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Completed

NCT Number: NCT00427141

A Three-Part Study Of GSK580416 In Healthy 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.

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Key information

Conditions

Respiratory Tract Infection Bacterial Infections Bacterial Infections and Mycoses Infections Infections, Bacterial Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Randwick, Sydney, New South Wales, 2031, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GSK580416

Drug

Primary outcomes

  1. 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 outcomes

  1. Blood samples to determine drug levels in the body will be collected during the study.

    Time frame: during the study

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2006
First posted
Jan 26, 2007
Registry last updated
Jun 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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