RenalPhase 1NCT01054261

To Compare the Pharmacokinetics of Avanafil in Subjects With Mild and Moderate Renal Impairment to Subjects With Normal Renal Function.

A Phase 1 study testing avanafil in people with Renal, run by VIVUS LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of this study is to compare the pharmacokinetics of avanafil in subjects with mild and moderate renal impairment and to assess the safety and toleration of avanafil in subjects with mild and moderate renal impairment. Read more about this study

Who is it for?: Ages 21 to 78 years, men onlyHealthy volunteers can take part
Conditions the study is for: Renal
What is being tested?: avanafil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: No sites listed yet
Study dates: Jan 2010to Feb 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 21 to 78 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adult male subjects,
21-78 years of age, must be medically healthy with no clinically significant screening results (except for the subjects in Groups 2 and 3).
Subjects with normal renal function (Group 1) must have an estimated CLcr of ≥80 mL/min.
Subjects with renal impairment (Groups 2 and 3) must fulfill the additional following criteria: (a) Stable renal impairment; (b) Group 2 subjects with mild renal impairment must have a CLcr of ≥50 to <80 mL/min and (c) Group 3 subjects with moderate renal impairment must have a CLcr of ≥30 to <50 mL/min.

Who cannot join

Major exclusion criteria include: history or clinical evidence of clinically relevant cardiovascular (including thromboembolic disorders), hepatic, renal (with the exception of renal insufficiency for subjects in Groups 2 and 3), hematological, endocrine, pulmonary, gastrointestinal, psychiatric or neurological impairment; any clinically significant laboratory abnormalities as judged by the Investigator; systolic blood pressure < 90 or >160 mmHg; diastolic blood pressure < 50 or > 95 mmHg; allergy to or previous adverse events with PDE5 inhibitors or its constituents; use of prescription or over-the-counter drugs that are known to interfere with metabolism by the cytochrome P450 3A4 enzyme within 30 days prior to Day 1; use of any investigational drug within 30 days prior to Day 1; use of any prescription or over-the-counter drugs or herbal remedies within 14 days prior to Day 1; history of alcohol or drug abuse within 18 months, history of smoking within 6 months; positive breathe alcohol test; positive cotinine test, positive urine drug screen (except in renally impaired subjects following approval by Sponsor). Additional exclusion criteria are listed in Section 4.2.

About this study

Official title: A Phase I, Open-Label, Parallel-Group, Single Dose, Non-Randomized Study to Compare the Pharmacokinetics of Avanafil in Male Subjects With Mild and Moderate Renal Impairment to Subjects With Normal Renal Function

Conditions: Renal
Being tested: avanafil
Keywords: avanafil, renal, impairment, TA-1790

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

avanafilDrug
200 mg avanafil tablet QD

Study groups in NCT01054261
Study group	Role	What they receive
Normal	Other	Normal renal function Receives: Drug: avanafil
Mild	Other	Mild renal impairment Receives: Drug: avanafil
Moderate	Other	Moderate renal impairment Receives: Drug: avanafil

What is being measured

The primary outcome is the main question the study is designed to answer.

Single dose PK of avanafil
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Feb 2010

First posted22 Jan 2010 (estimated)
Study startJan 2010
Primary completionFeb 2010
Study completionFeb 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for RenalStudies 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: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01054261
Sponsor's protocol ID: TA-013
Status last verified: Jan 2011
First submitted: 20 Jan 2010
Last updated: 7 Jan 2011
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1/2
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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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All Renal trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open-Label, Parallel-Group, Single Dose, Non-Randomized Study to Compare the Pharmacokinetics of Avanafil in Male Subjects With Mild and Moderate Renal Impairment to Subjects With Normal Renal Function
ClinicalTrials.gov ID: NCT01054261
Acronym / sponsor ID: TA-013
Conditions: Renal
Keywords: avanafil, renal, impairment, TA-1790
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: VIVUS LLCIndustry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Feb 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 22 Jan 2010 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Normal	Other	Drug: avanafilNormal renal function
Mild	Other	Drug: avanafilMild renal impairment
Moderate	Other	Drug: avanafilModerate renal impairment

Who may qualify

Ages: 21 to 78 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Adult male subjects,
21-78 years of age, must be medically healthy with no clinically significant screening results (except for the subjects in Groups 2 and 3).
Subjects with normal renal function (Group 1) must have an estimated CLcr of ≥80 mL/min.
Subjects with renal impairment (Groups 2 and 3) must fulfill the additional following criteria: (a) Stable renal impairment; (b) Group 2 subjects with mild renal impairment must have a CLcr of ≥50 to <80 mL/min and (c) Group 3 subjects with moderate renal impairment must have a CLcr of ≥30 to <50 mL/min.

Key exclusion criteria (1 listed)

Major exclusion criteria include: history or clinical evidence of clinically relevant cardiovascular (including thromboembolic disorders), hepatic, renal (with the exception of renal insufficiency for subjects in Groups 2 and 3), hematological, endocrine, pulmonary, gastrointestinal, psychiatric or neurological impairment; any clinically significant laboratory abnormalities as judged by the Investigator; systolic blood pressure < 90 or >160 mmHg; diastolic blood pressure < 50 or > 95 mmHg; allergy to or previous adverse events with PDE5 inhibitors or its constituents; use of prescription or over-the-counter drugs that are known to interfere with metabolism by the cytochrome P450 3A4 enzyme within 30 days prior to Day 1; use of any investigational drug within 30 days prior to Day 1; use of any prescription or over-the-counter drugs or herbal remedies within 14 days prior to Day 1; history of alcohol or drug abuse within 18 months, history of smoking within 6 months; positive breathe alcohol test; positive cotinine test, positive urine drug screen (except in renally impaired subjects following approval by Sponsor). Additional exclusion criteria are listed in Section 4.2.

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
avanafil200 mg avanafil tablet QD	Drug	Mild, Moderate, Normal

Primary outcome

Single dose PK of avanafil
Time frame: 1 day

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 7 Jan 2011.

Related trials for Renal

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease

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 avanafil in people with Renal, 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 4 inclusion and 1 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 7 Jan 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?

Single dose PK of avanafil (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01054261.

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 7 Jan 2011.