Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562907
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
Study of GS-4571 in Healthy Participants Nondiabetic Obese Participants and Nonobese Participants With Type 2 Diabetes Mellitus T2DM
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 effectiveness of a representative gastric acid-reducing agent proton pump inhibitor PPI omeprazole on the PK of GS-4571
To evaluate the effectiveness of concomitant food intake on the PK of GS-4571
To evaluate the safety and tolerability of single and multiple ascending oral doses of GS-4571
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 effectiveness of a representative gastric acid-reducing agent proton pump inhibitor PPI omeprazole on the PK of GS-4571
To evaluate the effectiveness of concomitant food intake on the PK of GS-4571
To evaluate the safety and tolerability of single and multiple ascending oral doses of GS-4571
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None