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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

January 24, 2007
May 31, 2012
October 2006
Not Provided
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 ]
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.
Complete list of historical versions of study NCT00427141 on ClinicalTrials.gov Archive Site
Blood samples to determine drug levels in the body will be collected during the study. [ Time Frame: during the study ]
Blood samples to determine drug levels in the body will be collected during the study.
Not Provided
Not Provided
 
A Three-Part Study Of GSK580416 In Healthy Subjects
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • Respiratory Tract Infection
  • Infections, Bacterial
Drug: GSK580416
Other Name: GSK580416
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
48
Not Provided
Not Provided

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00427141
OPS106400
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