A Two-Part Study to Determine: Best Medication Formulation and Food Effect
This study has been completed.
Information provided by:
First received: January 25, 2007
Last updated: October 6, 2008
Last verified: October 2008
This is a two-part study. Part 1 is designed to find the best modified release formulation of GW423753; Part 2 is designed to use the selected formulation(s) from Part 1 to find out if food affects the way the medication is processed by the body.
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2007 (Final data collection date for primary outcome measure)
Other Name: Solabegron
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Healthy males & females
- Part 1 ages 18-60
- Part 2 ages 18-50 & 65-80
- Within normal weight range given your height
- Negative urine drug and alcohol test
- Willing to follow all study procedures
- Any clinically relevant abnormality identified on the screening physical examination, clinical laboratory tests, 12-lead ECG, or any other medical condition or circumstance making the subject unsuitable for participation in the study based on the Investigator's assessment.
- Subjects with either a blood pressure measurement > 150/90 mmHg, or a history of coronary disease AND a blood pressure > 140/90 mmHg, at screening.
- History of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation.
- Regular alcohol consumption averaging >/7 drinks/week for women or >/ 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, alcohol or serum pregnancy test at screening and prior to dosing in each study session.
- Positive for hepatitis C antibody, hepatitis B surface antigen or HIV at screening.
- Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to administration of study medication.
- Use of prescription or non-prescription drugs within 7 days or 5 half-lives (whichever is longer) prior to administration of study medication and during the study. By exception, use of acetaminophen at doses of ≤ 2 grams per day, the use of contraceptives (oral, depots, patches, etc.) and anti-hypertensive medications will be permitted.
- Use of vitamins or herbal/dietary supplements within 7 days prior to administration of study medication and during the study.
- Subject is unable and/or unwilling to adhere to Lifestyle Guidelines
- Subjects who have donated more than 500 mL of blood or plasma within 56 days prior to administration of study medication.
- An unwillingness on the part of male volunteers to abstain from sexual intercourse with pregnant or lactating women; or an unwillingness to use a condom and another form of contraception (e.g., IUD, birth control pills taken by female partner, diaphragm with spermicide) if engaging in sexual intercourse with a woman who could become pregnant from the time of the first dose of study medication until completion of follow-up procedures.
- Pregnant or lactating woman. A pregnancy test will be performed for all women at screening and prior to each dosing session to confirm eligibility.
- The subject has a known hypersensitivity or idiosyncratic reaction to any drug chemical related to this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427596
|GSK Investigational Site
|Buffalo, New York, United States, 14209 |
||GSK Clinical Trials, MD, MSc
No publications provided
||Study Director, GSK
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 25, 2007
||October 6, 2008
||United States: Food and Drug Administration
Keywords provided by GlaxoSmithKline:
GW427353 oral tablets,
healthy adult subjects,
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 08, 2013
Urinary Bladder, Overactive
Urinary Bladder Diseases
Signs and Symptoms