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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Overactive Bladder

Treatments

Drug: Solabegron

Study type

Interventional

Funder types

Industry

Identifiers

NCT00427596

B3A106044

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.