Study To Investigate The Hemodynamic Effects Of Single Dose Vardenafil In Subjects Receiving Maraviroc

Study Overview
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Brief Summary
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The objective of this study was to estimate the effects of a single dose of vardenafil on the blood pressure (BP) in subjects receiving maraviroc (MVC) (dosed to steady-state) and to assess the safety and tolerability of MVC in subjects receiving a single dose of vardenafil.

Official Title
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A Randomized, Single-Blinded, Placebo-Controlled Two-Way Crossover Study To Investigate The Hemodynamic Effects Of Single Dose Vardenafil In Subjects Receiving Maraviroc

Conditions
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AIDS

Intervention / Treatment
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* Drug: Maraviroc
* Drug: Vardenafil
* Drug: Maraviroc
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects. no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead electrocardiogram and clinical laboratory tests. Body mass index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs). Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. Subjects with a supine systolic BP of greater than 140 mm Hg, or a supine diastolic BP of greater than 90 mm Hg, either at Screening or at the predose measurements.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.<br>Maraviroc + Vardenafil | Drug: Maraviroc<br>* Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Vardenafil 20 mg.<br>* Other names: Celsentri, Selzentry;Drug: Vardenafil<br>* Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Vardenafil 20 mg.<br>|
| Placebo Comparator: 2.<br>Maraviroc + Placebo | Drug: Maraviroc<br>* Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Placebo.<br>* Other names: Selzentry, Celsentri;Drug: Placebo<br>* Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standing and Supine Systolic and Diastolic Blood Pressure (BP) | Supine BP was taken after subjects rested for 5 minutes supine. Subjects then sat for 2 minutes and stood for 2 minutes then standing BP taken. Duplicate supine and standing BP measurements were taken per the protocol. The average of the duplicate measurements was calculated prior to data analysis. | 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standing and Supine Pulse Rate | Supine pulse rate measurement was taken after subject rested for 5 minutes supine. Subject sat for 2 minutes, then stood for 2 minutes and standing measurement taken. Duplicate supine and standing pulse rate measurements taken per protocol. Average of duplicate measurements calculated prior to data analysis. | 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose | 
| Postural Changes in Systolic and Diastolic Blood Pressure | Postural change calculated as position 1 (standing) value minus the position 2 (supine) value. Baseline was the average of 3 predose measurements at each period. Means of replicates were used in calculations. | Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg | 
| Postural Changes in Pulse Rate | Postural change calculated as position 1 (standing) value minus position 2 (supine) value. Baseline was the average of the 3 predose measurements at each period. Means of Replicates were used in calculations. | Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg | 
| Number of Subjects With Postural Hypotension | Postural (orthostatic) hypotension defined as 1) decrease in standing-supine diastolic blood pressure (BP) greater than or equal to 10 mm Hg; 2) decrease in standing-supine systolic BP greater than or equal to 20 mm Hg; or 3) standing systolic BP less than 90 mm Hg. Assessed at Period 1 and Period 2 BP measurement timepoints post maraviroc dose. | Period 1 and Period 2 (up to 8 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacodynamics. maraviroc, vardenafil, blood pressure