Safety, Tolerability and Pharmacokinetics of Repeat Doses of GSK1014802.

Last updated: October 27, 2017
Sponsor: Biogen
Overall Status: Completed

Phase

1

Condition

Depression

Depression (Treatment-resistant)

Bipolar Disorder

Treatment

N/A

Clinical Study ID

NCT00908154
107727
SCB107727
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy as determined by a responsible physician, based on a medical evaluationincluding medical history, physical examination, laboratory tests and cardiacmonitoring.

  • Male or female (of non-child bearing potential) subjects aged between 18 and 55years.

  • A female subject is eligible to participate if she is of non-childbearingpotential.

  • 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 therequirements and restrictions listed in the consent form.

  • QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.

Exclusion

Exclusion Criteria:

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

  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibodyresult within 3 months of screening

  • A positive test for HIV antibody.

  • History of regular alcohol consumption within 6 months of the study defined as anaverage weekly intake of greater than 21 units or an average daily intake ofgreater than 3 units (males), or defined as an average weekly intake of greaterthan 14 units or an average daily intake of greater than 2 units (females).

  • Current or past history of symptomatic orthostatic hypotension or history ofunexplained vasovagal episode(s).

  • The subject has participated in a clinical trial and has received aninvestigational product within the following time period prior to the firstdosing day in the current study: 30 days, 5 half-lives (60 h) or twice theduration of the biological effect of the investigational product (whichever islonger).

  • Exposure to more than four new chemical entities within 12 months prior to thefirst dosing day.

  • Use of prescription or non-prescription drugs, including vitamins, herbal anddietary supplements (including St John's Wort) within 7 days (or 14 days if thedrug is a potential enzyme inducer) or 5 half-lives (whichever is longer) priorto the first dose of study medication.

  • History of sensitivity to any of the study medications, or components thereof ora history of drug or other allergy that, in the opinion of the investigator orGSK Medical Monitor, contraindicates their participation.

  • Where participation in the study would result in donation of blood or bloodproducts 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 oftobacco- or nicotine-containing products within 6 months prior to screening.

  • . Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/orpummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 daysprior to the first dose of study medication.

  • History of known or suspected seizures, including infantile febrile, unexplainedsignificant and recent loss of consciousness or history of significant headtrauma with loss of consciousness or a family history (first degree relative) ofepilepsy or seizures (fits).

Study Design

Total Participants: 51
Study Start date:
May 31, 2008
Estimated Completion Date:
December 31, 2008

Study 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.

Connect with a study center

  • GSK Investigational Site

    London, SE1 1YR
    United Kingdom

    Site Not Available

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