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A Study to Evaluate the Effect of Single Doses of Drug A (Lamotrigine) and Drug B (Vofopitant) Alone and in Combination on Resting Motor Threshold in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00907985
Recruitment Status : Terminated (Slow recruitment; trial unlikely to reach completion)
First Posted : May 25, 2009
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE May 7, 2009
First Posted Date  ICMJE May 25, 2009
Last Update Posted Date July 21, 2017
Actual Study Start Date  ICMJE May 15, 2009
Actual Primary Completion Date June 10, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2009)
Effect of the study treatments on Resting Motor Thresholds (rMT) [ Time Frame: Within 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00907985 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2009)
The safety and tolerability of the combination of study treatments. [ Time Frame: Within 24 hours ]
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 A Study to Evaluate the Effect of Single Doses of Drug A (Lamotrigine) and Drug B (Vofopitant) Alone and in Combination on Resting Motor Threshold in Healthy Subjects
Official Title  ICMJE Double Blind, Double-dummy, Randomised, Placebo Controlled Study to Evaluate the Effect of Single Doses of Drug A (Lamotrigine) and Drug B (Vofopitant) Alone and in Combination on Resting Motor Threshold in Healthy Subjects
Brief Summary

The purpose of this study is to investigate the effect of drug A on its own and when it is given in combination with drug B on markers of brain activity. The study will

  1. Assess the effects of drug A and drug B on muscle movement after brain stimulation;
  2. Examine how the body handles (absorbs, distributes, breaks down and gets rid of) drug A and drug B when given in combination;
  3. Examine the safety of drug A and drug B when given together.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Bipolar Disorder
Intervention  ICMJE
  • Drug: Placebo
    Single dose of placebo will be provided.
  • Drug: Vofopitant
    Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.
  • Drug: Lamotrigine
    Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
Study Arms  ICMJE
  • Experimental: Treatment sequence A
    Subjects on sequence A will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session A of part 2 and placebo + vofopitant 10 milligrams capsule in session B of part 2.
    Interventions:
    • Drug: Placebo
    • Drug: Vofopitant
    • Drug: Lamotrigine
  • Experimental: Treatment sequence B
    Subjects on sequence B will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of placebo + vofopitant 10 milligrams capsule in session A of part 2 and lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session B of part 2.
    Interventions:
    • Drug: Placebo
    • Drug: Vofopitant
    • Drug: Lamotrigine
  • Experimental: Treatment sequence C
    Subjects on sequence C will receive single dose of placebo in part 1, single doses of lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session A of part 2 and placebo + vofopitant 10 milligrams capsule in session B of part 2.
    Interventions:
    • Drug: Placebo
    • Drug: Vofopitant
    • Drug: Lamotrigine
  • Experimental: Treatment sequence D
    Subjects on sequence D will receive single dose of placebo in part 1, single doses of placebo + vofopitant 10 milligrams capsule in session A of part 2 and lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session B of part 2.
    Interventions:
    • Drug: Placebo
    • Drug: Vofopitant
    • Drug: Lamotrigine
  • Experimental: Treatment sequence E
    Subjects on sequence E will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session A of part 2 and placebo + placebo in session B of part 2.
    Interventions:
    • Drug: Placebo
    • Drug: Vofopitant
    • Drug: Lamotrigine
  • Experimental: Treatment sequence F
    Subjects on sequence F will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session B of part 2.
    Interventions:
    • Drug: Placebo
    • Drug: Vofopitant
    • Drug: Lamotrigine
  • Experimental: Treatment sequence G
    Subjects on sequence G will receive single dose of placebo in part 1, single doses of lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session A of part 2 and placebo + placebo in session B of part 2.
    Interventions:
    • Drug: Placebo
    • Drug: Vofopitant
    • Drug: Lamotrigine
  • Experimental: Treatment sequence H
    Subjects on sequence H will receive single dose of placebo part 1, single doses of placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + vofopitant 10 milligrams capsule in session B of part 2.
    Interventions:
    • Drug: Placebo
    • Drug: Vofopitant
    • Drug: Lamotrigine
  • Experimental: Treatment sequence I
    Subjects on sequence I will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of lamotrigine 175 milligrams tablet + placebo in session A of part 2 and placebo + vofopitant 10 milligrams capsule in session B of part 2.
    Interventions:
    • Drug: Placebo
    • Drug: Vofopitant
    • Drug: Lamotrigine
  • Experimental: Treatment sequence J
    Subjects on sequence J will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of placebo + vofopitant 10 milligrams capsule in session A of part 2 and lamotrigine 175 milligrams tablet + placebo in session B of part 2.
    Interventions:
    • Drug: Placebo
    • Drug: Vofopitant
    • Drug: Lamotrigine
  • Experimental: Treatment sequence K
    Subjects on sequence K will receive single dose of placebo in part 1, single doses of lamotrigine 175 milligrams tablet + placebo in session A of part 2 and placebo + vofopitant 10 milligrams capsule in session B of part 2.
    Interventions:
    • Drug: Placebo
    • Drug: Vofopitant
    • Drug: Lamotrigine
  • Experimental: Treatment sequence L
    Subjects on sequence L will receive single dose of placebo in part 1, single doses of placebo + vofopitant 10 milligrams capsule in session A of part 2 and lamotrigine 175 milligrams tablet + placebo in session B of part 2.
    Interventions:
    • Drug: Placebo
    • Drug: Vofopitant
    • Drug: Lamotrigine
  • Experimental: Treatment sequence M
    Subjects on sequence M will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of lamotrigine 175 milligrams tablet + placebo in session A of part 2 and placebo + placebo in session B of part 2.
    Interventions:
    • Drug: Placebo
    • Drug: Vofopitant
    • Drug: Lamotrigine
  • Experimental: Treatment sequence N
    Subjects on sequence N will receive single dose of vofopitant 10 milligrams capsule in part 1, placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + placebo in session B of part 2.
    Interventions:
    • Drug: Placebo
    • Drug: Vofopitant
    • Drug: Lamotrigine
  • Experimental: Treatment sequence O
    Subjects on sequence O will receive placebo in part 1, single doses of lamotrigine 175 milligrams tablet + placebo in session A of part 2 and placebo + placebo in session B of part 2.
    Interventions:
    • Drug: Placebo
    • Drug: Vofopitant
    • Drug: Lamotrigine
  • Experimental: Treatment sequence P
    Subjects on sequence P will receive placebo in part 1, single doses of placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + placebo in session B of part 2.
    Interventions:
    • Drug: Placebo
    • Drug: Vofopitant
    • Drug: Lamotrigine
  • Experimental: Treatment sequence Q
    Subjects on sequence Q will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of lamotrigine 175 milligrams tablet + lamotrigine 150 milligrams tablet in session A of part 2 and placebo + placebo in session B of part 2.
    Interventions:
    • Drug: Placebo
    • Drug: Vofopitant
    • Drug: Lamotrigine
  • Experimental: Treatment sequence R
    Subjects on sequence R will receive single dose of vofopitant 10 milligrams capsule in part 1, single doses of placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + lamotrigine 150 milligrams tablet in session B of part 2.
    Interventions:
    • Drug: Placebo
    • Drug: Vofopitant
    • Drug: Lamotrigine
  • Experimental: Treatment sequence S
    Subjects on sequence S will receive placebo in part 1, single doses of lamotrigine 175 milligrams tablet + lamotrigine 150 milligrams tablet in session A of part 2 and placebo + placebo in session B of part 2.
    Interventions:
    • Drug: Placebo
    • Drug: Vofopitant
    • Drug: Lamotrigine
  • Experimental: Treatment sequence T
    Subjects on sequence T will receive placebo in part 1, single doses of placebo + placebo in session A of part 2 and lamotrigine 175 milligrams tablet + lamotrigine 150 milligrams tablet in session B of part 2.
    Interventions:
    • Drug: Placebo
    • Drug: Vofopitant
    • Drug: Lamotrigine
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 Terminated
Actual Enrollment  ICMJE
 (submitted: March 31, 2011)
12
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2009)
44
Actual Study Completion Date  ICMJE June 10, 2010
Actual Primary Completion Date June 10, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy subject
  • Male aged 18-65
  • Greater than 50kg weight
  • BMI 19-29.9 kg/m2

Exclusion Criteria:

  • Positive drug/alcohol screen
  • Positive HIV antibody
  • History of drug dependence
  • History of neurological disease
  • Pacemaker
  • Smoker
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00907985
Other Study ID Numbers  ICMJE 112676
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date July 2017

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