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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Orforglipron; Drug: Carbamazepine

• Registration Number: NCT06370728
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-15
• Study First Posted: 2024-04-17
• Study Start: 2024-05-06
• Status Verified: 2024-07
• Primary Completion: 2024-07-23
• Study Completion: 2024-07-23
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Participants must be overtly healthy individuals, assigned male at birth (AMAB) or individuals not of childbearing potential (INOCBP).

• Have a body weight equal to or greater than 45 kg, and body mass index (BMI) between 18.5 and 35.0 kilograms per meter squared (kg/m²), inclusive, at screening.

• Have a hemoglobin level of

  • at least 11.4 g/dL for individuals assigned female at birth (AFAB) and
  • at least 12.5 g/dL for AMAB.

• Have venous access sufficient to allow for blood sampling.

Exclusion Criteria

• Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking orforglipron; or of interfering with the interpretation of data.
• Have an abnormal 12-lead electrocardiogram (ECG).
• Have human leucocyte antigen-B (HLA-B)*1502 or HLA-A*3101 allele; participants with other alleles that demonstrate strong evidence of association with carbamazepine-induced hypersensitivity reaction or hepatic impairment may also be excluded.
• Have a history or presence of multiple or severe allergies, or severe post treatment hypersensitivity reactions.
• Have known allergies to carbamazepine or to orforglipron, related compounds, or any components of the formulation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Orforglipron + Carbamazepine	Orforglipron	Single dose of orforglipron along with twice-daily dose of carbamazepine administered orally
Orforglipron + Carbamazepine	Carbamazepine	Single dose of orforglipron along with twice-daily dose of carbamazepine administered orally

Primary Outcome Measures

Name	Time	Method
PK: Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Orforglipron	Predose up to Day 18	PK: AUC (0-tlast) of Orforglipron
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-∞]) of Orforglipron	Predose up to Day 18	PK: AUC (0-∞) of Orforglipron
PK: Maximum Observed Concentration (Cmax) of Orforglipron	Predose up to Day 18	PK: Cmax of Orforglipron

Trial Locations

Locations (1)

ICON Early Phase Services; 🇺🇸 San Antonio, Texas, United States