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Completed

NCT Number: NCT03204474

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

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.

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Key information

Conditions

Healthy Male Chinese Volunteers

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Sp1043 001

Shanghai, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Lacosamide (LCM) tablet

Drug

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

Other names: Vimpat

Lacosamide (LCM) solution for infusion

Drug

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

Other names: Vimpat

Primary outcomes

  1. Maximum plasma concentration (Cmax) of Lacosamide (LCM)

    Time frame: 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

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

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

    Time frame: 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 last quantifiable concentration data point, computed using the log-linear trapezoidal rule.

  3. Area under the LCM plasma concentration-time curve extrapolated to infinity (AUC)

    Time frame: 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 calculated as AUC(0-t) + t/z, where t is the estimated plasma concentration at time t and z the terminal elimination rate constant.

Secondary outcomes

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

    Time frame: 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

    Terminal elimination half-life of LCM, reported in hours, as determined via simple linear regression (slope=-z) of natural log (ln) concentration vs time for data points in the terminal phase of the concentration-time curve. t½ is calculated as ln(2)/z.

  2. Time of observed Cmax (tmax) of LCM

    Time frame: 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 will be obtained directly from the plasma concentration-time curves.

  3. Apparent plasma clearance (CL/F) of LCM

    Time frame: 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 calculated as CL/F=Dose/AUC. CL/F will be calculated for the oral tablet formulation only

  4. Apparent volume of distribution (Vz/F) of LCM

    Time frame: 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, calculated as Vz/F=(CL/F)/z. Vz/F will be calculated for the oral tablet formulation only

  5. Plasma clearance (CL) of LCM

    Time frame: 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, calculated as CL=Dose/AUC. CL will be calculated for the iv formulation only.

  6. Volume of distribution (Vz) of LCM

    Time frame: 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

    Volume of distribution, calculated as Vz=CL/z. Vz will be calculated for the iv formulation only.

Sponsors and collaborators

Lead sponsor

UCB Biopharma S.P.R.L.

Industry

Registry information

Official study title

A Randomized, Open-Label, Single-Dose, 2-Way Crossover Study to Investigate the Bioequivalence of Lacosamide 200mg Administered as Intravenous Solution and Oral Tablet in Healthy Chinese Male Subjects

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 2, 2017
Registry last updated
Aug 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.