drugset / Trial / NCT01590810

A Single Rising Dose Study of MK-8150 (MK-8150-001)

Phase 1 Completed 34 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

This study will evaluate the safety and tolerability of MK-8150 and its effect on central systolic blood pressure (cSBP) and heart rate corrected augmentation index (AIx) when given as single oral doses in healthy males and in males with mild-to-moderate hypertension. A primary study hypothesis is that post dose mean change from baseline of time-weighted average across 24 hours (TWA0-24hrs) cSBP or AIx is reduced in participants administered MK-8150 compared to placebo in males with mild to moderate hypertension. A mean decrease from baseline compared to placebo of ≥5 mm Hg in TWA0-24hrs cSBP or of ≥5 percentage points in TWA0-24hrs AIx is considered clinically meaningful.

Timeline

Start: 2012-05-07
Primary completion: 2013-01-24
Completion: 2013-02-05

Outcome

Mixed primary results

registry Panel A - MK-8150 6 mg vs Panel A - Placebo; p <0.0001; LS Mean Difference -2.20 (95% CI -2.86 to -1.55) NCT01590810 ↗

registry Panel C - MK-8150 5 mg vs Panel C - Placebo; p = 0.241; LS Mean Difference -1.45 (95% CI -4.01 to 1.12) NCT01590810 ↗

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	2 mg	Oral
Subject	MK-8150	Other / unclassified	5 mg	Oral
Subject	MK-8150	Other / unclassified	10 mg	Oral
Subject	MK-8150	Other / unclassified	20 mg	Oral
Subject	MK-8150	Other / unclassified	40 mg	Oral
Subject	MK-8150	Other / unclassified	50 mg	Oral
Subject	MK-8150	Other / unclassified	60 mg	Oral
Subject	MK-8150	Other / unclassified	90 mg	Oral
Subject	MK-8150	Other / unclassified	100 mg	Oral
Subject	MK-8150	Other / unclassified	120 mg	Oral
Subject	MK-8150	Other / unclassified	160 mg	Oral
Subject	MK-8150	Other / unclassified	200 mg	Oral
Subject	MK-8150	Other / unclassified	320 mg	Oral
Subject	MK-8150	Other / unclassified	400 mg	Oral
Subject	MK-8150	Other / unclassified	500 mg	Oral
Subject	MK-8150	Other / unclassified	600 mg	Oral
Subject	MK-8150	Other / unclassified	900 mg	Oral
Subject	MK-8150	Other / unclassified	1200 mg	Oral