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Pharmacokinetic Study of Retigabine Extended Release (XR) Formulation in Healthy Adult Japanese and Caucasian Subjects

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: NCT01691872
Recruitment Status : Withdrawn (Development plan of retigabine XR in Japan was readjusted.)
First Posted : September 25, 2012
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE September 13, 2012
First Posted Date  ICMJE September 25, 2012
Last Update Posted Date September 17, 2018
Actual Study Start Date  ICMJE October 10, 2012
Actual Primary Completion Date October 18, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2012)
  • AUC0-∞ of retigabine [ Time Frame: up to 96h post dose ]
    Area under the concentration-time curve from pre-dose to last time of quantifiable concentration of retigabine
  • Cmax of retigabine [ Time Frame: up to 96h post dose ]
    Maximum observed concentration of retigabine
  • Tmax of retigabine [ Time Frame: up to 96h post dose ]
    Time of occurance of Cmax of retigabine
  • t1/2 of retigabine [ Time Frame: up to 96h post dose ]
    Terminal phase half-life of retigabine
  • Adverse Events [ Time Frame: up to 96h post dose ]
    Number of participants with adverse events as a measure of safety and tolerability (evaluated by the result of Clinical safety laboratory tests, vital signs, 12-lead ECG, telemetry and clinical monitoring/observation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2012)
  • AUC0-∞ of NAMR [ Time Frame: up to 96h post dose ]
    Area under the concentration-time curve from pre-dose to last time of quantifiable concentration of NAMR
  • Cmax of NAMR [ Time Frame: up to 96h post dose ]
    Maximum observed concentration of NAMR
  • Tmax of NAMR [ Time Frame: up to 96h post dose ]
    Time of occurance of Cmax of NAMR
  • t1/2 of NAMR [ Time Frame: up to 96h post dose ]
    Terminal phase half-life of NAMR
  • fe [ Time Frame: up to 96h post dose ]
    Percent of retigabine and NAMR excreted in urine
  • CLr [ Time Frame: up to 96h post dose ]
    Renal clearance of retigabine and NAMR
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 Pharmacokinetic Study of Retigabine Extended Release (XR) Formulation in Healthy Adult Japanese and Caucasian Subjects
Official Title  ICMJE An Open-label, Single Centre, Parallel Group Study to Evaluate the Safety and Pharmacokinetics of Single Oral Doses of Retigabine Extended Release (XR) Formulation in Healthy Adult Japanese and Caucasian Subjects
Brief Summary This is an open-label, single centre, parallel group study to evaluate the safety and pharmacokinetics of single oral doses of retigabine XR formulation in healthy adult Japanese subjects. To compare the pharmacokinetic and safety profile, Caucasian subjects are also incorporated. This study is intended to facilitate inclusion of Japanese patients in the global phase III program for retigabine XR formulation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Epilepsy, Partial
Intervention  ICMJE Drug: Retigabine
Retigabine
Study Arms  ICMJE
  • Experimental: Japanese
    Retigabine 300mg single-dose
    Intervention: Drug: Retigabine
  • Experimental: Caucasian
    Retigabine 300mg single-dose
    Intervention: Drug: Retigabine
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 7, 2013)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 20, 2012)
24
Actual Study Completion Date  ICMJE October 18, 2012
Actual Primary Completion Date October 18, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male subject between 20 and 45 years of age inclusive, at the time of signing the informed consent.
  • Japanese ancestry defined as being born in Japan, having four ethnic Japanese grandparents, holding a Japanese passport or identity papers and being able to speak Japanese. OR Caucasian defined as an individual having four grandparents who are all descendents of the original people of Europe.
  • Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and 12-lead ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
  • Body weight ≥ 50 kg and BMI within the range 18.5 - 24.9 kg/m2 (inclusive).
  • Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed separately. This criterion must be followed from the time of the first dose of study medication until 1 week post-last dose
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
  • Single QTcB or QTcF< 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.

Exclusion Criteria:

  • Subject has made a suicide attempt in the past or, in the investigator's judgment, poses a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behavior in the past 6 months and/or any suicidal ideation of type 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
  • A positive pre-study Hepatitis B surface antigen, Hepatitis C antibody or HIV antigen/antibody result within 3 months of screening
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • A positive pre-study drug/alcohol screen.
  • History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 g of alcohol: 360 ml of beer, 150 ml of table wine or 45 ml of 80 proof distilled spirits.
  • 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 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.
  • Unable to refrain from the 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, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
  • 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 56 day period.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  • Subject is mentally or legally incapacitated.
  • 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.
  • Unable to refrain from consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01691872
Other Study ID Numbers  ICMJE 116247
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date September 2018

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