A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8266 in Hypertensive Men (MK-8266-002)

Summary

This study evaluated adverse events (AEs), study discontinuation due to AEs, and pharmacodynamics of MK-8266 in male participants with mild to moderate hypertension.

Conditions

• Hypertension

Interventions

DRUG

MK-8226 BID, 1 mg

MK-8266 1 mg administered as oral capsules (0.7 mg + 0.3 mg), BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B.

DRUG

MK-8266 BID, 1.8 mg

MK-8266 1.8 mg administered as oral capsules (1 mg + 0.8 mg), BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C.

DRUG

MK-8266 TID, 1.8 mg

MK-8266 1.8 mg administered as oral capsules (0.6 mg), TID for 10 consecutive days. Panel C was completed prior to initiation of Panel D.

DRUG

MK-8266 TID, 2.4 mg

MK-8266 TID (Panel D), 2.4 mg administered as oral capsules (0.8 mg), TID for 10 consecutive days. Panel D was completed prior to initiation of Panel E.

DRUG

MK-8266 TID, 2.4 mg

MK-8266 TID (Panel E), 2.4 mg administered as oral capsules (0.8 mg), TID for 10 consecutive days. Panel E was initiated after completion of Panel D.

DRUG

Placebo BID (Panel A)

Placebo administered as oral capsules BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B.

DRUG

Placebo BID (Panel B)

Placebo administered as oral capsules BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C.

DRUG

Placebo TID (Panel C)

Placebo administered as oral capsules TID for 10 consecutive days. Panel C was completed prior to initiation of Panel D.

DRUG

Placebo TID (Panel D)

Placebo administered as oral capsules TID for 10 consecutive days. Panel D was completed prior to initiation of Panel E.

DRUG

Placebo TID (Panel E)

Placebo administered as oral capsules TID for 10 consecutive days. Panel E was initiated after completion of Panel D.

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

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-03-01

Primary Completion

2010-11-01

Completion

2010-11-01