Back to resultsA Three-Part Study Of GSK580416 In Healthy Subjects
Primary Purpose
Respiratory Tract Infection, Infections, Bacterial
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
GSK580416
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Tract Infection focused on measuring tolerability,, pharmacokinetics,, first time in human,, food effect, safety,
Eligibility 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
Sites / Locations
- GSK Investigational Site
Outcomes
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.
Secondary Outcome Measures
Blood samples to determine drug levels in the body will be collected during the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00427141
Brief Title
A Three-Part Study Of GSK580416 In Healthy Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Infection, Infections, Bacterial
Keywords
tolerability,, pharmacokinetics,, first time in human,, food effect, safety,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GSK580416
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Blood samples to determine drug levels in the body will be collected during the study.
Time Frame
during the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Randwick, Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
12. IPD Sharing Statement
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A Three-Part Study Of GSK580416 In Healthy Subjects
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