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

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ClinicalTrials.gov Identifier: NCT02938507
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Velicept Therapeutics, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Subjects, Overactive Bladder Drug: Formulation 1 solabegron Drug: Formulation 2 solabegron Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : October 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Formulation 1 solabegron
Subjects will receive formulation 1 solabegron doses in a single-blind, randomized, cross-over fashion in Periods 1 to 3.
Drug: Formulation 1 solabegron
Experimental: Formulation 2 solabegron
Subjects will receive formulation 2 in a single-blind, randomized, cross-over fashion in Periods 1 to 3.
Drug: Formulation 2 solabegron



Primary Outcome Measures :
  1. Maximum observed plasma drug concentration (Cmax) [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938507


Sponsors and Collaborators
Velicept Therapeutics, Inc.
Investigators
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Study Director: Eliot Ohlstein, PhD Velicept Therapeutics, Inc.

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Responsible Party: Velicept Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02938507     History of Changes
Other Study ID Numbers: VEL-1001
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Velicept Therapeutics, Inc.:
Overactive bladder, Incontinence

Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solabegron
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs