Back to resultsEvaluation of the Safety, Tolerability and Pharmacokinetics of Repeat Oral Doses of GSK580416
Primary Purpose
Bacterial Infection, Infections, Bacterial
Status
Terminated
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
GSK580416 oral tablets (250 mg) Ketoconazole oral tablets (200 mg)
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Infection focused on measuring GSK580416, ketoconazole interaction, pleuromutilin, oral dose
Eligibility 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.
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Safety and tolerability of GSK580416 doses determined from clinical safety and tolerability data from all adverse event reporting, 12-lead ECGs, vital signs, nursing/physician observation, and safety laboratory tests
Secondary Outcome Measures
Pharmacokinetics of GSK580416 as determined by AUC, Cmax, tmax, half-life, and Ct.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00680485
Brief Title
Evaluation of the Safety, Tolerability and Pharmacokinetics of Repeat Oral Doses of GSK580416
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Study Start Date
June 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infection, Infections, Bacterial
Keywords
GSK580416, ketoconazole interaction, pleuromutilin, oral dose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GSK580416 oral tablets (250 mg) Ketoconazole oral tablets (200 mg)
Primary Outcome Measure Information:
Title
Safety and tolerability of GSK580416 doses determined from clinical safety and tolerability data from all adverse event reporting, 12-lead ECGs, vital signs, nursing/physician observation, and safety laboratory tests
Secondary Outcome Measure Information:
Title
Pharmacokinetics of GSK580416 as determined by AUC, Cmax, tmax, half-life, and Ct.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Safety, Tolerability and Pharmacokinetics of Repeat Oral Doses of GSK580416
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