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Completed

NCT Number: NCT01025843

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

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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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-5478

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

Drug

Single dose administration of candesartan, 32 mg oral tablet

Other names: Atacand/Amias

Comparator: Pbo

Drug

Placebo

Primary outcomes

  1. Number of Participants With One or More Adverse Events (AEs)

    Time frame: 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

    Time frame: 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 outcomes

  1. Area Under the Plasma Concentration Versus Time Curve (AUC 0-infinity) of MK-5478 and Candesartan

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Single Dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of MK5478 in Subjects and in Patients With Hypertension

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 4, 2009
Registry last updated
Sep 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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