Safety and Tolerability of MK-5478 in Participants With Hypertension (5478-001)

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-01

Study Completion Date

2010-05-01

Brief Summary

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This is a two part introductory clinical trial with MK-5478. Part I will evaluate the safety, tolerability and pharmacokinetics and pharmacodynamics of MK-5478 in young, healthy males. Part II will evaluate the safety, tolerability and pharmacodynamic effects of MK-5478 in participants with hypertension. The primary hypothesis is that single oral doses of MK-5478 are sufficiently safe and well tolerated.

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Detailed Description

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Conditions

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Hypertension

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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Pbo → 5 mg → Candesartan → 24 mg → 38 mg

Placebo in Period 1; 5 mg MK-5478 in Period 2; Candesartan in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.

Group Type EXPERIMENTAL

MK-5478

Intervention Type DRUG

In Part I: Single dose administration of MK-5478 oral capsules, total doses of 1, 2, 5, 8, 12, 18, 24 or 38 mg.

Comparator: Candesartan cilexetil

Intervention Type DRUG

Single dose administration of candesartan, 32 mg oral tablet

Comparator: Pbo

Intervention Type DRUG

Placebo

1 mg → 5 mg → 12 mg → Candesartan → Pbo

1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Candesartan in Period 4; and Placebo in Period 5. There was a minimum 7 days washout between periods.

Group Type EXPERIMENTAL

MK-5478

Intervention Type DRUG

In Part I: Single dose administration of MK-5478 oral capsules, total doses of 1, 2, 5, 8, 12, 18, 24 or 38 mg.

Comparator: Candesartan cilexetil

Intervention Type DRUG

Single dose administration of candesartan, 32 mg oral tablet

Comparator: Pbo

Intervention Type DRUG

Placebo

1 mg → Candesartan → Pbo → 24 mg → 38 mg

1 mg MK-5478 in Period 1; Candesartan in Period 2: Placebo in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.

Group Type EXPERIMENTAL

MK-5478

Intervention Type DRUG

In Part I: Single dose administration of MK-5478 oral capsules, total doses of 1, 2, 5, 8, 12, 18, 24 or 38 mg.

Comparator: Candesartan cilexetil

Intervention Type DRUG

Single dose administration of candesartan, 32 mg oral tablet

Comparator: Pbo

Intervention Type DRUG

Placebo

1 mg → 5 mg → 12 mg → Pbo → Candesartan

1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Placebo in Period 4; and Candesartan in Period 5. There was a minimum 7 days washout between periods.

Group Type EXPERIMENTAL

MK-5478

Intervention Type DRUG

In Part I: Single dose administration of MK-5478 oral capsules, total doses of 1, 2, 5, 8, 12, 18, 24 or 38 mg.

Comparator: Candesartan cilexetil

Intervention Type DRUG

Single dose administration of candesartan, 32 mg oral tablet

Comparator: Pbo

Intervention Type DRUG

Placebo

Pbo→ 8 mg→ 18 mg → 2 mg fed→Candesartan

Placebo in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Candesartan in Period 5. There was a minimum 7 days washout between periods.

Group Type EXPERIMENTAL

MK-5478

Intervention Type DRUG

In Part I: Single dose administration of MK-5478 oral capsules, total doses of 1, 2, 5, 8, 12, 18, 24 or 38 mg.

Comparator: Candesartan cilexetil

Intervention Type DRUG

Single dose administration of candesartan, 32 mg oral tablet

Comparator: Pbo

Intervention Type DRUG

Placebo

2 mg→Pbo → Candesartan → Pbo fed→38 mg

2 mg MK-5478 in Period 1; Placebo in Period 2; Candesartan in Period 3; Placebo in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.

Group Type EXPERIMENTAL

MK-5478

Intervention Type DRUG

In Part I: Single dose administration of MK-5478 oral capsules, total doses of 1, 2, 5, 8, 12, 18, 24 or 38 mg.

Comparator: Candesartan cilexetil

Intervention Type DRUG

Single dose administration of candesartan, 32 mg oral tablet

Comparator: Pbo

Intervention Type DRUG

Placebo

2 mg→Candesartan→Pbo→Candesartan fed→38 mg

2 mg MK-5478 in Period 1; Candesartan in Period 2; Placebo in Period 3; Candesartan in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.

Group Type EXPERIMENTAL

MK-5478

Intervention Type DRUG

In Part I: Single dose administration of MK-5478 oral capsules, total doses of 1, 2, 5, 8, 12, 18, 24 or 38 mg.

Comparator: Candesartan cilexetil

Intervention Type DRUG

Single dose administration of candesartan, 32 mg oral tablet

Comparator: Pbo

Intervention Type DRUG

Placebo

2 mg → 8 mg → 18 mg → 2 mg fed → Pbo

2 mg MK-5478 in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Placebo in Period 5. There was a minimum 7 days washout between periods.

Group Type EXPERIMENTAL

MK-5478

Intervention Type DRUG

In Part I: Single dose administration of MK-5478 oral capsules, total doses of 1, 2, 5, 8, 12, 18, 24 or 38 mg.

Comparator: Candesartan cilexetil

Intervention Type DRUG

Single dose administration of candesartan, 32 mg oral tablet

Comparator: Pbo

Intervention Type DRUG

Placebo

Candesartan→8 mg→ 18 mg →2 mg fed→38 mg

Candesartan in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.

Group Type EXPERIMENTAL

MK-5478

Intervention Type DRUG

In Part I: Single dose administration of MK-5478 oral capsules, total doses of 1, 2, 5, 8, 12, 18, 24 or 38 mg.

Comparator: Candesartan cilexetil

Intervention Type DRUG

Single dose administration of candesartan, 32 mg oral tablet

Comparator: Pbo

Intervention Type DRUG

Placebo

Candesartan→Pbo → 12 mg → 24 mg→38 mg

Candesartan in Period 1; Placebo in Period 2; 12 mg MK-5478 in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.

Group Type EXPERIMENTAL

MK-5478

Intervention Type DRUG

In Part I: Single dose administration of MK-5478 oral capsules, total doses of 1, 2, 5, 8, 12, 18, 24 or 38 mg.

Comparator: Candesartan cilexetil

Intervention Type DRUG

Single dose administration of candesartan, 32 mg oral tablet

Comparator: Pbo

Intervention Type DRUG

Placebo

Interventions

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MK-5478

In Part I: Single dose administration of MK-5478 oral capsules, total doses of 1, 2, 5, 8, 12, 18, 24 or 38 mg.

Intervention Type DRUG

Comparator: Candesartan cilexetil

Single dose administration of candesartan, 32 mg oral tablet

Intervention Type DRUG

Comparator: Pbo

Placebo

Intervention Type DRUG

Other Intervention Names

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Atacand/Amias

Eligibility Criteria

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Inclusion Criteria

Part I:

* Is a male between 18 to 50 years of age
* Is in good health
* Is a non-smoker

Part II:

* Is male of non-child bearing potential between 18 and 50 years of age
* Has hypertension (high blood pressure)

Exclusion Criteria

Part I and Part II:

* Has a history of stroke, seizures or major neurological disorder
* Has a history of cancer
* Has a history of any cardiovascular disease
* Is unable to refrain from the use of any prescription or non-prescription drugs
* Consumes excessive amounts of alcohol or caffeine
* Has had major surgery, donated blood or participated in another investigational study in the past 4 weeks

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes