Study S001457

A Drug-Drug Interaction, Single-arm, Open-label Study to Assess the Effect of Quinidine on the Pharmacokinetics of Orforglipron in Healthy Participants

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT06704763
Study type: INTERVENTIONAL
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 27
Start: 2024-12-06
Primary completion: 2025-02-05
Lead sponsor: Eli Lilly and Company
Conditions: Healthy
Interventions: DRUG:Orforglipron; DRUG:Midazolam; DRUG:Quinidine
Results posted: TRUE
Individual participant data sharing: NO
Secondary identifiers: OTHER:J2A-MC-GZPP

Registered primary outcomes

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Orforglipron [Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours post orforglipron dose on days 1, 8]
PK: Maximum Observed Concentration (Cmax) of Orforglipron [Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours post orforglipron dose on days 1, 8]

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