Trial | NCT02938507  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    solabegron ...

  • Study Participants

    24
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of different 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. 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 Started
Oct 31
2016
Primary Completion
Dec 31
2016
Study Completion
Dec 31
2016
Last Update
Apr 24
2019

Drug Formulation 1 solabegron

Drug Formulation 2 solabegron

Formulation 1 solabegron Experimental

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

Formulation 2 solabegron Experimental

Subjects will receive formulation 2 in a single-blind, randomized, cross-over fashion in Periods 1 to 3.

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)
No Results Posted