A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8150 (MK-8150-002)

Summary

This randomized, double-blind, placebo-controlled, multiple-rising-dose study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-8150 in healthy young men, in male participants with mild to moderate hypertension, in elderly male and female participants with mild to moderate hypertension, and in male and female participants with resistant hypertension. A primary study hypothesis is that there is at least one dose that does not increase heart rate (HR) to a clinically meaningful extent in male participants with mild to moderate hypertension and in elderly participants with mild to moderate hypertension on either Day 1 or the last Day of multiple dosing (Daylast), as measured by Time-weighted Average Across 24 hours (TWA0-24hrs). The hypothesis is met if mean increase (MK-8150 - placebo) in TWA0-24hrs HR in the identified groups is ≤15 beats per minute on Day 1 and Daylast.

Timeline

Start

2012-08-01

Primary completion

2013-05-03

Completion

2013-05-23

Outcome

Mixed primary results

registry Panel J - MK-8150 10/20 mg vs Panel J - Placebo; p = 0.003; LS Mean Difference -11.3 (90% CI -16.8 to -5.9); Mixed Models Analysis NCT01656408 ↗

registry Panel J - MK-8150 10/20 mg vs Panel J - Placebo; p = 0.691; LS Mean Difference -1.4 (90% CI -7.5 to 4.6); Mixed Models Analysis NCT01656408 ↗

Publications

• Results Knox CD, de Kam PJ, Azer K, Wong P, Ederveen AG, Shevell D, Morabito C, Meehan AG, Liu W, Reynders T, Denef JF, Mitselos A, Jonathan D, Gutstein DE, Mitra K, Sun SY, Lo MM, Cully D, Ali A. Discovery and Clinical Evaluation of MK-8150, A Novel Nitric Oxide Donor With a Unique Mechanism of Nitric Oxide Release. J Am Heart Assoc. 2016 Aug 25;5(9):e003493. doi: 10.1161/JAHA.116.003493.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MK-8150	Other / unclassified	—	Oral

Indications