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Protocol Summary for 111406

Protocol Summary
Protocol Id: 111406
Secondary Ids:
  • N/A
Title: A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 after Single and Repeated Oral Dosing in Healthy Volunteers Using a Dose-Escalating, Randomized, Placebo-Controlled Study Design
Phase: phase 1
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: no
Study Type: Interventional
Oversight Authority:
  • United Kingdom: Medicines and Healthcare Products Regulatory Agency
Collaborators:
  • N/A
Brief Summary: A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers
Detailed Description:
Record Verification Date: May 2009
Status: Completed
Why Study Stopped:
Study Start Date: September 2008
Study Completion Date: August 2009
Study Completion Date Type: Actual
Primary Completion Date: August 2009
Primary Completion Date Type: Actual
Primary Purpose: treatment
Allocation: Randomized
Masking: Single Blind
Masked Subject: yes
Masked Caregiver: no
Masked Investigator: no
Masked Assessor: no
Study Design (Assignment): Crossover Assignment
Study Classification (Endpoint): Safety Study
Primary Outcomes:
  • • Safety and tolerability as determined by AE reporting and treatment effects on vital signs, ECG findings, haematology, clinical chemistry and urinalysis parameters, as well as 24-hour plasma cortisol profiles yes 72 hours and 14 days
Secondary Outcomes:
  • PK parameters per protocol no 72 hours and 14 days
Conditions:
  • Inflammatory Bowel Diseases
Keywords:
  • IBD
  • first time in humans
  • Phase 1
  • human volunteers
  • safety
  • pharmacokinetics
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Year
Maximum Age: 65 Year
Enrollment: 87
Enrollment Type: Actual
Healthy Volunteers?: yes
Central Contact: US GSK Clinical Trials Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact: EU GSK Clinical Trials Call Center
Backup Central Contact Phone: +44 (0) 20 8990 4466
Backup Central Contact Email: GSKClinicalSupportHD@gsk.com
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