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

NCT ID: NCT01590810

Last Updated: 2018-09-25

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-07

Study Completion Date

2013-02-05

Brief Summary

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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.

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Detailed Description

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Up to three planned panels (A, B and C) of either 8 healthy participants or 8 participants with mild to moderate hypertension will be enrolled. For Panel A and Panel B, dosing will occur in an alternating fashion between Panel A and Panel B with dosing commencing in Panel A. Participants will receive alternating single rising oral doses of MK-8150 or placebo in up to 5 treatment periods (Periods 1 through 5). Subsequent doses in any Panel will be administered only after careful evaluation of safety, tolerability, and pharmacodynamic effects of a given dose. For Panel C, participants will receive single rising oral doses of MK-8150 or placebo in up to 5 treatment periods (Periods 1 through 5). Depending on safety, tolerability and hemodynamic effects observed in the healthy participants, Panels A and/or B may be truncated and dosing may proceed in Panel C with hypertensive participants. In this case, dosing of hypertensive participants in Panel C will start with the second highest dose achieved in healthy participants.

Amendment 1 of the protocol added Panel D (healthy males) based on the pharmacokinetic, pharmacodynamic and safety results from Panels A-C. Participants in Panel D will receive single rising oral doses of MK-8150 or placebo in up to 5 treatment periods (Periods 1 through 5) at a dose range of 50 mg to 500 mg of MK-8150. Each treatment period will be approximately 3-4 days apart.

Conditions

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Hypertension Isolated Systolic Hypertension (ISH)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Panel A-Healthy

Within each of the 5 treatment periods, 6 participants will be randomly assigned to receive MK-8150, and 2 will be randomly assigned to receive matching placebo according to a computer-generated allocation schedule. The dose range of MK-8150 for Panel A will be 2.0 mg to 90 mg.

Group Type EXPERIMENTAL

MK-8150 2.0 mg

Intervention Type DRUG

Single oral 2.0-mg dose of MK-8150

MK-8150 10 mg

Intervention Type DRUG

Single oral 10-mg dose of MK-8150

MK-8150 40 mg

Intervention Type DRUG

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

MK-8150 90 mg

Intervention Type DRUG

Single oral 90-mg dose of MK-8150

Placebo for MK-8150

Intervention Type DRUG

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

Panel B-Healthy

Within each of the 5 treatment periods, 6 participants will be randomly assigned to receive MK-8150, and 2 will be randomly assigned to receive matching placebo according to a computer-generated allocation schedule. The dose range of MK-8150 for Panel B will be 5.0 mg to 160 mg.

Group Type EXPERIMENTAL

MK-8150 5.0 mg

Intervention Type DRUG

Single oral 5.0-mg dose of MK-8150

MK-8150 20 mg

Intervention Type DRUG

Single oral 20-mg dose of MK-8150

MK-8150 60 mg

Intervention Type DRUG

Single oral 60-mg dose of MK-8150

MK-8150 120 mg

Intervention Type DRUG

Single oral 120-mg dose of MK-8150

MK-8150 160 mg

Intervention Type DRUG

Single oral 160-mg dose of MK-8150

Placebo for MK-8150

Intervention Type DRUG

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

Panel C-Mild/Moderate Hypertension

Within each of the 5 treatment periods, 6 participants will be randomly assigned to receive MK-8150, and 2 will be randomly assigned to receive matching placebo according to a computer-generated allocation schedule. The dose range of MK-8150 for Panel C will be 160 mg to 1200 mg.

Group Type EXPERIMENTAL

MK-8150 160 mg

Intervention Type DRUG

Single oral 160-mg dose of MK-8150

MK-8150 320 mg

Intervention Type DRUG

Single oral 320-mg dose of MK-8150

MK-8150 600 mg

Intervention Type DRUG

Single oral 600-mg dose of MK-8150

MK-8150 900 mg

Intervention Type DRUG

Single oral 900-mg dose of MK-8150

MK-8150 1200 mg

Intervention Type DRUG

Single oral 1200-mg dose of MK-8150

Placebo for MK-8150

Intervention Type DRUG

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

Panel D-Healthy

Within each panel, 8 subjects will be randomly assigned to MK-8150 and 2 subjects will be randomly assigned to placebo throughout the 5 periods according to a computer-generated allocation schedule. The dose range of MK-8150 for Panel D will be 50 mg to 500 mg.

Group Type EXPERIMENTAL

Placebo for MK-8150

Intervention Type DRUG

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

MK-8150 50 mg

Intervention Type DRUG

Single oral 50-mg dose of MK-8150

MK-8150 100 mg

Intervention Type DRUG

Single oral 100-mg dose of MK-8150

MK-8150 200 mg

Intervention Type DRUG

Single oral 200-mg dose of MK-8150

MK-8150 400 mg

Intervention Type DRUG

Single oral 400-mg dose of MK-8150

MK-8150 500 mg

Intervention Type DRUG

Single oral 500-mg dose of MK-8150

Interventions

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MK-8150 2.0 mg

Single oral 2.0-mg dose of MK-8150

Intervention Type DRUG

MK-8150 10 mg

Single oral 10-mg dose of MK-8150

Intervention Type DRUG

MK-8150 40 mg

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

Intervention Type DRUG

MK-8150 90 mg

Single oral 90-mg dose of MK-8150

Intervention Type DRUG

MK-8150 5.0 mg

Single oral 5.0-mg dose of MK-8150

Intervention Type DRUG

MK-8150 20 mg

Single oral 20-mg dose of MK-8150

Intervention Type DRUG

MK-8150 60 mg

Single oral 60-mg dose of MK-8150

Intervention Type DRUG

MK-8150 120 mg

Single oral 120-mg dose of MK-8150

Intervention Type DRUG

MK-8150 160 mg

Single oral 160-mg dose of MK-8150

Intervention Type DRUG

MK-8150 320 mg

Single oral 320-mg dose of MK-8150

Intervention Type DRUG

MK-8150 600 mg

Single oral 600-mg dose of MK-8150

Intervention Type DRUG

MK-8150 900 mg

Single oral 900-mg dose of MK-8150

Intervention Type DRUG

MK-8150 1200 mg

Single oral 1200-mg dose of MK-8150

Intervention Type DRUG

Placebo for MK-8150

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

Intervention Type DRUG

MK-8150 50 mg

Single oral 50-mg dose of MK-8150

Intervention Type DRUG

MK-8150 100 mg

Single oral 100-mg dose of MK-8150

Intervention Type DRUG

MK-8150 200 mg

Single oral 200-mg dose of MK-8150

Intervention Type DRUG

MK-8150 400 mg

Single oral 400-mg dose of MK-8150

Intervention Type DRUG

MK-8150 500 mg

Single oral 500-mg dose of MK-8150

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Between 18 and 50 years of age for Panels A, B and D, or between 18 and 60 years of age (inclusive) for Panel C.
* Systolic blood pressure (SBP) \> 110 and ≤ 140 mmHg for Panels A, B, and D or SBP values of 140-175 mmHg and diastolic blood pressure (DBP) of 90-105 mmHg on at least three different occasions at the prestudy (screening) visit for Panel C. Participants being treated with medication for their hypertension may be included as long as they are titrated off of their medication
* Body Mass Index (BMI) ≥ 18 kg/m\^2 and ≤ 32 kg/m\^2
* Healthy (with the exception of hypertensive subjects in Panel C)
* No clinically significant abnormality on electrocardiogram (ECG)
* No history of clinically significant cardiac disease
* No history of heart failure
* Nonsmoker and/or has not used nicotine or nicotine-containing products for at least 6 months

Exclusion Criteria

* Mentally or legally incapacitated
* History of stroke, chronic seizures, or major neurological disorder
* History of clinically significant endocrine, gastrointestinal, cardiovascular (except mild to moderate hypertension), hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
* Functional disability that can interfere with rising from a sitting position to the standing position
* History of neoplastic disease (cancer)
* Unable to refrain from or anticipates the use of any medication during the study
* Anticipates using medication for erectile dysfunction during the study
* Uses or anticipates using organic nitrates during the study (e.g. nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, pentaerythritol)
* Anticipates using cytochrome P450 inhibitors (e.g. ketoconazole) or inducers (e.g. rifampin) during the study
* Consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages per day
* Consumes excessive amounts, defined as greater than 6 servings of coffee, tea, cola, or other caffeinated beverages per day
* Has had major surgery, donated or lost 1 unit of blood or participated in another investigational study within 4 weeks
* History of significant multiple and/or severe allergies (including latex allergy)
* Regular user (including recreational user) of illicit drugs or has a history of drug (including alcohol) abuse within approximately 1 year
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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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.

Reference Type RESULT
PMID: 27561272 (View on PubMed)

Study Documents

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Document Type: CSR Synopsis

View Document

Other Identifiers

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2012-001281-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

8150-001

Identifier Type: -

Identifier Source: org_study_id

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