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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014