A Two-Part Study to Determine: Best Medication Formulation and Food Effect
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|ClinicalTrials.gov Identifier: NCT00427596|
Recruitment Status : Completed
First Posted : January 29, 2007
Last Update Posted : October 7, 2008
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder||Drug: Solabegron||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Two-Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Four MR Formulations and Food Effect of GW427353 (Solabegron) in Healthy Adult Subjects|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||August 2007|
- Absorption rate of the tablet formulations as measured several times by blood draws (over 48-hour period) during the Part 1 under fed conditions and Part 2 under fed vs. fasted conditions
- Toleration of the formulations after single and repeat doses (over 7-day period)
- Part 1: Safety and tolerability assessments will include data from spontaneous adverse event reporting, vital signs, 12-lead ECGs, physical examinations, and safety laboratory tests.
- Part 2: Safety and tolerability assessments will include data from spontaneous adverse event reporting, vital signs, 12-lead ECGs, physical examinations, and safety laboratory tests.
- Part 2: The secondary pharmacokinetic parameters will be the AUC, Cmax, Tmax, and T1/2 following repeat oral dosing of Solabegron, as the data permit.
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): NCT00427596
|United States, New York|
|GSK Investigational Site|
|Buffalo, New York, United States, 14209|
|Study Director:||GSK Clinical Trials, MD, MSc||GlaxoSmithKline|