A Pharmacokinetic Study of Avanfil in Healthy Young Male... | NCT00914511

Studies
A Pharmacokinetic Study of Avanfil in Healthy Young Male Subjects

NCT00914511

Sponsor

VIVUS LLC

Status

Completed

Last Update Posted

Jan 7, 2011Estimated

Enrollment

32Actual

Phase

Phase 1

Conditions

Avanfil ADME
Semen Exposure
Sperm Function

Interventions

avanafil 200mg
avanafil 200mg

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Jun 3, 2009

First Submission Date that Met QC Criteria

Jun 4, 2009

First Posted Date

Jun 5, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2011

Last Update Posted Date

Jan 7, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purposes of this study are to:

Determine the effect of the study drug on sperm and semen of healthy young male subjects.
Determine the effect of age on the amount of study drug in the blood of healthy subjects
Learn about the safety of the study drug.
Learn how subjects tolerate the study drug.

Detailed Description

This single-center, open-label, non-randomized, two-cohort, single-dose pharmacokinetic study will be conducted at a single site in the United States, in which at least 18 young (18-45 years, inclusive) male subjects in Cohort A and 14 elderly (65 years or older) males in Cohort B will be enrolled and dosed to achieve a total of at least 14 completed young subjects and 12 elderly subjects. Seminal fluid and plasma will be collected from Cohort A, whereas only plasma samples will be collected from Cohort B.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy young males	Experimental	Healthy young males age 18-45, inclusive	Drug: avanafil 200mg
Elderly males	Experimental	Elderly males 65 years of age and older	Drug: avanafil 200mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
avanafil 200mg	Drug	single dose tablet of 200mg avanafil	Healthy young males

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma pharmacokinetic parameters of avanafil and its metabolites will be evaluated including AUC (0-t), AUC(0-inf), Cmax, fu, t1/2, and tmax; Sperm motility, function and morphology; Avanafil exposure in seminal fluid		pre-dose (baseline) through 24 hours post-dose

Secondary Outcomes

Measure	Description	Time Frame
adverse events (each study visit); laboratory evaluations; electrocardiogram and physical examination; vital signs will be assessed at various times during the study.		pre-dose (baseline) through 24 hours post-dose

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cohort A: Adult male subjects of 18 to 45 years of age inclusive Cohort B: Adult male subjects at least 65 years of age
All subjects must be medically healthy with no clinically significant screening results.
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.

Exclusion Criteria:

Major exclusion criteria for all subjects include:

History or clinical evidence of clinically relevant cardiovascular (including thromboembolic disorders), hepatic, renal, hematologic, endocrine, pulmonary, gastrointestinal, psychiatric or neurological impairment
Any clinically significant laboratory abnormalities as judged by the investigator
Systolic blood pressure < 90 or >150 mmHg
Diastolic blood pressure < 50 or > 95 mmHg
Allergy to or previous adverse events with PDE5 inhibitors
Use of prescription or over-the-counter drugs that are known to interfere with metabolism by the cytochrome P450 3A4 enzyme within 30 days of screening
Use of any investigational drug within 30 days of screening
Use of any prescription or over-the-counter drugs or herbal remedies within 14 days of screening
History of alcohol or drug abuse within 18 months, history of smoking within 6 months
Positive urine alcohol test
Positive urine drug screen
Positive urine cotinine test, positive serology for HIV, HCV, HBsAg
Young males who have undergone vasectomy cannot participate in this-study
Additional exclusion criteria are listed in Section 4.2.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided