A Three-Part Study Of GSK580416 In Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00427141
First received: January 24, 2007
Last updated: May 31, 2012
Last verified: February 2011
  Purpose

Studies for GSK580416 have been completed in rats and dogs. The main toxic effects seen in animals affected the digestive system and blood cells. Study OPS106400 will be the first administration of GSK580416 in humans. Parts A and B of this study will examine the safety, tolerability, and pharmacokinetics of increasing single doses of GSK580416 with reference to placebo. Part C of the study will assess the effect of food on the safety, tolerability, and pharmacokinetics of a single dose of GSK580416 in healthy subjects.


Condition Intervention Phase
Respiratory Tract Infection
Infections, Bacterial
Drug: GSK580416
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Three-part First Time in Human Study to Evaluate Safety, Tolerability, Pharmacokinetics and Food Effect of Single Oral Doses of GSK580416 in Healthy Adult Subjects

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Safety assessments (adverse event, ECG and vital sign) will be performed during the study. Blood samples to determine drug levels in the body will be collected during the study. [ Time Frame: during the study ]

Secondary Outcome Measures:
  • Blood samples to determine drug levels in the body will be collected during the study. [ Time Frame: during the study ]

Enrollment: 48
Study Start Date: October 2006
Intervention Details:
    Drug: GSK580416
    Other Name: GSK580416
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Healthy as determined by a physician
  • Healthy male or female of non-child bearing potential between 18 and 55 years of age (inclusive)
  • Body weight > = 50 kg and BMI between 19 and 30 kg/m2 (inclusive)

Exclusion criteria:

  • Positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody with 3 months of screening
  • Male and female subjects not willing to follow study specified contraceptive methods
  • Subjects taking any recreational drugs
  • Regular use of tobacco- or nicotine-containing products within 6 months prior to screening
  • Has participated in a clinical trial and have not received a drug within 30 days before the dose of study drug
  • Has exposed to more than 4 new chemical entities within 12 months before the first dosing day
  • Use of prescription or over-the-counter medications within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study drug
  • Use of St. John's Wort within 28 days before the first dose of study drug
  • Subjects not willing to follow study specified life style restrictions
  • Blood donation in excess of 500 mL within a 56 days period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427141

Locations
Australia, New South Wales
GSK Investigational Site
Randwick, Sydney, New South Wales, Australia, 2031
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00427141     History of Changes
Other Study ID Numbers: OPS106400
Study First Received: January 24, 2007
Last Updated: May 31, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:
tolerability,
pharmacokinetics,
first time in human,
food effect
safety,

Additional relevant MeSH terms:
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014