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Not Yet RecruitingNCT07534592

A Study to Investigate the Effect of Elecoglipron on Rosuvastatin and Atorvastatin in Healthy Participants

An Open-label, Fixed-sequence Study to Assess the Effect of Elecoglipron on the Pharmacokinetics of Rosuvastatin and Atorvastatin in Healthy Participants

Status
Not Yet Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
AstraZeneca · Industry
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Accepted

Summary

The study has 2 groups, one each focusing on co-administration of elecoglipron and atorvastatin or rosuvastatin to assess the pharmacokinetics (PK) of atorvastatin in healthy participants.

Detailed description

This is an open-label, fixed-sequence, conducted at 2 study centers with 2 groups. Group 1 is designed to assess the PK of atorvastatin in healthy participants when administered alone and in combination with multiple doses of elecoglipron. This group will consist of a screening period, 6 treatment periods, and a follow-up visit. Each participant in Group 1 will be involved in the study for approximately 15 weeks. Group 2 is designed to assess the PK of rosuvastatin in healthy participants when administered alone and in combination with multiple doses of elecoglipron. This group will consist of a screening period, 5 treatment periods, and a follow-up visit. Each participant in Group 2 will be involved in the study for approximately 16 weeks. Group 1 and Group 2 are independent and non-sequential parts in this study. All parts of this study will be performed in healthy male and female participants

Conditions

Interventions

TypeNameDescription
DRUGElecoglipronElecoglipron will be administered as oral tablet.
DRUGAtorvastatinAtorvastatin will be administered as oral tablet.
DRUGRosuvastatinRosuvastatin will be administered as oral tablet.

Timeline

Start date
2026-04-12
Primary completion
2026-09-11
Completion
2026-09-11
First posted
2026-04-16
Last updated
2026-04-16

Locations

2 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT07534592. Inclusion in this directory is not an endorsement.