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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solabegron
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 14, 2014