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

Healthy Clinical Trial

Official title:

A Drug-Drug Interaction Study to Assess the Effect of Carbamazepine on the Pharmacokinetics of Orforglipron in Healthy Participants

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06370728
• Other study ID #: 18621
• Secondary ID: J2A-MC-GZPJ
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 3, 2024
• Est. completion date: July 15, 2024

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]Lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Orforglipron
Administered orally
• Carbamazepine
Administered orally

Locations

Country	Name	City	State
United States	ICON Early Phase Services	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-8]) of Orforglipron	PK: AUC (0-8) of Orforglipron	Predose up to Day 18
Primary	PK: Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Orforglipron	PK: AUC (0-tlast) of Orforglipron	Predose up to Day 18
Primary	PK: Maximum Observed Concentration (Cmax) of Orforglipron	PK: Cmax of Orforglipron	Predose up to Day 18