DRUG
Orforglipron
Administered orally
Status
Completed
Phase
Phase 1
Enrollment
30
Locations
1
Results
Posted
Publications
0
Study 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.
Interventions
DRUG
Administered orally
DRUG
Administered orally
Timeline
First posted
Apr 17, 2024
Study start
May 6, 2024
Primary completion
Jul 23, 2024
Study completion
Jul 23, 2024
Results posted
Jul 17, 2026
Registry updated
Jul 17, 2026
Outcomes
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)
PK: AUC (0-∞) of Orforglipron
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) 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)
PK: AUC (0-tlast) of Orforglipron
PK: Maximum Observed Concentration (Cmax) 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)
PK: Cmax of Orforglipron
Not reported in the indexed record.
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.
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
ICON Early Phase Services
San Antonio, Texas, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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