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Evaluation of the Safety, Tolerability and Pharmacokinetics of Repeat Oral Doses of GSK580416

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00680485
First received: April 14, 2008
Last updated: May 31, 2012
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Bacterial Infection
Infections, Bacterial
 Drug: GSK580416 oral tablets (250 mg) Ketoconazole oral tablets (200 mg)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

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.

Estimated Enrollment: 96
Study Start Date: June 2007
Intervention Details:
    Drug: GSK580416 oral tablets (250 mg) Ketoconazole oral tablets (200 mg)
    Other Name: GSK580416 oral tablets (250 mg) Ketoconazole oral tablets (200 mg)
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00680485

Locations
Australia, South Australia
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00680485     History of Changes
Other Study ID Numbers: OPS108221
Study First Received: April 14, 2008
Last Updated: May 31, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:
GSK580416
ketoconazole interaction
pleuromutilin
oral dose

Additional relevant MeSH terms:
Bacterial Infections
Ketoconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013