Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06567327
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
A Study to Learn How the Study Medicine Danuglipron is Taken Up Into the Blood and If Danuglipron Changes How the Body Processes Other Study Medicines Atorvastatin and Rosuvastatin in Healthy Adults Who Are Overweight or Obese
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A TWO-PART PHASE 1 OPEN- LABEL FIXED-SEQUENCE STUDY TO EVALUATE THE MULTIPLE DOSE PHARMACOKINETICS OF DANUGLIPRON FOLLOWING ORAL ADMINISTRATION AND THE EFFECTS OF STEADY-STATE DANUGLIPRON ON THE PHARMACOKINETICS OF SINGLE ORAL DOSE OF ATORVASTATIN AND ROSUVASTATIN IN OTHERWISE HEALTHY ADULT PARTICIPANTS WITH OVERWEIGHT OR OBESITY
Status:
RECRUITING
Status Verified Date:
2024-09
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 purpose of this study is to learn the following about the study medicine danuglipron after multiple days of dosing in healthy adults who are overweight or obese
how the study medicine danuglipron is taken up into the blood
if the study medicine danuglipron changes how the body processes other study medicines Atorvastatin and Rosuvastatin
about the safety and tolerability of danuglipron
The study will take place in 2 Cohorts groups The total number of weeks of the study is about 23 about 6 months for Cohort 1 and 22 weeks about 55 months for Cohort 2
how the study medicine danuglipron is taken up into the blood
if the study medicine danuglipron changes how the body processes other study medicines Atorvastatin and Rosuvastatin
about the safety and tolerability of danuglipron
The study will take place in 2 Cohorts groups The total number of weeks of the study is about 23 about 6 months for Cohort 1 and 22 weeks about 55 months for Cohort 2
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