Erectile DysfunctionPhase 1NCT01415128
Compare the Pharmacokinetics of Omeprazole, Rosiglitazone, and Desipramine When Administered With Avanafil in Healthy Male Subjects
A Phase 1 study testing Omeprazole, Rosiglitazone and Desipramine in people with Erectile Dysfunction, run by VIVUS LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Omeprazole, Rosiglitazone and Desipramine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to May 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntarily consent to participate in the study (informed consent form must be signed and dated prior to any study related assessments).
- Adult male subjects of 18 to 45 years of age inclusive.
- A body weight of at least 50 kg and a body mass index (BMI) between 18 and 30 kg/m2, inclusive [BMI will be calculated as weight in kg/(height in m)2].
- Subjects must be identified as CYP2D6 extensive metabolizers (determined by genotyping) for Cohort C only
- Subjects are able to communicate with the investigator, and to understand and comply with all requirements of study participation.
- Medically healthy, with no clinically significant screening results (e.g., laboratory profiles, medical histories, ECGs, physical exam, etc.), in the opinion of the investigator in consultation with the Sponsor.
- Male subjects should be willing to use a condom and spermicide during sexual activity for 90 days after last dosing of avanafil and be willing to not donate sperm for 90 days after dosing.
Who cannot join
- A history or presence of significant cardiovascular (including thromboembolic disorders), neurological, hematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs or place the subjects at increased risk as determined by the investigator.
- Any clinically significant laboratory abnormalities as judged by the investigator. Inclusion of a subject with out of normal range laboratory values must be approved by VIVUS prior to subject enrollment.
- A predisposition to priapism, such as subjects with sickle cell disease or blood dyscrasias.
- Known history of cardiovascular or cerebrovascular event, any history of angina.
- History or ECG evidence of any high-risk arrhythmia or ECG judged by the investigator to be clinically significant.
- Hypertrophic obstructive or other clinically significant cardiomyopathy, moderate or severe cardiac valvular disease.
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- Subjects whose pulse is lower than 50 bpm at screening or 50 bpm prior to dosing for period 1 only.
- Acute illness, especially any infection, within 2 weeks of dosing.
- Systolic blood pressure < 90 or > 140 mmHg; diastolic blood pressure < 60 or > 95 mmHg at screening or on Day -1 (2 rechecks are allowed) for period 1 only.
- History of retinitis pigmentosa or nonarteritic anterior ischemic optic neuropathy.
- Hemoglobin < 12.0 g/dL.
- Subjects with liver function tests > 1.5 ULN
- Positive urine drug test and/or positive urine alcohol test at screening or on Day -1.
- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV) at screening.
- Any history or presence of alcoholism or drug or substance abuse within 18 months or as defined by the investigator.
- Allergy to or previously significant adverse events with PDE5 inhibitors, omeprzole, rosiglitazone and desipramine or their constituents.
- Use of any prescription or over-the-counter (OTC) medication, including herbal products, within the 30 days prior to Day 1. Up to 2 g per day of acetaminophen is allowed at the discretion of the Investigator.
- Use of any drug in Appendix 1 (drugs known to have clinical significance in inhibiting or inducing liver enzymes involved in drug metabolism [CYP P450]) within 30 days prior to Day 1.
- Blood donation or significant blood loss within 56 days prior to Day 1.
- Plasma donation within 14 days prior to Day 1.
- Any use of tobacco or nicotine products within 6 months prior to Day 1.
- Any subject who received an investigational drug within 30 days or six half-lives, whichever is longer, prior to Day 1.
- Evidence of any clinically significant medical, psychiatric, social or other condition by history, physical examination or laboratory studies that, in the opinion of the investigator, would contraindicate the administration of study medications, affect compliance, interfere with study evaluations, limit study participation, or confound the interpretation of study results.
- Involvement in the planning and conduct of the study (applies to both VIVUS or designee staff, or staff at the investigational site).
About this study
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.
Read the 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.
- Conditions
- Erectile Dysfunction
- Being tested
- Omeprazole, Rosiglitazone, Desipramine
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
Once a day dosing of Omeprazole (40 mg) for 8 days
RosiglitazoneDrug
Single dose of Rosiglitazone (8 mg) for 1 day
DesipramineDrug
Single dose of Desipramine (50 mg) for 1 day
| Study group | Role | What they receive |
|---|---|---|
| Omeprazole | Active comparator | Omeprazole with single dose of avanafil (200 mg) Receives: Drug: Omeprazole |
| Rosiglitazone | Active comparator | Rosiglitazone with single dose of avanafil (200 mg) Receives: Drug: Rosiglitazone |
| Desipramine | Active comparator | Desipramine with single dose of avanafil (200 mg) Receives: Drug: Desipramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure a composite of pharmacokinetic parameters of Omeprazole, Rosiglitazone and Desipramine.
AUC0-t, AUC0-inf, Cmax, tmax, half-life
Measured: 0, 20, 40 minutes and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 hours post dose
Secondary outcomes (1)
To assess vital signs before, during and after dosing
heart rate and blood pressure
Measured: In the morning at Screening, Days 1-8 and upon early termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startApr 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIVUS LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shiyin Yee, Study director, VIVUS LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415128
- Sponsor's protocol ID
- TA-018
- Status last verified
- Aug 2011
- First submitted
- 28 Mar 2010
- Last updated
- 11 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01415128
- Acronym / sponsor ID
- TA-018
- Conditions
- Erectile Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- VIVUS LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 11 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Omeprazole | Active comparator | Drug: OmeprazoleOmeprazole with single dose of avanafil (200 mg) |
| Rosiglitazone | Active comparator | Drug: RosiglitazoneRosiglitazone with single dose of avanafil (200 mg) |
| Desipramine | Active comparator | Drug: DesipramineDesipramine with single dose of avanafil (200 mg) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Voluntarily consent to participate in the study (informed consent form must be signed and dated prior to any study related assessments).
- Adult male subjects of 18 to 45 years of age inclusive.
- A body weight of at least 50 kg and a body mass index (BMI) between 18 and 30 kg/m2, inclusive [BMI will be calculated as weight in kg/(height in m)2].
- Subjects must be identified as CYP2D6 extensive metabolizers (determined by genotyping) for Cohort C only
- Subjects are able to communicate with the investigator, and to understand and comply with all requirements of study participation.
Key exclusion criteria (24 listed)
- A history or presence of significant cardiovascular (including thromboembolic disorders), neurological, hematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs or place the subjects at increased risk as determined by the investigator.
- Any clinically significant laboratory abnormalities as judged by the investigator. Inclusion of a subject with out of normal range laboratory values must be approved by VIVUS prior to subject enrollment.
- A predisposition to priapism, such as subjects with sickle cell disease or blood dyscrasias.
- Known history of cardiovascular or cerebrovascular event, any history of angina.
- History or ECG evidence of any high-risk arrhythmia or ECG judged by the investigator to be clinically significant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmeprazoleOnce a day dosing of Omeprazole (40 mg) for 8 days | Drug | Omeprazole |
| RosiglitazoneSingle dose of Rosiglitazone (8 mg) for 1 day | Drug | Rosiglitazone |
| DesipramineSingle dose of Desipramine (50 mg) for 1 day | Drug | Desipramine |
Primary outcome
To measure a composite of pharmacokinetic parameters of Omeprazole, Rosiglitazone and Desipramine.
Time frame: 0, 20, 40 minutes and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 hours post dose
AUC0-t, AUC0-inf, Cmax, tmax, half-life
1 secondary outcome
To assess vital signs before, during and after dosing
Time frame: In the morning at Screening, Days 1-8 and upon early termination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiyin Yee study director
VIVUS LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omeprazole, Rosiglitazone and Desipramine in people with Erectile Dysfunction, run by VIVUS LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure a composite of pharmacokinetic parameters of Omeprazole, Rosiglitazone and Desipramine. (time frame: 0, 20, 40 minutes and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 hours post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2011.