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Protocol Summary for 112648

Protocol Summary
Protocol Id: 112648
Secondary Ids:
  • N/A
Title: An open-label, randomized, single sequence, two period study to assess the effect of repeat oral dosing of ketoconazole on the pharmacokinetics of a single oral dose of GSK962040 in healthy volunteers
Phase: phase 1
Acronym:
FDA Regulated Intervention?: Yes
Section 801 Clinical Trial?: No
Delayed Posting: No
IND/IDE Protocol?: yes
IND/IDE Grantor: CDER
IND/IDE Number: 105366
IND/IDE Serial Number:
Has Expanded Access?: no
Study Type: Interventional
Oversight Authority:
  • United States: Food and Drug Administration
Collaborators:
  • N/A
Brief Summary: This study will determine the effect of 400 mg ketoconazole on the pharmacokinetics of a single dose of GSK962040. The results from this study will help to estimate the maximum increase in exposure during concomitant use of strong CYP3A4 inhibitors. This study will also contain an exploratory investigation of biliary secretion of GSK962040 and or its metabolites.
Detailed Description:
Record Verification Date: April 2011
Status: Completed
Why Study Stopped:
Study Start Date: September 2009
Study Completion Date: December 2009
Study Completion Date Type: Actual
Primary Completion Date: November 2009
Primary Completion Date Type: Actual
Primary Purpose: treatment
Allocation: Randomized
Masking: Open Label
Masked Subject: no
Masked Caregiver: no
Masked Investigator: no
Masked Assessor: no
Study Design (Assignment): Single Group Assignment
Study Classification (Endpoint): Pharmacokinetics/dynamics Study
Primary Outcomes:
  • Pharmacokinetic parameters (AUC(0-inf), and Cmax) of GSK962040 Duration of dosing
Secondary Outcomes:
  • To characterize the nature of the GSK962040-related material in plasma, 24-hour urine, and bile. 24 h
  • Safety and tolerability assessments, consisting of AEs, ECGs, vital signs, clinical laboratory tests. yes Duration of dosing
  • Additional pharmacokinetic parameters of GSK962040, i.e., tmax, t1/2, AUC(0-t) Duration of dosing
Conditions:
  • Gastroparesis
Keywords:
  • ketoconazole
  • GSK962040
  • Drug-Drug Interaction
  • Phase I
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Year
Maximum Age: 65 Year
Enrollment: 20
Enrollment Type: Actual
Healthy Volunteers?: yes
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: Click to view location information