drugset / Trial / NCT01963260

Single Rising Dose Study of MK-8723 in Healthy Participants and Participants With Immune Thrombocytopenia Purpura (MK-8723-001)

NCT01963260 ↗

Phase 1 Completed 50 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objectives of this study are to assess the safety and tolerability of single rising doses of MK-8723 in healthy adult participants and adult participants with chronic immune thrombocytopenia purpura (ITP) and to assess pharmacodynamics of MK-8723 in participants with ITP. The primary hypothesis is that the true placebo-adjusted platelet response rate to MK-8723 in adult patients with chronic ITP is \>50%.

Timeline

Start
2013-10-31
Primary completion
2015-04-26
Completion
2015-04-26

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-8723 Unknown 1 mg/kg Intravenous
Subject MK-8723 Unknown 3 mg/kg Intravenous
Subject MK-8723 Unknown 10 mg/kg Intravenous
Subject MK-8723 Unknown 30 mg/kg Intravenous
Subject MK-8723 Unknown 100 mg/kg Intravenous