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
Status and phase
Terminated
Phase 1
Conditions
Bipolar Disorder
Treatments
Drug: Vofopitant
Drug: Placebo
Drug: Lamotrigine
Details and patient eligibility
About
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
- Assess the effects of drug A and drug B on muscle movement after brain stimulation;
- Examine how the body handles (absorbs, distributes, breaks down and gets rid of) drug A and drug B when given in combination;
- Examine the safety of drug A and drug B when given together.
Enrollment
12 patients
Sex
Male
Ages
18 to 65 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
12 participants in 20 patient groups
Treatment sequence A
Experimental group
Description:
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.
Treatment:
Drug: Lamotrigine
Drug: Placebo
Drug: Vofopitant
Treatment sequence B
Experimental group
Description:
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.
Treatment:
Drug: Lamotrigine
Drug: Placebo
Drug: Vofopitant
Treatment sequence C
Experimental group
Description:
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.
Treatment:
Drug: Lamotrigine
Drug: Placebo
Drug: Vofopitant
Treatment sequence D
Experimental group
Description:
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.
Treatment:
Drug: Lamotrigine
Drug: Placebo
Drug: Vofopitant
Treatment sequence E
Experimental group
Description:
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.
Treatment:
Drug: Lamotrigine
Drug: Placebo
Drug: Vofopitant
Treatment sequence F
Experimental group
Description:
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.
Treatment:
Drug: Lamotrigine
Drug: Placebo
Drug: Vofopitant
Treatment sequence G
Experimental group
Description:
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.
Treatment:
Drug: Lamotrigine
Drug: Placebo
Drug: Vofopitant
Treatment sequence H
Experimental group
Description:
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.
Treatment:
Drug: Lamotrigine
Drug: Placebo
Drug: Vofopitant
Treatment sequence I
Experimental group
Description:
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.
Treatment:
Drug: Lamotrigine
Drug: Placebo
Drug: Vofopitant
Treatment sequence J
Experimental group
Description:
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.
Treatment:
Drug: Lamotrigine
Drug: Placebo
Drug: Vofopitant
Treatment sequence K
Experimental group
Description:
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.
Treatment:
Drug: Lamotrigine
Drug: Placebo
Drug: Vofopitant
Treatment sequence L
Experimental group
Description:
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.
Treatment:
Drug: Lamotrigine
Drug: Placebo
Drug: Vofopitant
Treatment sequence M
Experimental group
Description:
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.
Treatment:
Drug: Lamotrigine
Drug: Placebo
Drug: Vofopitant
Treatment sequence N
Experimental group
Description:
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.
Treatment:
Drug: Lamotrigine
Drug: Placebo
Drug: Vofopitant
Treatment sequence O
Experimental group
Description:
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.
Treatment:
Drug: Lamotrigine
Drug: Placebo
Drug: Vofopitant
Treatment sequence P
Experimental group
Description:
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.
Treatment:
Drug: Lamotrigine
Drug: Placebo
Drug: Vofopitant
Treatment sequence Q
Experimental group
Description:
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.
Treatment:
Drug: Lamotrigine
Drug: Placebo
Drug: Vofopitant
Treatment sequence R
Experimental group
Description:
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.
Treatment:
Drug: Lamotrigine
Drug: Placebo
Drug: Vofopitant
Treatment sequence S
Experimental group
Description:
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.
Treatment:
Drug: Lamotrigine
Drug: Placebo
Drug: Vofopitant
Treatment sequence T
Experimental group
Description:
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.
Treatment:
Drug: Lamotrigine
Drug: Placebo
Drug: Vofopitant
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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