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

Bacterial Infection Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00680485
• Other study ID #: OPS108221
• Status: Terminated
• Phase: Phase 1
• First received: April 14, 2008
• Last updated: January 19, 2017
• Start date: June 2007
• Est. completion date: October 2007

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 96
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infection
• Bacterial Infections
• Communicable Diseases
• Infection
• Infections, Bacterial

Intervention

Drug:
• GSK580416 oral tablets (250 mg) Ketoconazole oral tablets (200 mg)

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics of GSK580416 as determined by AUC, Cmax, tmax, half-life, and Ct.