An Open-label, Fixed-sequence Study to Assess the Effect of Elecoglipron on the Pharmacokinetics of Rosuvastatin and Atorvastatin in Healthy Participants
AstraZeneca
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.
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…
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit. * Females of childbearing potential must not be lactating and if heterosexually active, must agree to use an approved method of highly effective contraception throughout the study. * Females of non-childbearing potential must be confirmed as postmenopausal or have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion at screening visit. * Sexually active f…
Interventions
- DrugElecoglipron
Elecoglipron will be administered as oral tablet.
- DrugAtorvastatin
Atorvastatin will be administered as oral tablet.
- DrugRosuvastatin
Rosuvastatin will be administered as oral tablet.
Locations (2)
- Research SiteGlendale, California
- Research SiteBrooklyn, Maryland