A Study to Investigate the Bioequivalence of Lacosamide 200mg Administered as Intravenous Solution and Oral Tablet in Healthy Chinese Male Subjects

NCT03204474 | Completed Phase 1

• 1 other identifier: SP1043
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the bioequivalence of a 200 mg single dose Lacosamide (LCM) intravenous (iv) solution with a 200 mg single dose LCM oral tablet in healthy Chinese male subjects.

Conditions

Healthy Male Chinese Volunteers

Keywords

Lacosamide; Bioequivalence; Intravenous solution; Tablet

Outcome Measures

Primary Outcomes (3)

• Maximum plasma concentration (Cmax) of Lacosamide (LCM)

  Blood samples will be taken at indicated time points to determine maximum Lacosamide (LCM) plasma concentration.

  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 LCM plasma concentration-time curve from time zero up to the time of last quantifiable concentration (AUC[0-t])

  Area under the LCM plasma concentration-time curve from time zero up to the last quantifiable concentration data point, computed using the log-linear trapezoidal rule.

  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 LCM plasma concentration-time curve extrapolated to infinity (AUC)

  Area under the LCM plasma concentration-time curve extrapolated to infinity calculated as AUC(0-t) + t/z, where t is the estimated plasma concentration at time t and z the terminal elimination rate constant.

  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 (6)

• Terminal plasma elimination half-life (t1/2) of LCM

  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) of LCM

  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 plasma clearance (CL/F) of LCM

  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) of LCM

  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

• Plasma clearance (CL) of LCM

  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

Study Arms (2)

Treatment A - B

EXPERIMENTAL

Single administration of the reference drug (Treatment A, a single dose of Lacosamide (LCM) 200 mg administered as 2 oral tablets \[100 mg each\]), 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 200 mg administered as intravenous infusion)

Drug: Lacosamide (LCM) tablet; Drug: Lacosamide (LCM) solution for infusion

Treatment B - A

EXPERIMENTAL

Single administration of the test drug (Treatment B, a single dose of LCM 200 mg administered as intravenous infusion), 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) 200 mg administered as 2 oral tablets \[100 mg each\])

Drug: Lacosamide (LCM) tablet; Drug: Lacosamide (LCM) solution for infusion

Interventions

Lacosamide (LCM) tablet DRUG

Treatment A: Single dose of Lacosamide (LCM) 200 mg given as 2 tablets of LCM 100 mg

Also known as: Vimpat

Treatment A - B; Treatment B - A

Lacosamide (LCM) solution for infusion DRUG

Treatment B: Single dose of Lacosamide (LCM) 200 mg administered as intravenous infusion

Also known as: Vimpat

Treatment A - B; Treatment B - A

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is a Chinese male between 18 and 40 years of age
• Subject has no clinically significant cardiovascular, renal, gastrointestinal, hepatic, metabolic, endocrine, neurological, or psychiatric abnormalities and is in general good health
• Subject confirms that during the study and for a period of 3 months after the final dose of study drug, when having sexual intercourse with a woman of childbearing potential, an acceptable birth control method will be used

You may not qualify if:

• Clinically relevant
• out of range values for hematology and clinical chemistry variables
• abnormality in physical examination or vital signs
• ECG finding
• Any clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study

Sponsors & Collaborators

• UCB Biopharma S.P.R.L.: lead

Study Sites (1)

Sp1043 001

Shanghai, China

Location

MeSH Terms

Interventions

Lacosamide; Solutions

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pharmaceutical Preparations

Study Officials

• UCB Cares

  UCB (+1 844 599 2273)

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 2, 2017
• Study Start: June 8, 2017
• Primary Completion: July 28, 2017
• Study Completion: July 28, 2017
• Last Updated: August 2, 2017

Record last verified: 2017-08

Locations

CN (1)