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

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.

Conditions

• Hypertension
• Isolated Systolic Hypertension (ISH)

Interventions

DRUG

MK-8150 2.0 mg

Single oral 2.0-mg dose of MK-8150

DRUG

MK-8150 10 mg

Single oral 10-mg dose of MK-8150

DRUG

MK-8150 40 mg

Single oral 40-mg dose of MK-8150 without food (fasted) and with food (fed)

DRUG

MK-8150 90 mg

Single oral 90-mg dose of MK-8150

DRUG

MK-8150 5.0 mg

Single oral 5.0-mg dose of MK-8150

DRUG

MK-8150 20 mg

Single oral 20-mg dose of MK-8150

DRUG

MK-8150 60 mg

Single oral 60-mg dose of MK-8150

DRUG

MK-8150 120 mg

Single oral 120-mg dose of MK-8150

DRUG

MK-8150 160 mg

Single oral 160-mg dose of MK-8150

DRUG

MK-8150 320 mg

Single oral 320-mg dose of MK-8150

DRUG

MK-8150 600 mg

Single oral 600-mg dose of MK-8150

DRUG

MK-8150 900 mg

Single oral 900-mg dose of MK-8150

DRUG

MK-8150 1200 mg

Single oral 1200-mg dose of MK-8150

DRUG

Placebo for MK-8150

Single oral dose-matched dose of Placebo for MK-8150

DRUG

MK-8150 50 mg

Single oral 50-mg dose of MK-8150

DRUG

MK-8150 100 mg

Single oral 100-mg dose of MK-8150

DRUG

MK-8150 200 mg

Single oral 200-mg dose of MK-8150

DRUG

MK-8150 400 mg

Single oral 400-mg dose of MK-8150

DRUG

MK-8150 500 mg

Single oral 500-mg dose of MK-8150

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  lead INDUSTRY

Principal Investigators

• Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-05-07

Primary Completion

2013-01-24

Completion

2013-02-05