A Phase 1 interventional study of Placebo and Vofopitant in Bipolar Disorder, sponsored by GlaxoSmithKline. Terminated at 1 site in Germany. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-21.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
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
1,602 studies on the registry are indexed under Bipolar Disorder; 255 are open to participants now.
This study's enrollment of 12 is below the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →GlaxoSmithKline is the lead sponsor of 3,561 studies on the registry; 116 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
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Exclusion Criteria:
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 · Drug: Vofopitant · Drug: Lamotrigine
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 · Drug: Vofopitant · Drug: Lamotrigine
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 · Drug: Vofopitant · Drug: Lamotrigine
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 · Drug: Vofopitant · Drug: Lamotrigine
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 · Drug: Vofopitant · Drug: Lamotrigine
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 · Drug: Vofopitant · Drug: Lamotrigine
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 · Drug: Vofopitant · Drug: Lamotrigine
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 · Drug: Vofopitant · Drug: Lamotrigine
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 · Drug: Vofopitant · Drug: Lamotrigine
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 · Drug: Vofopitant · Drug: Lamotrigine
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 · Drug: Vofopitant · Drug: Lamotrigine
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 · Drug: Vofopitant · Drug: Lamotrigine
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 · Drug: Vofopitant · Drug: Lamotrigine
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 · Drug: Vofopitant · Drug: Lamotrigine
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 · Drug: Vofopitant · Drug: Lamotrigine
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 · Drug: Vofopitant · Drug: Lamotrigine
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 · Drug: Vofopitant · Drug: Lamotrigine
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 · Drug: Vofopitant · Drug: Lamotrigine
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 · Drug: Vofopitant · Drug: Lamotrigine
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 · Drug: Vofopitant · Drug: Lamotrigine
Single dose of placebo will be provided.
Vofopitant (GR205171) will be provided as 5 milligram single dose capsule administered orally. It will be available as swedish orange, size 0 capsules.
Lamotrigine will be provided as 25 milligrams or 100 milligrams single dose dispersible tablet administered orally.
Effect of the study treatments on Resting Motor Thresholds (rMT)
Time frame: Within 24 hours
The safety and tolerability of the combination of study treatments.
Time frame: Within 24 hours
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
This study is terminated, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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