Compare the Pharmacokinetics of Omeprazole, Rosiglitazone, and Desipramine When Administered With Avanafil in Healthy Male Subjects

NCT01415128 | Completed Phase 1

• 1 other identifier: TA-018
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• To measure a composite of pharmacokinetic parameters of Omeprazole, Rosiglitazone and Desipramine.

  AUC0-t, AUC0-inf, Cmax, tmax, half-life

  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

  In the morning at Screening, Days 1-8 and upon early termination

Study Arms (3)

Omeprazole

ACTIVE COMPARATOR

Omeprazole with single dose of avanafil (200 mg)

Drug: Omeprazole

Rosiglitazone

ACTIVE COMPARATOR

Rosiglitazone with single dose of avanafil (200 mg)

Drug: Rosiglitazone

Desipramine

ACTIVE COMPARATOR

Desipramine with single dose of avanafil (200 mg)

Drug: Desipramine

Interventions

Omeprazole DRUG

Once a day dosing of Omeprazole (40 mg) for 8 days

Omeprazole

Rosiglitazone DRUG

Single dose of Rosiglitazone (8 mg) for 1 day

Rosiglitazone

Desipramine DRUG

Single dose of Desipramine (50 mg) for 1 day

Desipramine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• VIVUS LLC: lead

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Omeprazole; Rosiglitazone; Desipramine

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiazolidinediones; Thiazoles; Azoles; Dibenzazepines; Heterocyclic Compounds, 3-Ring

Study Officials

• Shiyin Yee

  VIVUS LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 28, 2010
• First Posted: August 11, 2011
• Study Start: April 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 11, 2011

Record last verified: 2011-08