Clinical trial NCT00427596: A Two-Part Study to Determine: Best Medication Formulation and Food Effect
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overactive Bladder
Keywords: GW427353 oral tablets,
healthy adult subjects,
food effect
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-01-29
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
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 outcomes:
measure: Toleration of the formulations after single and repeat doses (over 7-day period)
measure: 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.
measure: 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.
measure: 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.
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: GSK Investigational Site
state: New York
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD, MSc
role: STUDY_DIRECTOR
References: