A Single Dose Study of MK-8266 (MK-8266-001)

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 1

Conditions

Hypertension

Treatments

Drug: MK-8266 0.1 mg
Drug: Placebo
Drug: MK-8266 1.0 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01025791
2009-015774-36 (EudraCT Number)
8266-001
2009_700 (Other Identifier)
MK-8266-001 (Other Identifier)

Details and patient eligibility

About

A three panel study, to determine if MK-8266 given as a single dose is sufficiently safe and well tolerated. Panel A and B will consist of healthy young males and Panel C will consist of subjects with mild to moderate hypertension. The primary hypotheses for the study are that MK-8266 given as single doses is sufficiently safe and well tolerated to permit continued clinical investigation in healthy young male volunteers and male participants with mild-to-moderate hypertension and that in males with mild to moderate hypertension, at a single oral dose of MK-8266 that is sufficiently safe and well-tolerated, postdose mean time-weighted average across 24 hours of aortic augmentation index (TWA0-12hrs AIx) is reduced compared to placebo. A mean decrease of ≥ 5 percentage points is considered clinically meaningful.

Full description

Three panels, each consisting of either 8 or 9 participants (8 healthy young males in Panel A and Panel B; and 9 participants with mild to moderate hypertension in Panel C) will be randomized to receive either MK-8266 or matching placebo in either a 6:2 ratio (Panel A and Panel B) or 6:3 ratio (Panel C), respectively, in up to 5 treatment (1 to 5) periods in Panel A and up to 4 treatment (1 to 4) periods in Panel B and Panel C. In all panels, doses will be escalated in a rising, fixed sequence. Some participants took study drug after fasting and some with food.

Enrollment

25 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • For Panel A and B Participant is a healthy male between 18 to 45 years of age. For Panel C Participant is a male with essential hypertension between 18 to 55 years of age
  • A non-smoker

Exclusion criteria

  • Has a history of stroke, chronic seizure or major neurological disorder
  • Has a disability that can interfere with rising from a sitting position to the standing position
  • Has a personal of family history of bleeding or clotting disorders
  • Has a history of cancer
  • Is unable to refrain from or anticipates the use of any prescription or nonprescription drug during the study
  • Consumes excessive amounts of caffeine or alcohol
  • Has had major surgery, donated blood or participated in another investigational study in the past 4 weeks

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

25 participants in 14 patient groups, including a placebo group

Panel A, Healthy Male Participants, Sequence 1
Experimental group
Description:
MK-8266 in Period 1: 0.1 mg/ Period 2: 0.2 mg/ Period 3: placebo/ Period 4: 1.0 mg/ Period 5: 1.0 mg dose followed in 6 hours by a 0.8 mg dose.
Treatment:
Drug: MK-8266 1.0 mg
Drug: Placebo
Drug: MK-8266 0.1 mg
Panel A, Healthy Male Participants, Sequence 2
Experimental group
Description:
MK-8266 in Period 1: 0.1 mg/ Period 2: 0.2 mg/ Period 3: 0.5 mg/ Period 4: placebo/ Period 5: 1.0 mg dose followed in 6 hours by a 0.8 mg dose.
Treatment:
Drug: MK-8266 1.0 mg
Drug: Placebo
Drug: MK-8266 0.1 mg
Panel A, Healthy Male Participants, Sequence 3
Experimental group
Description:
MK-8266 in Period 1: 0.1 mg/ Period 2: placebo/ Period 3: 0.5/ Period 4: 1.0 mg/ Period 5: placebo.
Treatment:
Drug: MK-8266 1.0 mg
Drug: Placebo
Drug: MK-8266 0.1 mg
Panel A, Healthy Male Participants, Sequence 4
Experimental group
Description:
MK-8266 in Period 1: placebo/ Period 2: 0.2 mg/ Period 3: 0.5 mg/ Period 4: 1.0 mg/ Period 5: 1.0 mg dose followed in 6 hours by a 0.8 mg dose.
Treatment:
Drug: MK-8266 1.0 mg
Drug: Placebo
Drug: MK-8266 0.1 mg
Panel B, Healthy Male Participants, Sequence 1
Experimental group
Description:
MK-8266 in Period 1: 0.4 mg/ Period 2: 1.2 mg/ Period 3: placebo/ Period 4: 0.4 mg fed/ Period 5: na.
Treatment:
Drug: MK-8266 1.0 mg
Drug: Placebo
Drug: MK-8266 0.1 mg
Panel B, Healthy Male Participants, Sequence 2
Experimental group
Description:
MK-8266 in Period 1: 0.4 mg/ Period 2: placebo/ Period 3: 1.2 mg dose followed in 6 hours by a 0.6 mg dose/ Period 4: 0.4 mg fed/ Period 5: na.
Treatment:
Drug: MK-8266 1.0 mg
Drug: Placebo
Drug: MK-8266 0.1 mg
Panel B, Healthy Male Participants, Sequence 3
Experimental group
Description:
MK-8266 in Period 1: 0.4 mg/ Period 2: 1.2 mg/ Period 3: 1.2 mg dose followed in 6 hours by a 0.6 mg dose/ Period 4: 0.4 mg fed/ Period 5: na.
Treatment:
Drug: MK-8266 1.0 mg
Drug: MK-8266 0.1 mg
Panel B, Healthy Male Participants, Sequence 4
Experimental group
Description:
MK-8266 in Period 1: placebo/ Period 2: 1.2 mg/ Period 3: 1.2 mg dose followed in 6 hours by a 0.6 mg dose/ Period 4: placebo/ Period 5: na.
Treatment:
Drug: MK-8266 1.0 mg
Drug: Placebo
Drug: MK-8266 0.1 mg
Panel C, Mild/Moderate Hypertension, Sequence 1
Experimental group
Description:
Period 1: placebo/ Period 2 1.2 mg dose followed in 8 hours by a 1.0 mg dose/ Period 3: 1.0 mg dose followed in 6 hours by a 0.6 mg dose followed in 6 hours by a 0.6 mg dose/ Period 4: 1.0 mg dose followed in 6 hours by a 1.0 mg dose followed in 6 hours by a 0.6 mg dose/ Period 5: na
Treatment:
Drug: MK-8266 1.0 mg
Drug: MK-8266 0.1 mg
Panel C, Mild/Moderate Hypertension, Sequence 2
Experimental group
Description:
Period 1: placebo/ Period 2 1.2 mg dose followed in 8 hours by a 1.0 mg dose/ Period 3: 1.0 mg dose followed in 6 hours by a 0.6 mg dose followed in 6 hours by a 0.6 mg dose/ Period 4: placebo/ Period 5: na
Treatment:
Drug: MK-8266 1.0 mg
Drug: Placebo
Drug: MK-8266 0.1 mg
Panel C, Mild/Moderate Hypertension, Sequence 3
Experimental group
Description:
Period 1: 1.0 mg dose followed in 8 hours by a 0.8 mg dose/ Period 2 placebo/ Period 3: 1.0 mg dose followed in 6 hours by a 0.6 mg dose followed in 6 hours by a 0.6 mg dose/ Period 4: 1.0 mg dose followed in 6 hours by a 1.0 mg dose followed in 6 hours by a 0.6 mg dose/ Period 5: na
Treatment:
Drug: MK-8266 1.0 mg
Drug: Placebo
Drug: MK-8266 0.1 mg
Panel C, Mild/Moderate Hypertension, Sequence 4
Experimental group
Description:
Period 1: 1.0 mg dose followed in 8 hours by a 0.8 mg dose/ Period 2: placebo/ Period 3: 1.0 mg dose followed in 6 hours by a 0.6 mg dose followed in 6 hours by a 0.6 mg dose/ Period 4: placebo/ Period 5: na
Treatment:
Drug: MK-8266 1.0 mg
Drug: Placebo
Drug: MK-8266 0.1 mg
Panel C, Mild/Moderate Hypertension, Sequence 5
Experimental group
Description:
Period 1: 1.0 mg dose followed in 8 hours by a 0.8 mg dose/ Period 2: 1.2 mg dose followed in 8 hours by a 1.0 mg dose// Period 3: placebo/ Period 4: 1.0 mg dose followed in 6 hours by a 1.0 mg dose followed in 6 hours by a 0.6 mg dose/ Period 5: na
Treatment:
Drug: MK-8266 1.0 mg
Drug: MK-8266 0.1 mg
Panel C, Mild/Moderate Hypertension, Sequence 6
Placebo Comparator group
Description:
Period 1: 1.0 mg dose followed in 8 hours by a 0.8 mg dose/ Period 2: 1.2 mg dose followed in 8 hours by a 1.0 mg dose// Period 3: placebo/ Period 4: placebo/ Period 5: na
Treatment:
Drug: MK-8266 1.0 mg
Drug: Placebo
Drug: MK-8266 0.1 mg

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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