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

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

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: Solabegron

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14209
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, MD, MSc, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): August 1, 2007
• Study Completion (Actual): August 1, 2007

Study Registration Dates

• First Submitted: January 25, 2007
• First Submitted That Met QC Criteria: January 25, 2007
• First Posted (Estimate): January 29, 2007

Study Record Updates

• Last Update Posted (Estimate): October 7, 2008
• Last Update Submitted That Met QC Criteria: October 6, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: food effect; GW427353 oral tablets,; healthy adult subjects,
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic Agonists; Adrenergic beta-Agonists; Adrenergic beta-3 Receptor Agonists; Solabegron
• Other Study ID Numbers: B3A106044