Open-label Drug Interaction Study Between Eslicarbazepine Acetate and Phenytoin.

NCT02283827 | Completed Phase 1 Results

• 1 other identifier: BIA-2093-121
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

Single centre, open-label, multiple doses, two parallel study groups each receiving two formulations in a one-sequence design

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Cmax - the Maximum Plasma Concentration

  BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate

  Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration

Secondary Outcomes (2)

• AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time

  Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration

• Tmax - the Time of Occurrence of Cmax

  Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration

Study Arms (2)

Group A BIA 2-093 + Phenytoin (PHT)

EXPERIMENTAL

Day 1 to 2: Pre-treatment 1: 600 mg ESL Day 3 to 8: Treatment 1: 1200 mg ESL Day 9 to 10: Treatment 1 + Pre-treatment 2: 1200 mg ESL+ 100 mg PHT Day 11 to 27: Treatment 1 + Treatment 2: 1200 mg ESL + 300 mg PHT

Drug: BIA 2-093; Drug: Phenytoin

Group B BIA 2-093 + Phenytoin (PHT)

EXPERIMENTAL

Day 1 to 2: Pre-treatment 2: 100 mg PHT Day 3 to 8: Treatment 2: 300 mg PHT Day 9 to 10: Treatment 2 + Pre-treatment 1: 300 mg PHT + 600 mg ESL Day 11 to 27: Treatment 1 + Treatment 2: 1200 mg ESL + 300 mg PHT

Drug: BIA 2-093; Drug: Phenytoin

Interventions

BIA 2-093 DRUG

Also known as: Eslicarbazepine acetate, ESL

Group A BIA 2-093 + Phenytoin (PHT); Group B BIA 2-093 + Phenytoin (PHT)

Phenytoin DRUG

Also known as: PHT

Group A BIA 2-093 + Phenytoin (PHT); Group B BIA 2-093 + Phenytoin (PHT)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer
• Non-black male aged of at least 18 years but not older than 45 years with a body mass index (BMI) greater than or equal to 19 and below 30 kg/m2
• Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance (laboratory tests are presented in section 6.1.1.3)
• Healthy according to the medical history, laboratory results and physical examination
• Light-, non- or ex-smokers. A light smoker is defined as someone smoking 10 cigarettes or less per day, and an ex-smoker is defined as someone who completely stopped smoking for at least 12 months before day 1 of this study

You may not qualify if:

• Significant history of hypersensitivity to phenytoin, eslicarbazepine, oxcarbazepine, carbamazepine or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
• Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
• History of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability, including but not limited to cholecystectomy
• Presence of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease
• Presence of significant heart disease or disorder according to ECG
• Presence or history of significant central nervous system disorder like convulsion or depression
• Hemoglobin count below 135 g/L (at screening)
• Use of valproic acid in the previous 7 days prior to Day 1 of the study.
• Maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse (\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
• Any clinically significant illness in the previous 28 days before day 1 of this study
• Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids,phenytoin and rifampin), in the previous 28 days before Day 1 of this study.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

MeSH Terms

Conditions

Epilepsy

Interventions

eslicarbazepine acetate; Phenytoin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Hydantoins; Imidazolidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Head of Clinical Research
• Organization: Bial - Portela & Cª, S.A.

jose.rocha@bial.com

+351 229 866 100

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 5, 2014
• Study Start: January 1, 2007
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: December 18, 2014
• Results First Posted: December 18, 2014

Record last verified: 2014-12