A Three-Part Study Of GSK580416 In Healthy Subjects

Infections, Bacterial Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00427141
• Other study ID #: OPS106400
• Status: Completed
• Phase: Phase 1
• First received: January 24, 2007
• Last updated: May 31, 2012
• Start date: October 2006

Study information

• Verified date: February 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Infections
• Infection
• Infections, Bacterial
• Respiratory Tract Infection
• Respiratory Tract Infections

Intervention

Drug:
• GSK580416

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Randwick, Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		during the study
Secondary	Blood samples to determine drug levels in the body will be collected during the study.		during the study