NCT02972125

Brief Summary

This is a study designed to demonstrate the Bioequivalence between Lacosamide (LCM) Tablet and Dry Syrup in Healthy Male Japanese Subjects

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 10, 2017

Status Verified

March 1, 2017

Enrollment Period

4 months

First QC Date

November 21, 2016

Last Update Submit

March 9, 2017

Conditions

Healthy Volunteers

Keywords

LacosamideBioequivalenceDry Syrup

Outcome Measures

Primary Outcomes (2)

  • Maximum concentration (Cmax)

    Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing

  • Area under the curve from 0 to time of last quantifiable concentration (AUC(0-t))

    Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing

Secondary Outcomes (7)

  • Area under the curve from zero up to infinity (AUC)

    Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing

  • Apparent total body clearance (CL/F)

    Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing

  • Apparent volume of distribution (Vz/F)

    Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing

  • Mean residence time (MRT)

    Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing

  • Time of observed Cmax (tmax)

    Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing

  • +2 more secondary outcomes

Study Arms (2)

Treatment A - B

EXPERIMENTAL

Single administration of the reference drug (Treatment A, a single dose of Lacosamide (LCM) 100 mg tablet), followed by a Wash-Out Period of at least 7 days and a single administration of the test drug (Treatment B, a single dose of LCM 100 mg given as dry syrup).

Drug: Lacosamide (LCM) tabletDrug: Lacosamide (LCM) dry syrup

Treatment B - A

EXPERIMENTAL

Single administration of the test drug (Treatment B, a single dose of LCM 100 mg given as dry syrup), followed by a Wash-Out Period of at least 7 days and a single administration of the reference drug (Treatment A, a single dose of Lacosamide (LCM) 100 mg tablet).

Drug: Lacosamide (LCM) tabletDrug: Lacosamide (LCM) dry syrup

Interventions

Lacosamide (LCM) tabletDRUG

Treatment A: Single dose of Lacosamide (LCM) 100 mg tablet

Treatment A - BTreatment B - A
Lacosamide (LCM) dry syrupDRUG

Treatment B: Single dose of Lacosamide (LCM) 100 mg given as dry syrup

Treatment A - BTreatment B - A

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subject is male and between 20 and 55 years of age (inclusive)
  • Subject is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a subject has all 4 Japanese grandparents born in Japan)
  • Male subject confirms that when having sexual intercourse with a woman of childbearing potential, he will use condoms during the study and 1 week after the last dose of study drug

You may not qualify if:

  • Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study.
  • Subject has clinically relevant out-of-range values for hematology, and serum chemistry, or urinalysis variables at the Screening Visit.
  • Subject has any clinically significant abnormal physical examination (Screening Visit or Day -1) and vital signs (Screening Visit).
  • Subject has any clinically relevant ECG finding at the Screening Visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ep0059 001

London, United Kingdom

Location

MeSH Terms

Interventions

Lacosamide

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic Acids

Study Officials

  • UCB Cares

    +1 877 822 9493 (UCB)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2016

First Posted

November 23, 2016

Study Start

November 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

March 10, 2017

Record last verified: 2017-03

Locations

GB(1)