Hypertension
Conditions
Brief summary
This study will evaluate the effect of Aliskiren and Losartan on renal blood flow using PAH clearance, PC MRA and ASL MRI methodologies.
Interventions
DRUGAliskiren
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.
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.
DRUGComparator: Placebo to Aliskiren
Three or four tablets placebo to Aliskiren 150 mg in one of three study periods. There will be at least 10 days between each study period.
DRUGComparator: Placebo to Losartan
Single dose of placebo to Losartan 100 mg in one of three study periods. There will be at least 10 days between each study period.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Aliskiren | 2-5 hours post dose of study drug |
Secondary
| Measure | Time frame |
|---|---|
| change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Losartan | 2-5 hours post dose of study drug |
Outcome results
None listed