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A Study to Evaluate and Study Drug Levels in Blood Plasma When Giving High Doses of GSK189075 to Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00501930
First received: July 13, 2007
Last updated: May 31, 2012
Last verified: February 2011
History of Changes

July 13, 2007
May 31, 2012
April 2007
Not Provided
Clinical laboratory tests, ECGs, adverse events [ Time Frame: screening, Day -1 - 3 all periods, follow up ]
Clinical laboratory tests, ECGs, adverse events : screening, Day -1 - 3 all periods, follow up [ Time Frame: screening, Day -1 - 3 all periods, follow up ]
Complete list of historical versions of study NCT00501930 on ClinicalTrials.gov Archive Site
  • blood plasma levels of GSK189075 [ Time Frame: Day 3 ]
  • clinical lab tests [ Time Frame: each day ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate and Study Drug Levels in Blood Plasma When Giving High Doses of GSK189075 to Healthy Volunteers
A Randomized, Placebo-Controlled, Double-Blind, Repeat Dose, Dose Escalation Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Supratherapeutic Doses of GSK189075 Administered for 3 Days in Healthy Volunteers

This study will assess safety and tolerability when taking GSK189075 at doses that are likely to be higher than the expected prescribed doses. The study will also measure the level of GSK189075 in blood after dosing as well as the effect of the drug on certain laboratory tests performed on volunteer urine and blood. Each volunteer will take part in 3 dosing periods and will be given a different dose level at each period (either 2000mg, 4000mg, or a placebo). Volunteers will not know which of the three doses they are receiving. In each period, volunteers will dose every morning for three straight days. Before and after dosing, blood pressure, heart rate, laboratory tests on blood and urine, physical examinations and ECGs will be taken to assess safety. Volunteers will also be asked to provide information should they feel they are having a possible effect from the GSK189075. The levels of GSK189075 in the blood will be assessed by multiple blood draws, most of these will follow the third dose in each period. Depending on the results from the preceding periods, a fourth period may be added to the study to assess another dose level. The fourth period, if this is to occur, will be the same design as the other three periods, and the dose received will be less than 4000mg.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Diabetes Mellitus, Type 2
Drug: GSK189075
Other Name: GSK189075
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
Not Provided
Not Provided

Inclusion Criteria:

  • Healthy males and non-pregnant females as determined by a physician on the basis of medical history (including family history of heart disease), physical examination, and clinical laboratory tests.
  • written consent given
  • agreement to follow specific requirements of birth control during participation.

Exclusion Criteria:

  • history of drug or alcohol abuse within one year of the study screening.
  • use of tobacco or nicotine-containing products with 6 months prior to the study screening.
  • use of any prescription or non-prescription drugs, vitamins, herbal, and dietary supplements within 14 days of the start of the study.
  • blood donation within 56 days before the start of the study
  • receiving other investigational drugs or participating in other research trials within 30 days of the start of this study.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00501930
KG2109799
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP