Safety, Tolerability and Pharmacokinetics of Repeat Doses of GSK1014802.
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
2 other identifiers
interventional
51
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2008
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 31, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2008
CompletedFirst Submitted
Initial submission to the registry
May 7, 2009
CompletedFirst Posted
Study publicly available on registry
May 25, 2009
CompletedOctober 30, 2017
October 1, 2017
7 months
May 7, 2009
October 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Safety and tolerability will be evaluated by monitoring AEs and concomitant medication, ECG, Lead II monitoring, Holter monitoring, vital signs, and laboratory parameters.
14-28 days
Blood concentrations of GSK1014802 following a single oral dose of GSK1014802.
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.
14-28 days
Blood concentrations of GSK1014802 following repeated oral doses of GSK1014802 given once daily with or without food.
14-28 days
Secondary Outcomes (1)
Bond-Lader VAS scale
14-28 days
Study Arms (4)
Cohort 1
OTHERCohort 4
OTHERCohort 3
OTHERCohort 2
OTHERInterventions
Sodium channel blocker
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (1)
GSK Investigational Site
London, SE1 1YR, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Biogen Medical Director
Biogen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2009
First Posted
May 25, 2009
Study Start
May 31, 2008
Primary Completion
December 31, 2008
Study Completion
December 31, 2008
Last Updated
October 30, 2017
Record last verified: 2017-10