Last updated: 11/04/2018 10:06:39

To Study And Compare Bioavailability And Safety Of Four Different Formulations Of The Study Drug

GSK study ID
OPB107935
Clinicaltrials.gov ID
NCT00436228
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An open-label, randomized, crossover study to estimate the formulation effect on the relative bioavailability of single dose oral SB-742510 in healthy subjects
Trial description: SB-742510 is a semi-synthetic pleuromutilin antibiotic that is being developed for treatment of respiratory infections.
The purpose of this study is to estimate the bioavailability of four different formulations and to evaluate the safety of each of the four formulations
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
32
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
SB742510
Collaborators
Not applicable
Study date(s)
November 2006 to February 2007
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 60 years
Accepts healthy volunteers
Yes
  • Healthy as determined by a responsible physician, based on medical evaluations performed at screening.
  • Healthy adults between 18 and 60 years of age, inclusive.
  • Any clinically relevant abnormality identified on the screening history and physical or on the 12-lead surface electrocardiogram at screening or pre-dose.
  • The subject has a positive pre-study alcohol/urine drug screen.
Inclusion and exclusion criteria
Inclusion criteria:
  • Healthy as determined by a responsible physician, based on medical evaluations performed at screening.
  • Healthy adults between 18 and 60 years of age, inclusive.
  • Body weight proportional to height.
  • Capable of giving written informed consent.
  • 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 the 12-lead surface electrocardiogram at screening or pre-dose.
  • The subject has a positive pre-study alcohol/urine drug screen.
  • History of regular use of tobacco, or nicotine-containing products.
  • A positive pre-study HIV antibody, Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody result within 3 months of screening.
  • Use of certain prescription or non-prescription drugs, including vitamins, herbal and dietary supplements.
  • An unwillingness to comply with lifestyle and/or dietary restrictions.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Tacoma, Washington, United States, 98418
Status
Study Complete
Contact us

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
2007-11-02

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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website