A Drug-Drug Interaction (DDI) Study of Orforglipron With Carbamazepine in Healthy Participants

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Eli Lilly and Company
Study ID
NCT06370728
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Orforglipron — DRUG
    Administered orally
  • Carbamazepine — DRUG
    Administered orally

Study Details

The main purpose of this study is to assess the effect of carbamazepine on the amount of orforglipron in the bloodstream and how long it takes the body to get rid of orforglipron when given orally in healthy study participants. The safety and tolerability of orforglipron and carbamazepine when given separately or together will also be evaluated. The study may last up to approximately 77 days for each participant.

Key Dates

First listed
Apr 17, 2024
Start date
May 6, 2024
Status verified
Jun 2026
Primary completion
Jul 23, 2024
Completion
Jul 23, 2024

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Orforglipron + Carbamazepine
    Participants received study intervention through oral administration as follows: * Day 1: 1 milligram (mg) orforglipron capsule alone * Days 6 to 8: Twice daily (BID) doses of 100 mg carbamazepine tablets * Days 9 to 11: BID doses of 200 mg carbamazepine tablets * Days 12 to 14: BID doses of 300 mg carbamazepine tablets * Day 15: 1 mg orforglipron capsule co-administered with BID doses of 300 mg carbamazepine tablets * Days 16 to 18: BID doses of 300 mg carbamazepine tablets

Primary Outcome Measure

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Orforglipron [ Time Frame: Day 1 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose); Day 15 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose) ]

Locations (1)

FacilityCityStateZIPSite coordinators
ICON Early Phase ServicesSan AntonioTexas78209-

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