Study S000228

Pharmacokinetics, Safety, and Tolerability of a Solution Formulation of LY3298176 in Healthy Subjects

ClinicalTrials.gov record Study Protocol: GPGE 05 Protocol Addenda (1) (PDF)Study Protocol: GPGE 05 Protocol (a) (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT03375463
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: DOUBLE
Status: COMPLETED
Enrollment: 52
Start: 2017-12-19
Primary completion: 2018-12-27
Lead sponsor: Eli Lilly and Company
Conditions: Healthy
Interventions: DRUG:Tirzepatide; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: NO
Secondary identifiers: OTHER:I8F-MC-GPGE

Registered primary outcomes

Pharmacokinetics (PK) Part A: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide [Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480, 816-864 hours postdose]
PK Part A: Maximum Observed Drug Concentration (Cmax) of Tirzepatide [Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480 and 816-864 hours postdose]
PK Part B: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide [Part B: Predose, 0.08 hours (h), 0.16h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 816h-864h and >=70 days post dose]

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