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A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00721812
First received: July 22, 2008
Last updated: May 11, 2017
Last verified: May 2017
  Purpose
A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers

Condition Intervention Phase
Inflammatory Bowel Diseases Drug: GSK1399686 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant
Primary Purpose: Treatment
Official 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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • • 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 [ Time Frame: 72 hours and 14 days ]

Secondary Outcome Measures:
  • PK parameters per protocol [ Time Frame: 72 hours and 14 days ]

Enrollment: 87
Actual Study Start Date: September 25, 2008
Study Completion Date: May 27, 2009
Primary Completion Date: May 27, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Part A
Single dose escalation
Drug: GSK1399686
Safety and tolerability dose escalation in normal human volunteers
Part B
14 day repeat dose escalation
Drug: GSK1399686
Safety and tolerability dose escalation in normal human volunteers
Part C
Fixed dose food effect
Drug: GSK1399686
Safety and tolerability dose escalation in normal human volunteers

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Healthy as determined by a responsible physician
  • Male, or only for the RDF cohort female of non-childbearing potential, between 18 and 65 years of age.
  • Body weight greater than 50 kg (110 lbs) and BMI within the range 18.5-29.9 kg/m2 (inclusive).
  • QTcB or QTcF < 450 msec
  • Capable of giving written informed consent

Exclusion criteria:

  • The subject has a positive pre-study drug/alcohol screen
  • History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 21 units
  • Urinary cotinine levels indicative of active smoking or regular use of tobacco
  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
  • A positive test for HIV antibody
  • The subject has participated in a clinical trial and has received an investigational product within 30 days, 5 half-lives of the investigational product
  • Exposure to more than four new chemical entities within 12 months
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days
  • Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices within 7 days
  • Subject is receiving hormone replacement therapy
  • History of sensitivity to any of the study medications
  • History of sensitivity to heparin or heparin-induced thrombocytopenia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721812

Locations
United Kingdom
GSK Investigational Site
Harrow, Middlesex, United Kingdom, HA1 3UJ
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 111406
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 111406
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 111406
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 111406
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 111406
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 111406
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 111406
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00721812     History of Changes
Other Study ID Numbers: 111406
Study First Received: July 22, 2008
Last Updated: May 11, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
pharmacokinetics
Phase 1
first time in humans
IBD
safety
human volunteers

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on June 23, 2017