Last updated: 11/04/2018 10:07:01
Evaluation of the safety, tolerability and pharmacokinetics of repeat oral doses of GSK580416
GSK study ID
OPS108221
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Trial overview
Official title: A three part study in healthy adult subjects to evaluate the safety, tolerability and pharmacokinetics of repeat escalating oral doses of GSK580416; the safety, tolerability, and pharmacokinetics of GSK580416 following a loading dose regimen; and the effect of ketoconazole on the pharmacokinetics of GSK580416
Trial description: This study will evaluate the safety, tolerability and exposure of repeat escalating oral doses, a loading dose/maintenance dose regimen of GSK580416 and when co administered with ketoconazole, a PGP/CYP3A4 inhibitor.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: GSK580416 oral tablets (250 mg) Ketoconazole oral tablets (200 mg)
Enrollment:
96
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Bacterial Infection, Infections, Bacterial
Product
GSK580416
Collaborators
Not applicable
Study date(s)
June 2007 to October 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 64 years
Accepts healthy volunteers
Yes
- Healthy adults (as determined by medical evaluation including history, physical exam, vital signs, laboratory tests, and cardiac monitoring)
- Aged 18-60yrs, with BMI of 19-31kg/m2.
- Clinically significant CNS, cardiac, pulmonary, metabolic, renal, hepatic or GI condition or history that may place the subject at an unacceptable risk or may interfere with absorption, distribution, metabolism, or excretion of drug.
- Positive urine drug screen.
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy adults (as determined by medical evaluation including history, physical exam, vital signs, laboratory tests, and cardiac monitoring)
- Aged 18-60yrs, with BMI of 19-31kg/m2.
- Females must be of non-childbearing potential.
- QTc < 450 msec at screening.
- Subjects must be able to give consent and comply with restrictions of study.
Exclusion criteria:
- Clinically significant CNS, cardiac, pulmonary, metabolic, renal, hepatic or GI condition or history that may place the subject at an unacceptable risk or may interfere with absorption, distribution, metabolism, or excretion of drug.
- Positive urine drug screen.
- Positive urine test for alcohol.
- Positive HIV or Hep B and/or C assay.
- History of regular tobacco use within 3 monts prior to screening or cotinine levels indicative of smoking at screening.
- History of regular alcohol consumption (14 units/week for women and 21 units/week for men).
- History of drug abuse or dependence within 12 months of study.
- Participation in another drug trial within 30 days of first dose.
- Exposure to more than 4 new chemical entities within 12 months of first dose.
- Use of prescription and non-prescription drugs including vitamins, dietary supplements, herbals within 7 days of first dose or St. John’s Wort within 28 days of the first dose.
- Consumption of red wine, Seville oranges, grapefruit, or grapefruit juices within 14 days of first dose.
- Donation of blood in excess of 500 mL within 56 days of dosing. No blood donation is allowed 30 days prior to study participation.
- A positive immunochemical fecal occult blood test at screening.
- History of sensitivity to any of the study medications.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- History of orthostatic hypotension or orthostatic hypotension at screening.
Trial location(s)
Location
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Status
Terminated/Withdrawn
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Terminated (halted prematurely)
Actual primary completion date
Not applicable
Actual study completion date
2007-26-10
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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