Compare the Pharmacokinetics of Omeprazole, Rosiglitazone, and Desipramine When Administered With Avanafil in Healthy Male Subjects
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the pharmacokinetics of omeprazole, rosiglitazone and desipramine
      when administered with a single oral dose of avanafil in healthy male subjects.
    

Detailed description: 
      There will be three cohorts in this Phase I, single-center, open-label, crossover study:

      Cohort A (omeprazole): This is a open-label, non-randomized, one-sequence crossover study
      design, in which 20 healthy male subjects will be enrolled and administered a single oral
      dose of 40 mg omeprazole once daily for 8 days (Days 1-8) plus a single oral dose of 200 mg
      avanafil on Day 8. On Days 7 and 8, avanafil and/or omeprazole doses will be administered
      following an overnight fast of at least 10 hours.

      All subjects will be confined at the Clinical Research Unit the day prior to the omeprazole
      administration on Day 7 and will remain confined for approximately 13 hours following the
      dosing on Day 8. Blood samples for determination of plasma omeprazole concentrations will be
      obtained from all subjects at 0 (10 minutes pre-dose), 20, 40 minutes and 1, 1.5, 2, 2.5, 3,
      4, 6, 8, 10 and 12 hours post-dose on Days 7 and 8. Pre-dose blood samples for determination
      of omeprazole will also be taken in the morning on Days 5-6.

      Cohort B (rosiglitazone): This is a randomized, open-label, two-period crossover study
      design, in which 20 male subjects will be randomized to receive the following treatments:

        -  Treatment A: a single oral dose of 8 mg rosiglitazone following an overnight fast of at
           least 10 hours.

        -  Treatment B: a single oral dose of 8 mg rosiglitazone plus a single oral dose of 200 mg
           avanafil following an overnight fast of at least 10 hours.

      The two treatments in the cohort will be separated by a washout period of at least 7 days.
      All subjects will be confined at the Clinical Research Unit approximately from the morning of
      Day -1 to the morning of Day 2 in both treatment periods. Blood samples for determination of
      plasma rosiglitazone concentrations will be obtained from all subjects at 0 (10 minutes
      pre-dose) and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 16 and 24 hours post-dose.

      Cohort C (desipramine): This is a randomized, open-label, two-period, crossover study design,
      in which 20subjects identified as CYP2D6 extensive metabolizers (determined by genotyping)
      will be randomized to receive the following treatments:

        -  Treatment A: a single oral dose of 50 mg desipramine following an overnight fast of at
           least 10 hours.

        -  Treatment B: a single oral dose of 50 mg desipramine plus a single oral dose of 200 mg
           avanafil following an overnight fast of at least 10 hours. The avanafil dose will be
           administered 2 hours after the desipramine administration.

      The two treatments in the cohort will be separated by a washout period of at least 10 days.
      All subjects will be confined at the Clinical Research Unit from the morning of Day -1 to the
      morning of Day 2 in both treatment periods. Blood samples for determination of plasma
      desipramine concentrations will be obtained from all subjects at 0 (10 minutes pre-dose) and
      1, 2, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours post-dose. Subjects will visit the study site
      as outpatients in the morning for their remaining PK blood sample collection on Days 3-5.
    

Intervention name(s): Omeprazole; Rosiglitazone; Desipramine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Once a day dosing of Omeprazole (40 mg) for 8 days; Single dose of Rosiglitazone (8 mg) for 1 day; Single dose of Desipramine (50 mg) for 1 day
Intervention MeSH terms: Rosiglitazone; Desipramine; Omeprazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment