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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00427141




Registration number
NCT00427141
Ethics application status
Date submitted
24/01/2007
Date registered
26/01/2007
Date last updated
4/06/2012

Titles & IDs
Public title
A Three-Part Study Of GSK580416 In Healthy Subjects
Scientific 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
Secondary ID [1] 0 0
OPS106400
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Tract Infection 0 0
Infections, Bacterial 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK580416

Treatment: Drugs: GSK580416
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
during the study
Secondary outcome [1] 0 0
Blood samples to determine drug levels in the body will be collected during the study.
Timepoint [1] 0 0
during the study

Eligibility
Key inclusion 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)
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Randwick, Sydney
Recruitment postcode(s) [1] 0 0
2031 - Randwick, Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00427141
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00427141