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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/NCT00517673




Registration number
NCT00517673
Ethics application status
Date submitted
15/08/2007
Date registered
17/08/2007
Date last updated
19/03/2012

Titles & IDs
Public title
To Evaluate Safety, Tolerability, Pharmacokinetics, And Food Effect Of Single Doses Of GSK945237 In Healthy Subjects
Scientific title
A Two-Part Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Escalating Oral Doses of GSK945237 and the Effect of Food on Single Oral Doses of GSK945237 in Healthy Adult Subjects
Secondary ID [1] 0 0
BTI107248
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Subjects 0 0
Infections, Bacterial 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK945237
Treatment: Drugs - Sugar Pill

Experimental: GSK945237 - Active Study Drug

Placebo Comparator: Sugar Pill - Placebo


Treatment: Drugs: GSK945237


Treatment: Drugs: Sugar Pill
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability
Timepoint [1] 0 0
Day 1 to follow-up visit
Secondary outcome [1] 0 0
Pharmacokinetics
Timepoint [1] 0 0
Day 1 to Day 5

Eligibility
Key inclusion criteria
- Healthy male and female adults between 18 and 60 years of age.

- Body weight proportional to height.

- Female subjects must be of non-childbearing potential.

- QTc less than 450 msec at screening
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Any clinically relevant abnormality identified on the screening history and physical,
or on laboratory evaluations or the 12-lead surface electrocardiogram at screening or
pre-dose.

- A positive pre-study alcohol/urine drug screen.

- Use of nicotine-containing products.

- A positive pre-study HIV antibody, Hepatitis B surface antigen (HBsAg) or Hepatitis C
antibody result.

- Recent participation in another study, use of certain medications, consumption certain
fruits, juices, or red wine

Study design
Purpose of the study
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?
The people receiving the treatment/s


Intervention assignment
Parallel
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
1/07/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2008
Sample size
Target
Accrual to date
Final
68
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
GSK Investigational Site - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

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

Ethics approval
Ethics application status

Summary
Brief summary
GSK945237 is the first molecule of a new chemical class that is being developed for treatment
of respiratory tract and other infections such as skin and soft tissue. This study drug has
been tested in animals but has never been given to humans. This is a two part study. The
purpose of the first part is to study the side effects of this drug in humans, and to study
how much of the drug gets absorbed in the blood stream The second part of this study will
compare absorption of the study drug in the blood stream when given with food and when given
under fasting conditions
Trial website
https://clinicaltrials.gov/ct2/show/NCT00517673
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/NCT00517673