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OpenTrials
Completed

NCT Number: NCT00411866

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Dundee, DD1 9SY, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SB773812

Drug

SB-773812 20 mg will be available as white round film coated tablets.

Ketoconazole

Drug

Ketoconazole will be available as 200mg tablets.

Other names: SB773812

Primary outcomes

  1. Blood sampling over period of 336 hours post dosing with SB-773812

    Time frame: over period of 336 hours post dosing

Secondary outcomes

  1. Safety: ECG, vital signs, adverse events, clinical labs over 48 hours post SB-773812 dosing.

    Time frame: over 48 hours post SB-773812 dosing.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole 400mg on Pharmacokinetics of SB-773812 20mg

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Dec 15, 2006
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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