The Effect of Hypertension Medications on Renal Blood Flow Measurements in Healthy Males (MK-0000-127)

Merck Sharp & Dohme LLC12 enrolled

Overview

This study will evaluate the effect of Aliskiren and Losartan on renal blood flow using PAH clearance, PC MRA and ASL MRI methodologies.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypertension

Interventions

AliskirenDRUG

Single dose of four 150 mg tablets (600 mg total) Aliskiren in one of three study periods. There will be at least 10 days between each study period.

AliskirenDRUG

Single dose of one 150 mg tablet of Aliskiren in one of three study periods. There will be at least 10 days between each study period.

Comparator: LosartanDRUG

Single dose of one 100 mg tablet Losartan in one of three study periods. There will be at least 10 days between each study period.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is in generally good health * Subject is willing to avoid unaccustomed strenuous exercise during the study * Subject agrees to consume ONLY the study-specified diet during all domiciled periods * Subject has been a non-smoker for at least 3 months prior to study * Subject will refrain from smoking or using any tobacco products during the study * Subject agrees to refrain from consuming alcohol or caffeine during the domiciled periods and agrees to limit alcohol and caffeine consumption throughout the study Exclusion Criteria: * Subject has contraindication to MRI scans * Subject has a history of stroke, seizure, or major neurological disorders * Subject uses illicit drugs or has a history of drug/alcohol abuse * Subject has had major surgery, has donated or lost 1 unit of blood, or has been in another investigational study in the last 4 weeks * Subject has a history of multiple and/or severe allergies to drugs or food

Outcomes

Primary Outcomes

change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Aliskiren

Time frame: 2-5 hours post dose of study drug

Secondary Outcomes

change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Losartan

Time frame: 2-5 hours post dose of study drug

Data from ClinicalTrials.gov

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