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

Phase 1

Completed

• Conditions: Healthy Subjects, Overactive Bladder
• Interventions: Drug: Formulation 1 solabegron; Drug: Formulation 2 solabegron

• Registration Number: NCT02938507
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-19
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-23
• Last Update Posted: 2019-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Formulation 1 solabegron	Formulation 1 solabegron	Subjects will receive formulation 1 solabegron doses in a single-blind, randomized, cross-over fashion in Periods 1 to 3.
Formulation 2 solabegron	Formulation 2 solabegron	Subjects will receive formulation 2 in a single-blind, randomized, cross-over fashion in Periods 1 to 3.

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma drug concentration (Cmax)	24 hours