A Two-Part Study to Determine: Best Medication Formulation and Food Effect

Overactive Bladder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00427596
• Other study ID #: B3A106044
• Status: Completed
• Phase: Phase 1
• First received: January 25, 2007
• Last updated: October 6, 2008
• Start date: January 2007
• Est. completion date: August 2007

Study information

• Verified date: October 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

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 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Solabegron

Locations

Country	Name	City	State
United States	GSK Investigational Site	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Toleration of the formulations after single and repeat doses (over 7-day period)
Secondary	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.
Secondary	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.
Secondary	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.