Last updated: 11/04/2018 05:47:07
To Evaluate Safety, Tolerability, Pharmacokinetics, And Food Effect Of Single Doses Of GSK945237 In Healthy Subjects
GSK study ID
BTI107248
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official 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
Trial description: 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
Primary purpose:
Other
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Safety and tolerability
Timeframe: Day 1 to follow-up visit
Secondary outcomes:
Pharmacokinetics
Timeframe: Day 1 to Day 5
Interventions:
Enrollment:
68
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Healthy Subjects, Infections, Bacterial
Product
GSK945237
Collaborators
Not applicable
Study date(s)
July 2007 to November 2008
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 60 years
Accepts healthy volunteers
Yes
- Healthy male and female adults between 18 and 60 years of age.
- Body weight proportional to height.
- 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.
Inclusion and exclusion criteria
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
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
Trial location(s)
Location
GSK Investigational Site
ADELAIDE, South Australia, Australia, 5000
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2008-04-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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