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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

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Placebo Drug: Vofopitant Drug: Lamotrigine Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 15, 2009
Actual Primary Completion Date : June 10, 2010
Actual Study Completion Date : June 10, 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Lamotrigine

Arm Intervention/treatment
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.
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.




Primary Outcome Measures :
  1. Effect of the study treatments on Resting Motor Thresholds (rMT) [ Time Frame: Within 24 hours ]

Secondary Outcome Measures :
  1. The safety and tolerability of the combination of study treatments. [ Time Frame: Within 24 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00907985


Locations
Germany
GSK Investigational Site
Goettingen, Niedersachsen, Germany, 37075
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 112676
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 112676
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 112676
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 112676
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 112676
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 112676
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 112676
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00907985     History of Changes
Other Study ID Numbers: 112676
First Posted: May 25, 2009    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
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.
URL: http://

Keywords provided by GlaxoSmithKline:
Healthy Volunteer
Resting motor threshold (rMT)
Transcranial magnetic stimulation (TMS)

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Lamotrigine
Anticonvulsants
Vofopitant
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists