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

Part of paid clinical trials in Glendale, California.

Sponsor
AstraZeneca
Study ID
NCT07534592
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Elecoglipron — DRUG
    Elecoglipron will be administered as oral tablet.
  • Atorvastatin — DRUG
    Atorvastatin will be administered as oral tablet.
  • Rosuvastatin — DRUG
    Rosuvastatin will be administered as oral tablet.

Study Details

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.

Key Dates

Start date
Apr 16, 2026
Status verified
May 2026
Primary completion
Sep 18, 2026
Completion
Sep 18, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: Period 1
    Participants will receive a single dose of atorvastatin on Day 1.
  • Experimental: Group 1: Period 2
    Participants will receive single dose of atorvastatin on Day 5 and then receive multiple doses of elecoglipron from Day 7 to Day 40.
  • Experimental: Group 1: Period 3
    Participants will receive single dose of atorvastatin on Day 41 and then receive multiple doses of elecoglipron from Day 41 to Day 43.
  • Experimental: Group 1: Period 4
    Participants will receive elecoglipron in the morning and a single dose of atorvastatin in the evening on Day 44. Participant will continue elecoglipron on Day 45. Participants will receive daily administration of different doses of elecoglipron alone from Day 46 to Day 58.
  • Experimental: Group 1: Period 5
    Participants will receive single dose of atorvastatin and elecoglipron on Day 59. Participants will receive elecoglipron alone on Day 60 to Day 61.
  • Experimental: Group 1: Period 6
    Participants will receive elecoglipron in the morning and a single dose of atorvastatin in the evening on Day 62. Participant will continue elecoglipron alone from Day 63 to Day 64.
  • Experimental: Group 2: Period 1
    Participants will receive single dose of rosuvastatin on Day 1 and then multiple doses of elecoglipron from Day 5 to Day 38.
  • Experimental: Group 2: Period 2
    Participants will receive elecoglipron in the morning along with a single dose of rosuvastatin on Day 39. Participant will continue elecoglipron alone from Day 40 to Day 44.
  • Experimental: Group 2: Period 3
    Participants will receive elecoglipron in the morning and a single dose of rosuvastatin in the evening on Day 45. Participant will continue on different doses of elecoglipron alone from Day 46 to Day 59.
  • Experimental: Group 2: Period 4
    Participants will receive elecoglipron in the morning along with a single dose of rosuvastatin on Day 60. Participant will continue elecoglipron alone from Day 61 to Day 65.
  • Experimental: Group 2: Period 5
    Participants will receive elecoglipron in the morning and a single dose of rosuvastatin in the evening on Day 66. Participant will continue on elecoglipron alone from Day 67 to Day 69.

Primary Outcome Measure

Area under concentration-time curve from time 0 to infinity (AUCinf) of atorvastatin [ Time Frame: Group 1: Day 1 to Day 71 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Research SiteGlendaleCalifornia91206-
Research SiteBrooklynMaryland21225-

Find similar trials in Glendale, CA

By research site
Research Site· Glendale, CAResearch Site· Brooklyn, MD

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