Crossover Study of Neuropsychological Effects of Lacosamide and Carbamazepine Immediate Release in Healthy Subjects

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this Phase 1 crossover study is to evaluate the neuropsychological effects of Lacosamide (LCM) compared to Carbamazepine Immediate Release (CBZ-IR) after administration in healthy subjects. Safety, tolerability, and pharmacokinetic data will also be collected.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: UCB Pharma
• Treatments: Carbamazepine; Lacosamide

Criteria

Inclusion Criteria:

• Subjects are between 18 and 55 years of age (inclusive)

• Subjects have a Body Mass Index (BMI) between 18 and 35 kg/m^2 (inclusive)

• Subjects must be in generally good health with no clinically relevant health conditions

Exclusion Criteria:

• Subject has previously been randomized in this study or subject has received LCM or CBZ

• Subjects may not currently be participating in or have participated in the past 30 days in a clinical drug or device study

• Subjects may not have a history of drug or alcohol abuse within the last 2 years

• Subjects may not consume more than 40 g of alcohol per day

• Females who are pregnant or nursing are ineligible; females of childbearing potential must agree to adhere to protocol conception guidelines

• Subjects may not score ≤ 70 on the Peabody Picture Vocabulary Test (PPVT)

• Subjects with a lifetime history of suicide attempt or suicidal ideation in the past 6 months may not participate

• Subjects with a diet that deviates notably from the normal amounts of protein, carbohydrate, and fat, as judged by the investigator are ineligible to participate

• Subjects may not consume more than 600 mg of caffeine/day

• Subjects may not smoke more than 10 cigarettes per day or have done so within 6 months prior to Screening

• Subjects may not have a positive alcohol breath test or urine drug screen at Screening