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

Velicept Therapeutics, Inc.0 sites24 target enrollmentOctober 2016

ConditionsHealthy Subjects, Overactive Bladder

InterventionsFormulation 1 solabegron Formulation 2 solabegron

DrugsFormulation 1 solabegron Formulation 2 solabegron

Overview

Phase: Phase 1
Intervention: Formulation 1 solabegron
Conditions: Healthy Subjects, Overactive Bladder
Sponsor: Velicept Therapeutics, Inc.
Enrollment: 24
Primary Endpoint: Maximum observed plasma drug concentration (Cmax)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2016

End Date

December 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Velicept Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility 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)