Erectile Dysfunction Clinical Trial
Official title:
A Phase I, Single-Centre, Open-Label, Randomized, One-sequence Crossover, Three-Group Study to Evaluate the Effect of Ketoconazole, Ritonavir and Erythromicin on the Safety and Pharmacokinetics of Avanafil (TA-1790) in Healthy Male Subjects
Verified date | November 2009 |
Source | VIVUS, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study is being conducted to examine the effect of three CYP3A4 inhibitors (ketoconazole, erythromycin and ritonavir) on the single dose pharmacokinetics of avanafil. Ketoconazole and ritonavir are potent inhibitors of CYP3A4 and erythromycin is a moderate CYP3A4 inhibitor. Any interaction that is observed would be predictive of other inhibitors of CYP3A4.
Status | Completed |
Enrollment | 44 |
Est. completion date | December 2008 |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 21 Years to 45 Years |
Eligibility |
Inclusion Criteria: 1. Males, 21 to 45 years of age (inclusive). 2. A body weight of at least 50 kg and a body mass index (BMI) between 21 and 28 kg/m2, inclusive 3. Medically healthy, with clinically insignificant screening results [e.g., laboratory profiles, medical histories, ECGs, physical exam, etc., in the opinion of the investigator. 4. Subjects are able to communicate with the investigator, and to understand and comply with all requirements of study participation. 5. Voluntarily consent to participate in the study 6. The subject must agree not to donate his sperm during and within 3-months of the completion of the study. 7. All sexually active male subjects and their female partners of childbearing potential must agree to use adequate contraception methods, for the specified time. Exclusion Criteria: 1. A history or presence of significant cardiovascular, 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. 2. Any clinically significant laboratory abnormalities as judged by the investigator. 3. Systolic blood pressure < 90 or >140 mmHg; diastolic blood pressure < 50 or > 90 mmHg at screening or at check-in on day 1 in treatment period 1. 4. Positive urine drug test and/or positive breath alcohol test. 5. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV) at screening. 6. Any history or presence of alcoholism or drug or substance abuse. 7. Allergy to or previous adverse events with PDE5 inhibitors, ketoconazole, ritonavir and/or erythromycin or their constituents. 8. Use of any prescription or over-the-counter (OTC) medication, including herbal products. 9. Use of any drugs known to have clinical significance in inhibiting or inducing liver enzymes involved in drug metabolism 10. Blood donation or significant blood loss. 11. Any use of tobacco or nicotine products within 6 months. 12. Any history of celiac diseases, food allergies, and those on vegetarian or other diets incompatible with study objectives. 13. Any subject who received an investigational drug within 30 days . 14. Clinical judgment by the investigator that the subject should not participate in the study. |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Research Site | Lincoln | Nebraska |
Lead Sponsor | Collaborator |
---|---|
VIVUS, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the safety of avanafil when administered with Ketoconazole, ritonavir, or erythromycin and to assess the effect of co-administration of these drugs on the pharmacokinetics of avanafil | 9 days | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05366504 -
LiST Plus PRP Injection Therapy vs LiST Monotherapy for ED Treatment
|
Phase 2/Phase 3 | |
Recruiting |
NCT02745808 -
Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes
|
Phase 1 | |
Recruiting |
NCT02573805 -
the Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males
|
N/A | |
Withdrawn |
NCT01967251 -
Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction
|
Phase 2 | |
Withdrawn |
NCT02579148 -
Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes
|
Phase 1 | |
Recruiting |
NCT02225548 -
Sagene 2014 - Parkinson's Disease and Erectile Dysfunction
|
Phase 4 | |
Completed |
NCT02587988 -
Trial to Evaluate the Efficacy and Safety of HCP1302
|
Phase 3 | |
Completed |
NCT01937871 -
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED)
|
Phase 3 | |
Completed |
NCT02945462 -
Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED)
|
Phase 1 | |
Completed |
NCT01698684 -
Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction
|
Phase 4 | |
Not yet recruiting |
NCT01321489 -
A Study to Evaluate a Possible Superiority Expressed by the Faster Onset of Action and the Efficacy and Safety of Sildenafil Citrate 20mg Sublingual Tablet in the Treatment of Erectile Dysfunction of Different Etiologies
|
Phase 3 | |
Completed |
NCT02226237 -
Effectiveness of Physiotherapy to Treat the Urinary Incontinence and Erectile Dysfunction Post Retropubic Prostatectomy
|
N/A | |
Terminated |
NCT01262833 -
Pudendal Assessment in Erectile Dysfunction
|
N/A | |
Completed |
NCT01230541 -
Effect of Udenafil on Spermatogenesis
|
Phase 1 | |
Completed |
NCT01037244 -
Treatment of Erectile Dysfunction I
|
Phase 3 | |
Completed |
NCT01037218 -
Treatment of Erectile Dysfunction II
|
Phase 3 | |
Recruiting |
NCT00313898 -
Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males
|
Phase 4 | |
Completed |
NCT00421083 -
Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury
|
Phase 3 | |
Completed |
NCT00667979 -
Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse
|
Phase 4 | |
Completed |
NCT00663728 -
Assessment of Duration of Erection With Vardenafil 10 mg
|
Phase 4 |