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A Healthy Volunteer Study to Assess the Relative Bioavailability of 2 Forms of SB773812 Tablets.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00500201
First received: July 10, 2007
Last updated: May 31, 2012
Last verified: February 2011
  Purpose

Study to compare PK of a new 120mg tablet with two 60mg tablets. This is required because we plan to have only single tablets administered in the later phase clinical trials but we have not had a 120mg strength before. As this is a new previously untested strength we need to ensure that the PK is similar to that achieved using 2x60mg before we start a large manufacturing campaign and before we administer to a large number of patients. The study is planned to consist of a single part, with two dosing periods, periods 1 and 2 consisting of 18 subjects. There will be 20 days washout between each dose. Initially 4 subjects will be given a single oral dose of 120 mg SB-773812 and 2 will be given placebo. If 120mg SB-773812 is well tolerated in the first four volunteers, the remaining 12 subjects will be dosed. If the 120mg single oral dose in the first 4 subjects is poorly tolerated, the study will be stopped. Subjects will return to the centre for follow-up 14 to 21 days after the final dose.It is expected that the total duration of the study should be approximately 11 weeks.


Condition Intervention Phase
Schizophrenia
Drug: SB- 773812
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Single Blind, Double Dummy, Placebo Controlled, Randomized, 2 Period Crossover Study to Assess the Relative Bioavailability of a 120mg Tablet Compared to Two 60 mg SB-773812 Tablets in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Blood sampling over a period 336 hrs post SB773812 dosing in both dosing sessions. [ Time Frame: 336 hrs post SB773812 dosing ]

Secondary Outcome Measures:
  • Safety: ECG, vital signs, clinical labs over 336 hours post SB-773812 dosing in both dosing sessions. [ Time Frame: 336 hours post SB-773812 dosing ]
  • Continuous adverse event monitoring from dosing until study conclusion and follow up, 7-14days after last dose. [ Time Frame: 7-14days after last dose ]

Enrollment: 18
Study Start Date: May 2007
Intervention Details:
    Drug: SB- 773812
    Other Name: SB- 773812
  Eligibility

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

Inclusion Criteria:

  • be a healthy man or woman, aged 18 to 55, and be neither too fat nor too thin;
  • If you are a woman who can have a baby, you must use an acceptable method of contraception, from the start of your last period before you take the study medicine, until you've had your first normal period after the end of the study. You might need to use contraception for longer than that. You don't need to use contraception if your partner has been sterilized (had an operation to cut the tubes that carry sperm).
  • Acceptable methods of contraception for women are:
  • Diaphragm or cap and condom with spermicide;
  • the 'Pill' and condom with spermicide — you must have been taking the 'Pill' for at least 3 months before the start of the study;
  • Intrauterine device (IUD or 'coil' — your GP must confirm that you have one) and condom with spermicide; or
  • Condom and spermicide only, if you're a woman who has had an operation to have your tubes tied.
  • If you are a woman who CANNOT have a baby, you should have gone through menopause at least 1 year ago;
  • had your womb removed; or
  • had both ovaries removed.
  • have normal physical exam
  • have normal blood pressure and pulse.
  • be able to swallow tablets;
  • show proof of identity — we'll tell you what's suitable.
  • have the ability to understand and comply with protocol requirements, instructions and restrictions.
  • be available to attend the ward for repeat tests, if necessary, during the 2 weeks after your final planned visit.

Exclusion Criteria:

  • abuse alcohol or drugs;
  • drink, on average, more than 3 units of alcohol daily if you're a man, or 2 units if you're a woman (1 unit = ½ pint of beer, 1 small glass of wine or 1 measure of spirits);
  • have been a blood donor in the last 3 months;
  • have been given an experimental medicine in the last 3 months;
  • have taken part in a study of an experimental medicine in the last 3 months;
  • be a smoker, or have smoked cigarettes or used other tobacco products regularly in the last 6 months — we may test your breath for smoking at any time during the study;
  • be pregnant or breast feeding;
  • have had a serious reaction to any medicine;
  • have any screening test results that show you're not suitable, even if they don't mean that you're unhealthy;
  • have had any important illness (including diabetes and asthma) that, in the opinion of the study doctor, makes you unsuitable for the study;
  • have had any mental illnesses;
  • suffer from numbness or tingling in your arms, legs, hands or feet; or
  • has had glaucoma (increased pressure inside the eye).
  • You may not be able to take part if you've taken any medicines recently, including herbal remedies like St John's wort.
  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: NCT00500201

Locations
United Kingdom
GSK Investigational Site
London, United Kingdom, NW10 7NS
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00500201     History of Changes
Other Study ID Numbers: NAA105737
Study First Received: July 10, 2007
Last Updated: May 31, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by GlaxoSmithKline:
Healthy Volunteer

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 25, 2014