NCT00501267

Brief Summary

The purpose of this study is to determine the effect of repeat doses of solabegron and oxybutynin when taken alone or together

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 13, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2007

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

2 months

First QC Date

July 13, 2007

Last Update Submit

April 14, 2015

Conditions

Overactive Bladder

Keywords

solabegron,oxybutynin,healthy adults,drug interaction

Outcome Measures

Primary Outcomes (1)

  • Absorption rate of solabegron and oxybutynin

    as measured by multiple blood draws after repeat dosing

Secondary Outcomes (1)

  • To assess bladder function

    prior to dosing Session 1 and post dose for each session

Interventions

solabegron and oxybutyninDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult males \& females ages 18-65;
  • Body weight \>50kg; BMI between 19-32;
  • Signed and dated informed consent; QTc Interval \<450 msec;

You may not qualify if:

  • Resting blood pressure \>140/90 mmHg or HR \>100 at screening;
  • History of drug allergy or other allergy which, in the opinion of the PI, contraindicates their participation;
  • Positive urine drug, alcohol or serum pregnancy test at screening and prior to dosing;
  • Positive HIV, Hepatitis B, C at screening; use of medications (except acetaminophen)or vitamins or herbal supplements within 7 days or 5 half lives prior to dosing and during study;
  • history of urinary retention, gastric retention, and other sever gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma or who are at risk for these conditions;
  • history of chronic constipation and/or regular laxative use; donation of more than 500mL of blood within 56 days prior to dosing;
  • clinically relevant abnormality identified during screening process or any medical condition or circumstance making the subject unsuitable for participation based on the Investigators assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Tacoma, Washington, 98418, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

solabegronoxybutynin

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • GSK Clinical Trials, MD

    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

July 13, 2007

First Posted

July 16, 2007

Study Start

June 1, 2007

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

US(1)