CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 50 enrolled
Drug / intervention
MK-8723 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01963260
NCT01963260Phase 1Completed
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A Two-Part, Single Rising Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of MK-8723 in Healthy Adults and Patients With Immune Thrombocytopenia Purpura

Merck Sharp & Dohme LLC·interventional·Posted Oct 16, 2013·Updated Mar 15, 2019

In Brief

A Phase 1 clinical trial evaluating MK-8723 and Matching Placebo for Immune Thrombocytopenia Purpura. Completed, enrolled 50 participants.

Detailed 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%.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImmune Thrombocytopenia Purpura
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 16, 2013
Enrollment StartOct 31, 2013
Primary CompletionApr 26, 2015
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 12.7 years ago

Interventions

MK-8723drug

MK-8723 administered as a single IV infusion over approximately 4 hours on Day 1.

Matching Placebodrug

Matching placebo to MK-8723 administered as a single IV infusion over approximately 4 hours on Day 1.