Trials / Not Yet Recruiting
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
| Type | Name | Description |
|---|---|---|
| DRUG | Elecoglipron | Elecoglipron will be administered as oral tablet. |
| DRUG | Atorvastatin | Atorvastatin will be administered as oral tablet. |
| DRUG | Rosuvastatin | Rosuvastatin 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
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07534592. Inclusion in this directory is not an endorsement.