At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 50 enrolled

Drug / intervention

MK-8616 +1 moredrug

Likely dose

MK-8616 8.0 mg/kgfrom 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/NCT03519867

NCT03519867Phase 2Completed

Compare CT.gov

A Multi-center, Randomized, Assessor-blinded, Phase II, Parallel Dose-finding Trial in Subjects of ASA Class 1 - 3 to Assess the Efficacy and Safety of 5 Doses of Org 25969 When Administered at 1-2 PTCs After Administration of Zemuron®

Merck Sharp & Dohme LLC·interventional·Posted May 9, 2018·Updated Jan 31, 2019

In Brief

A Phase 2 clinical trial evaluating MK-8616 and Zemuron® for Neuromuscular Blockade. Completed, enrolled 50 participants.

Detailed Summary

The primary objective of this study is to explore the dose-response relation of MK-8616 (Org 25969) given as a reversal agent of Zemuron® at 1 to 2 post tetanic counts (PTCs); both Zemuron® and MK-8616 are administered by intravenous (iv) infusion. Another goal of the study is to evaluate the safety of single doses of MK-8616 administered to participants of American Society of Anesthesiologists (ASA) Physical Status Class 1 (otherwise normal, healthy participant); Class 2 (participant with a mild systemic disease); or Class 3 (participant with a severe systemic disease that limits activity, but is not incapacitating).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsNeuromuscular Blockade

Countries--

Collaborators--

Timeline

Phase 2CompletedFinished

200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartAug 2004

Primary CompletionMay 2005

First PostedMay 2018

TodayJul 2026

First PostedMay 9, 2018

Enrollment StartAug 1, 2004

Primary CompletionMay 26, 2005

TodayJul 2, 2026

Enrollment to primary: 10 monthsPosted 8.1 years ago

Interventions

MK-8616drug

MK-8616 will be administered at doses of 0.5, 1.0, 2.0, 4.0 and 8.0 mg/kg iv as a 30-second infusion. Doses are based on actual body weight.

Zemuron®drug

Zemuron® (0.6 or 1.2 mg/kg, iv) will be administered as a 10-second bolus infusion to achieve 1 to 2 PTCs. If needed, a maintenance dose of 0.15 mg/kg will be given. Doses are based on actual body weight.