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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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Drug: GSK189075
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Clinical laboratory tests, ECGs, adverse events [ Time Frame: screening, Day -1 - 3 all periods, follow up ]

Secondary Outcome Measures:
  • blood plasma levels of GSK189075 [ Time Frame: Day 3 ]
  • clinical lab tests [ Time Frame: each day ]

Enrollment: 12
Study Start Date: April 2007
Intervention Details:
    Drug: GSK189075
    Other Name: GSK189075
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT00501930

Locations
United States, Wisconsin
GSK Investigational Site
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00501930     History of Changes
Other Study ID Numbers: KG2109799
Study First Received: July 13, 2007
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Dose Escalation;
Supratherapeutic;
GSK189075;
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014