventional
Phase 1
Qps-Mra, Llc., Miami, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
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.
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Administered orally
Administered orally
Administered orally
Time frame: Up to 96 hours postdose
AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time.
Time frame: Up to 96 hours postdose
Cmax is defined as the maximum observed concentration of drug in plasma.
Time frame: Up to 96 hours postdose
AUCtau is defined as area under the concentration versus time curve over the dosing interval.
Time frame: Up to 96 hours postdose
Cmax is defined as the maximum observed concentration of drug in plasma.
Time frame: Day 1 up to 95 days
Time frame: Day 1 up to 95 days
Time frame: Day 1 up to 95 days
Contact information is provided by the study sponsor or research team.
Gilead Sciences
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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