Erectile Dysfunction Clinical Trial
Official title:
A PHASE I, SINGLE-CENTER, OPEN-LABEL, CROSSOVER STUDY OF THE EFFECT OF AVANAFIL ON THE PHARMACOKINETICS OF OMEPRAZOLE, DESIPRAMINE AND ROSIGLITAZONE IN HEALTHY MALE SUBJECTS
This study will compare the pharmacokinetics of omeprazole, rosiglitazone and desipramine when administered with a single oral dose of avanafil in healthy male subjects.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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