Effects Of The Drug Ketoconazole On How The Body Handles The Drug SB773812

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00411866
First received: December 13, 2006
Last updated: March 15, 2012
Last verified: February 2011
  Purpose

The purposes of this study are to determine if there is a difference in how SB-773812 is distributed through the bloodstream before and after multiple doses of ketoconazole have been given and to determine if there is a difference in how safe and well tolerated SB-773812 is when given on its own and given with ketoconazole.


Condition Intervention Phase
Schizophrenia
Healthy Subjects
Drug: SB773812
Drug: Ketoconazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole 400mg on Pharmacokinetics of SB-773812 20mg.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Blood sampling over period of 336 hours post dosing with SB-773812 [ Time Frame: over period of 336 hours post dosing ]

Secondary Outcome Measures:
  • Safety: ECG, vital signs, adverse events, clinical labs over 48 hours post SB-773812 dosing. [ Time Frame: over 48 hours post SB-773812 dosing. ]

Estimated Enrollment: 36
Study Start Date: October 2006
Intervention Details:
    Drug: SB773812 Drug: Ketoconazole
    Other Names:
    • Ketoconazole
    • SB773812
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Healthy
  • Body Weight >/=50kg and BMI 18.5-29.9 kg/m2 inclusive
  • Normal 12-lead ECG, physical examination and lab screen

Exclusion criteria:

  • A history of psychiatric illness,
  • A history or presence gastro-intestinal,
  • A hepatic or renal disease or orthostatic hypotension.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411866

Locations
United Kingdom
GSK Investigational Site
Dundee, Forfarshire, United Kingdom, DD1 9SY
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00411866     History of Changes
Other Study ID Numbers: NAA105416
Study First Received: December 13, 2006
Last Updated: March 15, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
safety
pharmacokinetics,

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
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 April 16, 2014