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

NCT00427596 | Completed Phase 1

• 1 other identifier: B3A106044
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overactive Bladder

Keywords

GW427353 oral tablets,; healthy adult subjects,; food effect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

Interventions

Solabegron DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Buffalo, New York, 14209, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

solabegron

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials, MD, MSc

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 25, 2007
• First Posted: January 29, 2007
• Study Start: January 1, 2007
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: October 7, 2008

Record last verified: 2008-10

Locations

US (1)