drugset / Trial / NCT02055547

A Single and Multiple-Dose Study of MK-8521 in Healthy and Obese Males (MK-8521-002)

NCT02055547

Phase 1 Completed 61 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-8521. Part 1 primary hypothesis: Administration of single subcutaneous (SC) doses of MK-8521 is sufficiently safe and well- tolerated in healthy participants, based on assessment of clinical and laboratory adverse experiences, to permit continued clinical investigation. Part 2: Administration of multiple once daily SC doses of MK-8521 is sufficiently safe and well-tolerated in healthy lean and obese participants, based on assessment of clinical and laboratory adverse experiences, to permit continued clinical investigation.

Timeline

Start
2013-05-10
Primary completion
2013-09-17
Completion
2013-09-17

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-8521 Unknown 35 ug Subcutaneous
Subject MK-8521 Unknown 72 ug Subcutaneous
Subject MK-8521 Unknown 100 ug Subcutaneous
Subject MK-8521 Unknown 125 ug Subcutaneous
Subject MK-8521 Unknown 150 ug Subcutaneous
Subject MK-8521 Unknown 175 ug Subcutaneous
Subject MK-8521 Unknown 200 ug Subcutaneous
Subject MK-8521 Unknown 300 ug Subcutaneous