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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00427596
First received: January 25, 2007
Last updated: October 6, 2008
Last verified: October 2008
  Purpose

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.


Condition Intervention Phase
Overactive Bladder
Drug: Solabegron
Phase 1

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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.

Enrollment: 18
Study Start Date: January 2007
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Solabegron
    Other Name: Solabegron
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427596

Locations
United States, New York
GSK Investigational Site
Buffalo, New York, United States, 14209
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD, MSc GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00427596     History of Changes
Other Study ID Numbers: B3A106044
Study First Received: January 25, 2007
Last Updated: October 6, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
GW427353 oral tablets,
healthy adult subjects,
food effect

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014