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Protocol Summary for 114479

Protocol Summary
Protocol Id: 114479
Secondary Ids:
Title: A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase II Study to Evaluate the Safety and Efficacy and Dose Response of 28 Days of Once-Daily Dosing of the Oral Motilin Receptor Agonist GSK962040, in Type I and II Diabetic Male and Female Subjects with Gastroparesis
Phase: phase 2
Acronym:
FDA Regulated Intervention?: Yes
Section 801 Clinical Trial?: No
Delayed Posting: No
IND/IDE Protocol?: yes
IND/IDE Grantor: CDER
IND/IDE Number: 110287
IND/IDE Serial Number:
Has Expanded Access?: no
Study Type: Interventional
Oversight Authority:
  • United States: Food and Drug Administration
  • United States: Institutional Review Board
Collaborators:
Brief Summary: GSK962040 is a novel small molecule motilin agonist. The Phase I studies (MOT107043 and MOT109681) demonstrated that single doses of GSK962040 up to 150 mg and repeat dosing of up to 125 mg/day for 14 days were well tolerated with adverse events not occurring in greater prevalence than placebo, and no significant abnormal vital sign, ECG, or clinical laboratory findings. Pharmacokinetic parameters were linear and approximately dose proportional over the range of doses administered. Single doses of 50 mg – 150 mg GSK962040 significantly increased the rate of gastric emptying up to 40% as measured by the 13C octanoic acid stable isotope breath test. A similar effect of 50 mg and 125 mg on gastric emptying was observed throughout repeated dosing to healthy volunteers for 14-days. The aims of the present investigation (MOT114479) are to assess the pharmacodynamic effects (gastric emptying and symptoms), safety, tolerability, and pharmacokinetics of GSK962040 after 28 days of once-daily dosing in Type I and Type II diabetic subjects with gastroparesis. An additional aim is to characterize the dose/exposure – pharmacodynamic effect relationship.
Detailed Description:
Record Verification Date: April 2013
Status: Completed
Why Study Stopped:
Study Start Date: May 2011
Study Completion Date: February 2013
Study Completion Date Type: Actual
Primary Completion Date: February 2013
Primary Completion Date Type: Actual
Primary Purpose: treatment
Allocation: Randomized
Masking: Double Blind
Masked Subject: yes
Masked Caregiver: no
Masked Investigator: yes
Masked Assessor: yes
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Gastric half emptying time 28 days
  • Gastric emptying, as measured by the 13C-oal breath test 28 days
Secondary Outcomes:
  • Time to first bowel movement after first dose 28 days
  • Adverse Events (AEs) yes 28 days
  • change in GI symptoms 28 days
  • daily average stool consistency 28 days
  • cardiovascular parameters (12-lead ECG, heart rate, blood pressure) yes 28 days
  • daily bowel movement frequency 28 days
  • clinical chemistry and hematology parameters yes 28 days
  • Population pharmacokinetic parameters of GSK962040: Cmax, Tmax, AUC(0-t), Ct, CL/F, V/F, and, if possible, half-life 28 days
Conditions:
  • Gastroparesis
Keywords:
  • tolerability
  • pharmacokinetics
  • 13 C oral breath test
  • Type I and II Diabetes mellitus
  • gastroparesis
  • gut motility
  • phase II
  • pharmacodynamics
  • repeat dose
  • gastric emptying
  • symptoms
  • GSK962040
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Year
Maximum Age: 80 Year
Enrollment: 79
Enrollment Type: Actual
Healthy Volunteers?: none
Central Contact: Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: No locations currently recruiting for this study.