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

April 23, 2019 updated by: Velicept Therapeutics, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed plasma drug concentration (Cmax)
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Velicept Therapeutics, Inc.

Investigators

  • Study Director: Eliot Ohlstein, PhD, Velicept Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

October 12, 2016

First Submitted That Met QC Criteria

October 17, 2016

First Posted (Estimate)

October 19, 2016

Study Record Updates

Last Update Posted (Actual)

April 24, 2019

Last Update Submitted That Met QC Criteria

April 23, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VEL-1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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