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Safety, Tolerability and Pharmacokinetics of Repeat Doses of GSK1014802.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00908154
Recruitment Status : Completed
First Posted : May 25, 2009
Last Update Posted : October 30, 2017
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date  ICMJE May 7, 2009
First Posted Date  ICMJE May 25, 2009
Last Update Posted Date October 30, 2017
Actual Study Start Date  ICMJE May 31, 2008
Actual Primary Completion Date December 31, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2009)
  • Safety and tolerability will be evaluated by monitoring AEs and concomitant medication, ECG, Lead II monitoring, Holter monitoring, vital signs, and laboratory parameters. [ Time Frame: 14-28 days ]
  • Blood concentrations of GSK1014802 following a single oral dose of GSK1014802. [ Time Frame: 1 day ]
  • Blood concentrations of GSK1014802 following repeated oral doses of GSK1014802 given once daily or twice daily and their relationship with the GSK1014802 exposure after a single dose. [ Time Frame: 14-28 days ]
  • Blood concentrations of GSK1014802 following repeated oral doses of GSK1014802 given once daily with or without food. [ Time Frame: 14-28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2009)
Bond-Lader VAS scale [ Time Frame: 14-28 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Pharmacokinetics of Repeat Doses of GSK1014802.
Official Title  ICMJE Single-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeat Doses of GSK1014802 and Its Interaction With Food in Healthy Volunteers
Brief Summary

GSK1014802 is a use-dependent sodium channel blocker and an effective anticonvulsant in animal models.

This study is being conducted to obtain information regarding the safety, tolerability and pharmacokinetics of repeated doses of GSK1014802 administered for up to 28 days in healthy male or female subjects. In addition, the effect of food on the pharmacokinetics of GSK1014802 will be investigated.

Detailed Description This study, previously posted by GlaxoSmithKline (GSK), was transitioned to Convergence Pharmaceuticals, Ltd., which spun off from GSK. Convergence Pharmaceuticals, Ltd., has now been acquired by Biogen.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar Depression
  • Bipolar Disorder
Intervention  ICMJE
  • Drug: Placebo
    Tablets to match GSK1014802
  • Drug: GSK1014802
    Sodium channel blocker
    Other Name: BIIB074 and CNV1014802
Study Arms  ICMJE
  • Cohort 1
    Interventions:
    • Drug: Placebo
    • Drug: GSK1014802
  • Cohort 4
    Interventions:
    • Drug: Placebo
    • Drug: GSK1014802
  • Cohort 3
    Interventions:
    • Drug: Placebo
    • Drug: GSK1014802
  • Cohort 2
    Interventions:
    • Drug: Placebo
    • Drug: GSK1014802
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2009)
51
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2008
Actual Primary Completion Date December 31, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.

    • Male or female (of non-child bearing potential) subjects aged between 18 and 55 years.
    • A female subject is eligible to participate if she is of non-childbearing potential.
    • Male subjects must agree to use an acceptable form of contraception.
    • Body weight ≥ 50 kg and BMI within the range 19 - 29.9 kg/m2 (inclusive)
    • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
    • QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.

Exclusion Criteria:

  • The subject has a positive pre-study drug/alcohol screen.

    • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
    • A positive test for HIV antibody.
    • History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females).
    • Current or past history of symptomatic orthostatic hypotension or history of unexplained vasovagal episode(s).
    • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives (60 h) or twice the duration of the biological effect of the investigational product (whichever is longer).
    • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
    • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication.
    • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
    • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
    • Pregnant females.
    • Lactating females.
    • Unwillingness or inability to follow the procedures outlined in the protocol.
    • History of sensitivity to heparin or heparin-induced thrombocytopenia.
    • Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
    • . Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
    • History of known or suspected seizures, including infantile febrile, unexplained significant and recent loss of consciousness or history of significant head trauma with loss of consciousness or a family history (first degree relative) of epilepsy or seizures (fits).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00908154
Other Study ID Numbers  ICMJE 107727
SCB107727
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Biogen Medical Director Biogen
PRS Account Biogen
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP