Study to Evaluate the Pharmacokinetics, Safety, Tolerability of Single Dose Lacosamide in Subjects With Renal Impairment Compared to Healthy Subjects

NCT01796938 | Completed Phase 1

• 1 other identifier: SP0641
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

To investigate the Pharmacokinetics (PK) of oral administered Lacosamide in renal impaired subjects and healthy subjects.

Conditions

Healthy; Renal Impairment

Keywords

Lacosamide; Vimpat; Single Dose; Pharmacokinetics; Renal Impairment

Outcome Measures

Primary Outcomes (4)

• Area under the Lacosamide plasma concentration time curve from 0 to the last quantifiable data point (AUC(0-tz))

  Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; \> 24 hours excluded for group 5

  Day 1 to Day 5 of study

• Measured maximal concentration (Cmax) of Lacosamide

  Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; \> 24 hours excluded for group 5

  Day 1 to Day 5 of study

• Area under the Lacosamide plasma concentration-time curve from 0 to the last quantifiable data point (AUC (0-tz)), normalized by body weight

  Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; \> 24 hours excluded for group 5

  Day 1 to Day 5 of study

• Measured maximal concentration (Cmax, norm) of Lacosamide normalized by body weight

  Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; \> 24 hours excluded for group 5

  Day 1 to Day 5 of study

Secondary Outcomes (22)

• Time of observed maximum (tmax) of Lacosamide concentration

  Day 1 to Day 5 of study

• Time of observed maximum (tmax) of Lacosamide metabolite (SPM12809) concentration

  Day 1 to Day 5 of study

• Terminal half-life (t1/2) of Lacosamide

  Day 1 to Day 5 of study

• Terminal half-life (t1/2) of Lacosamide metabolite (SPM12809)

  Day 1 to Day 5 of study

• Apparent total clearance (CL/f) of Lacosamide from plasma

  Day 1 to Day 5 of study

Study Arms (5)

Group 1: Healthy subjects

EXPERIMENTAL

Single dose of 100 mg Lacosamide

Drug: Lacosamide tablet

Group 2: Subjects with mild renal insufficiency

EXPERIMENTAL

Single dose of 100 mg Lacosamide

Drug: Lacosamide tablet

Group 3: Subjects with moderate renal insufficiency

EXPERIMENTAL

Single dose of 100 mg Lacosamide

Drug: Lacosamide tablet

Group 4: Subjects with severe renal insufficiency

EXPERIMENTAL

Single dose of 100 mg Lacosamide

Drug: Lacosamide tablet

Group 5: Subjects with end stage renal insufficiency

EXPERIMENTAL

Single dose of 100 mg Lacosamide

Drug: Lacosamide tablet

Interventions

Lacosamide tablet DRUG

Single dose of 100 mg Lacosamide tablet

Also known as: Vimpat

Group 1: Healthy subjects; Group 2: Subjects with mild renal insufficiency; Group 3: Subjects with moderate renal insufficiency; Group 4: Subjects with severe renal insufficiency; Group 5: Subjects with end stage renal insufficiency

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject was informed and given ample time and opportunity to think about his/her participation and had given his/her written informed consent
• Subject was willing and able to comply with all trial requirements
• Subject was a male or female Caucasian, between 18 and 70 years of age (inclusive)
• If female, subject was of non-childbearing potential (post-menopausal or hysterectomized) or was using medically adequate contraception
• If female of childbearing potential, subject had a negative pregnancy test
• Subject had a Body Mass Index (BMI) between 20 and 34 kg/m2 (inclusive)
• Subject was healthy without clinically relevant cardiovascular, renal, gastrointestinal, hepatic, metabolic, endocrine, neurological, or psychiatric abnormalities detected during Eligibility Assessment (EA)
• Subject had no clinically relevant cardiovascular or endocrine findings during EA
• Subject had a renal impairment. The subjects were assigned to 1 of the following treatment groups according to Creatinine Clearance (CLCr) values determined 2 to 7 days prior to dosing:
• Group 2: 80 mL/min \> CLCr ≥ 50 mL/min (subjects with mild renal impairment)
• Group 3: 50 mL/min \> CLCr ≥ 30 mL/min (subjects with moderate renal impairment)
• Group 4: CLCr \< 30 mL/min (subjects with severe renal impairment, not on dialysis between 2 weeks before EA and end of the trial)
• Subject was informed and given ample time and opportunity to think about his/her participation and had given his/her written informed consent
• Subject was willing and able to comply with all trial requirements
• Subject was a male or female Caucasian, between 18 and 70 years of age (inclusive)

You may not qualify if:

• Healthy subjects:
• Subject had previously participated in this trial
• Subject had participated in another trial of an investigational product within the last 3 months or was currently participating in another trial of an investigational product
• Subject had donated blood or had a comparable blood loss (\> 500 mL) within the last 3 months prior to EA
• Subject smoked more than 5 cigarettes per day or had done so within the 6 months prior to commencement of this trial
• Subject had a history of chronic alcohol or drug abuse within the last 6 months prior to commencement of this trial
• Subject consumed more than 40 g of alcohol/day (amount corresponds to 1 L beer/day or 0.5 L wine/day or 120 mL liquor/day)
• Subject had positive tests for alcohol (urine or breath test) or drugs (urine test)
• Subject had clinically relevant changes in the electrocardiogram (ECG), such as second- or third-degree atrioventricular (AV) block, prolongation of the QRS complex over 120 ms or of the corrected QT (QTc) interval \> 430 ms (male subjects) or \> 450 ms (female subjects)
• Subject had a history or present condition of clinically relevant respiratory or cardiovascular disorders, eg, cardiac insufficiency, coronary heart disease, hypertension, arrhythmia, tachyarrhythmia, or status after myocardial infarction
• Subject had a history or present condition of psychic abnormality, psychiatric or neurologic illness, or autonomic neuropathy that, in the opinion of the Investigator, could have jeopardized or would have compromised the subject's ability to participate in the trial
• Subject had a history or present condition of seizure disorder
• Subject had a history or present condition of malignancy
• Subject had a history or present condition of renal disorders (albuminuria, chronic infections) or renal impairment
• Subject had a history or present condition of Diabetes Mellitus or thyroid dysfunction, especially Hyperthyreosis, or other endocrine disorders

Sponsors & Collaborators

• UCB BIOSCIENCES GmbH: lead

Study Sites (2)

1

Cologne, Germany

Location

2

Rendsburg, Germany

Location

Related Publications (1)

• Cawello W, Fuhr U, Hering U, Maatouk H, Halabi A. Impact of impaired renal function on the pharmacokinetics of the antiepileptic drug lacosamide. Clin Pharmacokinet. 2013 Oct;52(10):897-906. doi: 10.1007/s40262-013-0080-7.

  PMID: 23737404 DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Lacosamide

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2013
• First Posted: February 22, 2013
• Study Start: June 1, 2004
• Primary Completion: November 1, 2004
• Study Completion: November 1, 2004
• Last Updated: October 20, 2014

Record last verified: 2013-02

Locations

DE (2)