Study S000260

A Phase 1 Multiple-Dose Study to Investigate the Pharmacokinetics, Safety, and Tolerability of 2 Different Formulations of LY3502970 in Healthy Participants

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

Registration

Registration: NCT05341089
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 39
Start: 2022-05-17
Primary completion: 2022-09-01
Lead sponsor: Eli Lilly and Company
Conditions: Healthy
Interventions: DRUG:LY3502970
Results posted: TRUE
Individual participant data sharing: NO
Secondary identifiers: OTHER:J2A-MC-GZGH

Registered primary outcomes

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 in Formulation 1 and Formulation 2 [Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose]
PK: Area Under the Plasma Concentration-Time Curve (AUC) From 0 to 24 Hours (AUC (0-24)) of LY3502970 in Formulation 1 and Formulation 2 [Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose]
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Formulation 1 and Formulation 2 [Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose]

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