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

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT01025843
Collaborator
(none)
20
Enrollment
10
Arms
5
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: MK-5478
  • Drug: Comparator: Candesartan cilexetil
  • Drug: Comparator: Pbo
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Single Dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of MK5478 in Subjects and in Patients With Hypertension
Actual Study Start Date :
Dec 1, 2009
Actual Primary Completion Date :
May 1, 2010
Actual Study Completion Date :
May 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: 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.

Drug: Comparator: Candesartan cilexetil
Single dose administration of candesartan, 32 mg oral tablet
Other Names:
  • Atacand/Amias

    • Drug: Comparator: Pbo
    Placebo
    Experimental: 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.

    Drug: 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.

    Drug: Comparator: Candesartan cilexetil
    Single dose administration of candesartan, 32 mg oral tablet
    Other Names:
  • Atacand/Amias

    • Drug: Comparator: Pbo
    Placebo
    Experimental: 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.

    Drug: 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.

    Drug: Comparator: Candesartan cilexetil
    Single dose administration of candesartan, 32 mg oral tablet
    Other Names:
  • Atacand/Amias

    • Drug: Comparator: Pbo
    Placebo
    Experimental: 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.

    Drug: 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.

    Drug: Comparator: Candesartan cilexetil
    Single dose administration of candesartan, 32 mg oral tablet
    Other Names:
  • Atacand/Amias

    • Drug: Comparator: Pbo
    Placebo
    Experimental: 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.

    Drug: 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.

    Drug: Comparator: Candesartan cilexetil
    Single dose administration of candesartan, 32 mg oral tablet
    Other Names:
  • Atacand/Amias

    • Drug: Comparator: Pbo
    Placebo
    Experimental: 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.

    Drug: 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.

    Drug: Comparator: Candesartan cilexetil
    Single dose administration of candesartan, 32 mg oral tablet
    Other Names:
  • Atacand/Amias

    • Drug: Comparator: Pbo
    Placebo
    Experimental: 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.

    Drug: 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.

    Drug: Comparator: Candesartan cilexetil
    Single dose administration of candesartan, 32 mg oral tablet
    Other Names:
  • Atacand/Amias

    • Drug: Comparator: Pbo
    Placebo
    Experimental: 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.

    Drug: 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.

    Drug: Comparator: Candesartan cilexetil
    Single dose administration of candesartan, 32 mg oral tablet
    Other Names:
  • Atacand/Amias

    • Drug: Comparator: Pbo
    Placebo
    Experimental: 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.

    Drug: 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.

    Drug: Comparator: Candesartan cilexetil
    Single dose administration of candesartan, 32 mg oral tablet
    Other Names:
  • Atacand/Amias

    • Drug: Comparator: Pbo
    Placebo
    Experimental: 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.

    Drug: 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.

    Drug: Comparator: Candesartan cilexetil
    Single dose administration of candesartan, 32 mg oral tablet
    Other Names:
  • Atacand/Amias

    • Drug: Comparator: Pbo
    Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With One or More Adverse Events (AEs) [Up to 14 days after administration of last dose of study drug (up to Day 52)]

      An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.

    2. Number of Participants Who Discontinued Treatment Due to an AE [Up to 24 hours after administration of study drug]

      An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.

    Secondary Outcome Measures

    1. Area Under the Plasma Concentration Versus Time Curve (AUC 0-infinity) of MK-5478 and Candesartan [Pre-dose and up to 48 hours postdose]

      Blood was collected at the following time points: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours post-dose in order to measure AUC 0-infinity of MK-5478 and Candesartan

    2. Change From Baseline in Aortic Augmentation Index (AIx) of MK-5478 and Candesartan [Baseline and 1 to 3 hours postdose]

      Central blood pressure (CBP) parameters will be measured and used to derive the aortic augmentation index (AIx). The AIx quantifies the contribution of back-reflected outgoing systolic pressure waves to late-systolic central blood pressure, which increases with decreasing aortic compliance. AIx is measured by pulse wave analysis using the SphygmoCor System supplied by AtCor Medical. Results with a > 5% decrease in AIx were planned for analysis; results with a < 5% decrease in AIx were not analysed.

    3. Maximum Plasma Concentration (Cmax) of MK-5478 and Candesartan [Pre-dose and up to 48 hours postdose]

      Blood was collected at the following time points: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours post-dose in order to measure the Cmax of MK-5478 and Candesartan

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    • Study Director: Medical Director, Merck Sharp & Dohme LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT01025843
    Other Study ID Numbers:
    • 5478-001
    • 2009-016048-38
    First Posted:
    Dec 4, 2009
    Last Update Posted:
    Sep 21, 2018
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Hypertension
    Candesartan
    Candesartan cilexetil

    Study Results

    Participant Flow

    Recruitment Details A Part II of this study was planned. However, since the efficacy criteria for advancing to Part II were not met in Part I, this study was considered completed with the completion of Part I. Therefore participants were not recruited for Part II.
    Pre-assignment Detail
    Arm/Group Title Pbo → 5 mg → Candesartan → 24 mg → 38 mg 1 mg → 5 mg → 12 mg → Candesartan → Pbo 1 mg → Candesartan → Pbo → 24 mg → 38 mg 1 mg → 5 mg → 12 mg → Pbo → Candesartan Pbo → 8 mg→ 18 mg → 2 mg Fed → Candesartan 2 mg→Pbo → Candesartan → Pbo Fed → 38 mg 2 mg→Candesartan→ Pbo → Candesartan Fed → 38 mg 2 mg → 8 mg → 18 mg → 2 mg Fed → Pbo Candesartan→8 mg→ 18 mg → 2 mg Fed → 38 mg Candesartan → Pbo → 12 mg → 24 mg → 38 mg
    Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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. 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. 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
    Period Title: Period 1
    STARTED 2 2 2 2 2 2 2 2 2 2
    COMPLETED 2 2 2 2 2 2 2 2 2 2
    NOT COMPLETED 0 0 0 0 0 0 0 0 0 0
    Period Title: Period 1
    STARTED 2 2 2 2 2 2 2 2 2 2
    COMPLETED 2 2 2 2 2 2 2 2 2 2
    NOT COMPLETED 0 0 0 0 0 0 0 0 0 0
    Period Title: Period 1
    STARTED 2 2 2 2 2 2 2 2 2 2
    COMPLETED 2 2 2 2 2 2 2 2 2 2
    NOT COMPLETED 0 0 0 0 0 0 0 0 0 0
    Period Title: Period 1
    STARTED 2 2 2 2 2 2 2 2 2 2
    COMPLETED 2 2 2 2 2 2 2 2 2 2
    NOT COMPLETED 0 0 0 0 0 0 0 0 0 0
    Period Title: Period 1
    STARTED 2 2 2 2 2 2 2 2 2 2
    COMPLETED 2 2 2 2 2 2 2 2 2 2
    NOT COMPLETED 0 0 0 0 0 0 0 0 0 0
    Period Title: Period 1
    STARTED 2 2 2 2 2 2 2 2 2 2
    COMPLETED 2 2 2 2 2 2 2 2 2 2
    NOT COMPLETED 0 0 0 0 0 0 0 0 0 0
    Period Title: Period 1
    STARTED 2 2 2 2 2 2 2 2 2 2
    COMPLETED 2 2 2 2 2 2 2 2 2 2
    NOT COMPLETED 0 0 0 0 0 0 0 0 0 0
    Period Title: Period 1
    STARTED 2 2 2 2 2 2 2 2 2 2
    COMPLETED 2 2 1 1 2 2 2 2 2 2
    NOT COMPLETED 0 0 1 1 0 0 0 0 0 0
    Period Title: Period 1
    STARTED 2 2 1 1 2 2 2 2 2 2
    COMPLETED 2 2 1 1 2 2 2 2 2 2
    NOT COMPLETED 0 0 0 0 0 0 0 0 0 0

    Baseline Characteristics

    Arm/Group Title Pbo → 5 mg → Candesartan → 24 mg → 38 mg 1 mg → 5 mg → 12 mg → Candesartan → Pbo 1 mg → Candesartan → Pbo → 24 mg → 38 mg 1 mg → 5 mg → 12 mg → Pbo → Candesartan Pbo → 8 mg→ 18 mg → 2 mg Fed → Candesartan 2 mg→Pbo → Candesartan → Pbo Fed → 38 mg 2 mg→Candesartan→ Pbo → Candesartan Fed → 38 mg 2 mg → 8 mg → 18 mg → 2 mg Fed → Pbo Candesartan→8 mg→ 18 mg → 2 mg Fed → 38 mg Candesartan → Pbo → 12 mg → 24 mg → 38 mg Total
    Arm/Group Description 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 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. 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. 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. 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. 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. 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. 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. 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. 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 Total of all reporting groups
    Overall Participants 2 2 2 2 2 2 2 2 2 2 20
    Age (Years) [Median (Full Range) ]
    Median (Full Range) [Years]
    46.5
    38.5
    46.0
    35.0
    37.5
    44.5
    48.0
    46.5
    45.0
    39.0
    45.5
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Male
    2
    100%
    2
    100%
    2
    100%
    2
    100%
    2
    100%
    2
    100%
    2
    100%
    2
    100%
    2
    100%
    2
    100%
    20
    100%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With One or More Adverse Events (AEs)
    Description An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.
    Time Frame Up to 14 days after administration of last dose of study drug (up to Day 52)

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
    Arm/Group Title MK-5478 1 mg MK-5478 2 mg MK-5478 5 mg MK-5478 8 mg MK-5478 12 mg MK-5478 18 mg MK-5478 24 mg MK-5478 38 mg MK-5478 2 mg - Fed Candesartan 32 mg Candesartan 32 mg - Fed Candesartan Placebo MK-5478 Placebo
    Arm/Group Description A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period .A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast A single dose of Candesartan placebo in tablet form was orally administered during a treatment period A single dose of MK-5478 Placebo in capsule form was orally administered during a treatment period
    Measure Participants 6 6 6 6 6 6 6 5 6 15 2 2 16
    Number [Participants]
    5
    250%
    3
    150%
    3
    150%
    4
    200%
    4
    200%
    3
    150%
    2
    100%
    2
    100%
    1
    50%
    9
    450%
    0
    0%
    1
    NaN
    6
    NaN
    2. Primary Outcome
    Title Number of Participants Who Discontinued Treatment Due to an AE
    Description An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.
    Time Frame Up to 24 hours after administration of study drug

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
    Arm/Group Title MK-5478 1 mg MK-5478 2 mg MK-5478 5 mg MK-5478 8 mg MK-5478 12 mg MK-5478 18 mg MK-5478 24 mg MK-5478 38 mg MK-5478 2 mg - Fed Candesartan 32 mg Candesartan 32 mg - Fed Candesartan Placebo MK-5478 Placebo
    Arm/Group Description A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period .A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast A single dose of Candesartan placebo in tablet form was orally administered during a treatment period A single dose of MK-5478 Placebo in capsule form was orally administered during a treatment period
    Measure Participants 6 6 6 6 6 6 6 5 6 15 2 2 16
    Number [Participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    NaN
    0
    NaN
    3. Secondary Outcome
    Title Area Under the Plasma Concentration Versus Time Curve (AUC 0-infinity) of MK-5478 and Candesartan
    Description Blood was collected at the following time points: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours post-dose in order to measure AUC 0-infinity of MK-5478 and Candesartan
    Time Frame Pre-dose and up to 48 hours postdose

    Outcome Measure Data

    Analysis Population Description
    In order to keep the study blinded, the scheduled number of treated participants rather than the actual number of treated participants were analyzed; according to the scheduled study drug and not by randomly assigned sequence.
    Arm/Group Title MK-5478 1 mg MK-5478 2 mg MK-5478 5 mg MK-5478 8 mg MK-5478 12 mg MK-5478 18 mg MK-5478 24 mg MK-5478 38 mg MK-5478 2 mg - Fed Candesartan 32 mg Candesartan 32 mg - Fed
    Arm/Group Description A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period .A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
    Measure Participants 6 6 6 6 6 6 6 6 6 16 2
    Mean (Standard Deviation) [umol.hr/L]
    0.236
    (0.141)
    0.494
    (0.202)
    1.87
    (0.538)
    1.80
    (0.436)
    1.36
    (0.448)
    2.23
    (0.582)
    3.15
    (1.55)
    4.50
    (0.857)
    0.504
    (0.07)
    5.89
    (1.38)
    4.46
    (0.314)
    4. Secondary Outcome
    Title Change From Baseline in Aortic Augmentation Index (AIx) of MK-5478 and Candesartan
    Description Central blood pressure (CBP) parameters will be measured and used to derive the aortic augmentation index (AIx). The AIx quantifies the contribution of back-reflected outgoing systolic pressure waves to late-systolic central blood pressure, which increases with decreasing aortic compliance. AIx is measured by pulse wave analysis using the SphygmoCor System supplied by AtCor Medical. Results with a > 5% decrease in AIx were planned for analysis; results with a < 5% decrease in AIx were not analysed.
    Time Frame Baseline and 1 to 3 hours postdose

    Outcome Measure Data

    Analysis Population Description
    Results were not analyzed because none showed a > 5% decrease in AIx.
    Arm/Group Title MK-5478 1 mg MK-5478 2 mg MK-5478 5 mg MK-5478 8 mg MK-5478 12 mg MK-5478 18 mg MK-5478 24 mg MK-5478 38 mg MK-5478 2 mg - Fed Candesartan 32 mg Candesartan 32 mg - Fed
    Arm/Group Description A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period .A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
    Measure Participants 0 0 0 0 0 0 0 0 0 0 0
    5. Secondary Outcome
    Title Maximum Plasma Concentration (Cmax) of MK-5478 and Candesartan
    Description Blood was collected at the following time points: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours post-dose in order to measure the Cmax of MK-5478 and Candesartan
    Time Frame Pre-dose and up to 48 hours postdose

    Outcome Measure Data

    Analysis Population Description
    In order to keep the study blinded, the scheduled number of treated participants rather than the actual number of treated participants were analyzed; according to the scheduled study drug and not by randomly assigned sequence.
    Arm/Group Title MK-5478 1 mg MK-5478 2 mg MK-5478 5 mg MK-5478 8 mg MK-5478 12 mg MK-5478 18 mg MK-5478 24 mg MK-5478 38 mg MK-5478 2 mg - Fed Candesartan 32 mg Candesartan 32 mg - Fed
    Arm/Group Description A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period .A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
    Measure Participants 6 6 6 6 6 6 6 6 6 16 2
    Mean (Standard Deviation) [µmol/L]
    0.0291
    (0.012)
    0.0573
    (0.0206)
    0.254
    (0.0588)
    0.227
    (0.0630)
    0.120
    (0.0332)
    0.245
    (0.0634)
    0.321
    (0.206)
    0.532
    (0.154)
    0.0553
    (0.00891)
    0.476
    (0.194)
    0.451
    (0.0641)

    Adverse Events

    Time Frame 14 days after administration of last dose of study drug (up to Day 52)
    Adverse Event Reporting Description All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.
    Arm/Group Title MK-5478 1 mg MK-5478 2 mg MK-5478 5 mg MK-5478 8 mg MK-5478 12 mg MK-5478 18 mg MK-5478 24 mg MK-5478 38 mg MK-5478 2 mg - Fed MK-5478 Placebo Candesartan 32 mg Candesartan 32 mg - Fed Candesartan Placebo
    Arm/Group Description A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period .A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast A single dose of MK-5478 Placebo in capsule form was orally administered during a treatment period A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast A single dose of Candesartan placebo in tablet form was orally administered during a treatment period
    All Cause Mortality
    MK-5478 1 mg MK-5478 2 mg MK-5478 5 mg MK-5478 8 mg MK-5478 12 mg MK-5478 18 mg MK-5478 24 mg MK-5478 38 mg MK-5478 2 mg - Fed MK-5478 Placebo Candesartan 32 mg Candesartan 32 mg - Fed Candesartan Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    MK-5478 1 mg MK-5478 2 mg MK-5478 5 mg MK-5478 8 mg MK-5478 12 mg MK-5478 18 mg MK-5478 24 mg MK-5478 38 mg MK-5478 2 mg - Fed MK-5478 Placebo Candesartan 32 mg Candesartan 32 mg - Fed Candesartan Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/5 (0%) 0/6 (0%) 0/16 (0%) 0/15 (0%) 0/2 (0%) 0/2 (0%)
    Other (Not Including Serious) Adverse Events
    MK-5478 1 mg MK-5478 2 mg MK-5478 5 mg MK-5478 8 mg MK-5478 12 mg MK-5478 18 mg MK-5478 24 mg MK-5478 38 mg MK-5478 2 mg - Fed MK-5478 Placebo Candesartan 32 mg Candesartan 32 mg - Fed Candesartan Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 5/6 (83.3%) 3/6 (50%) 3/6 (50%) 4/6 (66.7%) 4/6 (66.7%) 3/6 (50%) 2/6 (33.3%) 2/5 (40%) 1/6 (16.7%) 6/16 (37.5%) 9/15 (60%) 0/2 (0%) 1/2 (50%)
    Eye disorders
    Eye haemorrhage 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/2 (0%) 0 0/2 (0%) 0
    Gastrointestinal disorders
    Abdominal discomfort 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/15 (0%) 0 0/2 (0%) 0 0/2 (0%) 0
    Abdominal pain 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/2 (0%) 0 0/2 (0%) 0
    Diarrhoea 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/15 (0%) 0 0/2 (0%) 0 0/2 (0%) 0
    Dyspepsia 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/15 (0%) 0 0/2 (0%) 0 0/2 (0%) 0
    Loose stools 2/6 (33.3%) 2 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/5 (20%) 1 0/6 (0%) 0 0/16 (0%) 0 1/15 (6.7%) 1 0/2 (0%) 0 0/2 (0%) 0
    Toothache 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/15 (6.7%) 1 0/2 (0%) 0 0/2 (0%) 0
    General disorders
    Fatigue 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/5 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/15 (6.7%) 1 0/2 (0%) 0 0/2 (0%) 0
    Influenza like illness 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/15 (6.7%) 1 0/2 (0%) 0 0/2 (0%) 0
    Infusion site haematoma 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/5 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/2 (0%) 0 0/2 (0%) 0
    Thirst 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/15 (6.7%) 1 0/2 (0%) 0 0/2 (0%) 0
    Vessel puncture site haematoma 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/15 (6.7%) 1 0/2 (0%) 0 0/2 (0%) 0
    Infections and infestations
    Gastroenteritis 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/2 (0%) 0 0/2 (0%) 0
    Nasopharyngitis 1/6 (16.7%) 1 2/6 (33.3%) 2 1/6 (16.7%) 1 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 1/15 (6.7%) 1 0/2 (0%) 0 0/2 (0%) 0
    Pharyngitis 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/5 (20%) 1 0/6 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/2 (0%) 0 0/2 (0%) 0
    Upper respiratory tract infection 0/6 (0%) 0 2/6 (33.3%) 3 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/2 (0%) 0 0/2 (0%) 0
    Injury, poisoning and procedural complications
    Excoriation 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/15 (6.7%) 1 0/2 (0%) 0 0/2 (0%) 0
    Procedural dizziness 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/2 (0%) 0 0/2 (0%) 0
    Skin laceration 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/2 (0%) 0 0/2 (0%) 0
    Investigations
    Alanine aminotransferase increased 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/5 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/2 (0%) 0 0/2 (0%) 0
    Aspartate aminotransferase increased 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/5 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/2 (0%) 0 0/2 (0%) 0
    Blood glucose increased 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/2 (0%) 0 0/2 (0%) 0
    Creatine phosphokinase increased 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 2 0/5 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/2 (0%) 0 0/2 (0%) 0
    Eosinophil count increased 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/5 (20%) 1 0/6 (0%) 0 0/16 (0%) 0 1/15 (6.7%) 2 0/2 (0%) 0 0/2 (0%) 0
    Musculoskeletal and connective tissue disorders
    Back pain 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/15 (0%) 0 0/2 (0%) 0 0/2 (0%) 0
    Myalgia intercostal 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/15 (0%) 0 0/2 (0%) 0 0/2 (0%) 0
    Neck pain 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/2 (0%) 0 0/2 (0%) 0
    Nervous system disorders
    Dizziness 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 2/6 (33.3%) 2 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 0/15 (0%) 0 0/2 (0%) 0 0/2 (0%) 0
    Dizziness postural 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/15 (6.7%) 1 0/2 (0%) 0 0/2 (0%) 0
    Headache 2/6 (33.3%) 2 1/6 (16.7%) 1 1/6 (16.7%) 1 0/6 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1 1/6 (16.7%) 1 0/5 (0%) 0 0/6 (0%) 0 3/16 (18.8%) 3 2/15 (13.3%) 2 0/2 (0%) 0 1/2 (50%) 1
    Muscle contractions involuntary 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 2 0/15 (0%) 0 0/2 (0%) 0 0/2 (0%) 0
    Somnolence 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/15 (6.7%) 1 0/2 (0%) 0 0/2 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Dry throat 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/15 (6.7%) 1 0/2 (0%) 0 0/2 (0%) 0
    Skin and subcutaneous tissue disorders
    Skin irritation 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/15 (0%) 0 0/2 (0%) 0 0/2 (0%) 0
    Vascular disorders
    Facial flushing 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 1/16 (6.3%) 1 0/15 (0%) 0 0/2 (0%) 0 0/2 (0%) 0
    Orthostatic hypotension 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 0/6 (0%) 0 0/16 (0%) 0 1/15 (6.7%) 1 0/2 (0%) 0 0/2 (0%) 0
    Systolic hypertension 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/5 (0%) 0 1/6 (16.7%) 1 0/16 (0%) 0 0/15 (0%) 0 0/2 (0%) 0 0/2 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts,or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.

    Results Point of Contact

    Name/Title Senior Vice President, Global Clinical Development
    Organization Merck Sharp & Dohme Corp.
    Phone 1-800-672-6372
    Email ClinicalTrialsDisclosure@merck.com
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT01025843
    Other Study ID Numbers:
    • 5478-001
    • 2009-016048-38
    First Posted:
    Dec 4, 2009
    Last Update Posted:
    Sep 21, 2018
    Last Verified:
    Aug 1, 2018