Healthy Subjects, Overactive BladderPhase 1NCT02938507

Evaluate the Safety, Tolerability and PK of Different Formulations of Orally Administered Solabegron in Healthy Male Subjects

A Phase 1 study testing Formulation 1 solabegron and Formulation 2 solabegron in people with Healthy Subjects, Overactive Bladder, run by Velicept Therapeutics, Inc..

Completed

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

Official record

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Trial summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of different formulations of orally administered solabegron in healthy male subjects. Read more about this study

Who is it for?: Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Subjects, Overactive Bladder
What is being tested?: Formulation 1 solabegron and Formulation 2 solabegron
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: No sites listed yet
Study dates: Oct 2016to Dec 2016
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 65 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Body weight greater than or equal to 50 kg, inclusive, and body mass index (BMI) 18.0 - 32.0 kg/m2, inclusive
In good general health as determined by a thorough medical history and physical examination, ECG, vital signs, and clinical laboratory evaluation. Results of clinical laboratory tests must be without clinically significant abnormalities, including hematology, clinical chemistry and urinalysis.
Adequate venous access to allow for repeated blood sampling
Ability to understand and comply with the study requirements
Provide written informed consent prior to any study procedure being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read).

Who cannot join

Any clinically relevant abnormality identified on the screening physical examination, clinical laboratory tests, 12-lead ECG, or any other medical condition or circumstance which would make the subject unsuitable for participation in the study based on the Investigator's assessment
Resting heart rate greater than or equal to 100 beats per minute (BPM) after 5 minutes rest (as above) at the screening visit
QTcF interval (Fredericia's correction factor) greater than 450 msec (males subjects) at screening
History of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation
History of smoking, including e-cigarettes, within 3 months of the study and/or a positive urine cotinine at screening
Regular alcohol consumption averaging ≥ 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of the first dose of study medication.
Positive urine drug or alcohol test at screening
Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study (e.g., due to expected study medication non-compliance, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures)

About this study

Official title: A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Immediate and Modified Release Formulations of Orally Administered Solabegron in Healthy Male Subjects

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of different formulations of orally administered solabegron in healthy male subjects.

Read the detailed description

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of different formulations of orally administered solabegron in healthy male subjects. Eligible male subjects will be enrolled into 2 cohorts of 12 subjects each conducted in parallel. The study is a single blind (subjects), randomized, cross-over design in 3 study periods.

Conditions: Healthy Subjects, Overactive Bladder
Being tested: Formulation 1 solabegron, Formulation 2 solabegron
Keywords: Overactive bladder, Incontinence
Medical subject headings: Urinary Bladder, Overactive

What participants receive

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

Formulation 1 solabegronDrug
Formulation 2 solabegronDrug

Study groups in NCT02938507
Study group	Role	What they receive
Formulation 1 solabegron	Experimental	Subjects will receive formulation 1 solabegron doses in a single-blind, randomized, cross-over fashion in Periods 1 to 3. Receives: Drug: Formulation 1 solabegron
Formulation 2 solabegron	Experimental	Subjects will receive formulation 2 in a single-blind, randomized, cross-over fashion in Periods 1 to 3. Receives: Drug: Formulation 2 solabegron

What is being measured

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

Maximum observed plasma drug concentration (Cmax)
Measured: 24 hours

Timeline

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

Oct 2016Dec 2016

First posted19 Oct 2016 (estimated)
Study startOct 2016
Primary completionDec 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy Subjects, Overactive BladderStudies 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: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02938507
Sponsor's protocol ID: VEL-1001
Status last verified: Apr 2019
First submitted: 12 Oct 2016
Last updated: 24 Apr 2019
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Immediate and Modified Release Formulations of Orally Administered Solabegron in Healthy Male Subjects
ClinicalTrials.gov ID: NCT02938507
Acronym / sponsor ID: VEL-1001
Conditions: Healthy Subjects, Overactive Bladder
Keywords: Overactive bladder, Incontinence
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Velicept Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2016
Primary completion: Dec 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 19 Oct 2016 (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.

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of different formulations of orally administered solabegron in healthy male subjects.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Formulation 1 solabegron	Experimental	Drug: Formulation 1 solabegronSubjects will receive formulation 1 solabegron doses in a single-blind, randomized, cross-over fashion in Periods 1 to 3.
Formulation 2 solabegron	Experimental	Drug: Formulation 2 solabegronSubjects will receive formulation 2 in a single-blind, randomized, cross-over fashion in Periods 1 to 3.

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Body weight greater than or equal to 50 kg, inclusive, and body mass index (BMI) 18.0 - 32.0 kg/m2, inclusive
In good general health as determined by a thorough medical history and physical examination, ECG, vital signs, and clinical laboratory evaluation. Results of clinical laboratory tests must be without clinically significant abnormalities, including hematology, clinical chemistry and urinalysis.
Adequate venous access to allow for repeated blood sampling
Ability to understand and comply with the study requirements
Provide written informed consent prior to any study procedure being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read).

Key exclusion criteria (8 listed)

Any clinically relevant abnormality identified on the screening physical examination, clinical laboratory tests, 12-lead ECG, or any other medical condition or circumstance which would make the subject unsuitable for participation in the study based on the Investigator's assessment
Resting heart rate greater than or equal to 100 beats per minute (BPM) after 5 minutes rest (as above) at the screening visit
QTcF interval (Fredericia's correction factor) greater than 450 msec (males subjects) at screening
History of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation
History of smoking, including e-cigarettes, within 3 months of the study and/or a positive urine cotinine at screening

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
Formulation 1 solabegron	Drug	Formulation 1 solabegron
Formulation 2 solabegron	Drug	Formulation 2 solabegron

Primary outcome

Maximum observed plasma drug concentration (Cmax)
Time frame: 24 hours

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 24 Apr 2019.
Individual participant dataSharing planned: No

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.

Eliot Ohlstein, PhD study director

Velicept Therapeutics, Inc.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Formulation 1 solabegron and Formulation 2 solabegron in people with Healthy Subjects, Overactive Bladder, run by Velicept Therapeutics, Inc..

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 5 inclusion and 8 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 24 Apr 2019. 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?

Maximum observed plasma drug concentration (Cmax) (time frame: 24 hours). 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 NCT02938507.

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 24 Apr 2019.