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

Start date
May 6, 2024
Status verified
Jul 2024
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
    Single dose of orforglipron along with twice-daily dose of carbamazepine administered orally

Primary Outcome Measure

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-∞]) of Orforglipron [ Time Frame: Predose up to Day 18 ]

Locations (1)

FacilityCityStateZIPSite coordinators
ICON Early Phase ServicesSan AntonioTexas78209-

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ICON Early Phase Services· San Antonio, TX

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