Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers

NCT01678976 | Completed Phase 1 Results

• 1 other identifier: BIA-2093-104
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the pharmacokinetics of a single 900 mg oral dose of BIA 2-093 and a single 900 mg oral dose of Oxcarbazepine in healthy volunteers and to assess the tolerability of a single 900 mg dose of BIA 2-093 and Oxcarbazepine.

Conditions

Epilepsy

Keywords

Eslicarbazepine acetate; Epilepsy; Oxcarbazepine

Outcome Measures

Primary Outcomes (1)

• Maximum Drug Concentration (Cmax)

  Maximum observed plasma concentration (Cmax) was acessed for BIA 2-093 metabolites (BIA 2-194; BIA 2-195) and Oxcarbazepine.

  at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose

Secondary Outcomes (1)

• Area Under the Plasma Concentration Versus Time Curve (AUC)

  at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose

Other Outcomes (1)

• Total of Subjects Reporting at Least One Adverse Event

  4 weeks

Study Arms (2)

Group 1 BIA 2-093 + Oxcarbazepine

EXPERIMENTAL

Period 1 - Subjects recieved 900 mg of BIA 2-093 Period 2 - Subjects recieved 900 mg of oxcarbazepine

Drug: BIA 2-093; Drug: Oxcarbazepine

Group 2 Oxcarbazepine + BIA 2-093

ACTIVE COMPARATOR

Period 1 - Subjects recieved 900 mg of oxcarbazepine Period 2 - Subjects recieved 900 mg of BIA 2-093

Drug: BIA 2-093; Drug: Oxcarbazepine

Interventions

BIA 2-093 DRUG

Tablets containing BIA 2-093 in doses of 300 and 600 mg

Also known as: Eslicarbazepine acetate

Group 1 BIA 2-093 + Oxcarbazepine; Group 2 Oxcarbazepine + BIA 2-093

Oxcarbazepine DRUG

Tablets containing 300 mg and 600 mg of Trileptal®

Also known as: Trileptal®

Group 1 BIA 2-093 + Oxcarbazepine; Group 2 Oxcarbazepine + BIA 2-093

Eligibility Criteria

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

You may qualify if:

• Male or female subjects aged between 18 and 45 years, inclusive.
• Subjects of body mass index (BMI) between 19 and 28 kg/m2, inclusive.
• Subjects who were healthy as determined by pre-study medical history, physical examination, neurological examination, and 12-lead ECG.
• Subjects who had clinical laboratory tests acceptable.
• Subjects who were negative for HBs Ag, anti-HCV Ab and HIV-1 and HIV-2 Ab tests at screening.
• Subjects who were negative for alcohol and drugs of abuse at screening and admission.
• Subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per day.
• Subjects who were able and willing to give written informed consent.
• In case of female volunteers, subjects who were not of childbearing potential by reason of surgery or, if of childbearing potential, used one of the following methods of contraception: double-barrier, intrauterine device or abstinence.
• In case of female volunteers, subjects who had a negative pregnancy test at screening and admission

You may not qualify if:

• Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders.
• Subjects who had a clinically relevant surgical history.
• Subjects who had a clinically relevant family history.
• Subjects who had a history of relevant atopy.
• Subjects who had a history of relevant drug hypersensitivity.
• Subjects who had a history of alcoholism or drug abuse.
• Subjects who consumed more than 21 units of alcohol a week.
• Subjects who had a significant infection or known inflammatory process on screening and/or admission.
• Subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g., nausea, vomiting, diarrhoea, heartburn).
• Subjects who had used prescription drugs within 4 weeks of first dosing.
• Subjects who had used over-the-counter medication excluding oral routine vitamins but including mega dose vitamin therapy within one week of first dosing.
• Subjects who had used any investigational drug and/or participated in any clinical trial within 2 months of their first admission.
• Subjects who had previously received BIA 2-093.
• Subjects who had donated and/or received any blood or blood products within the previous 2 months prior to screening.
• Subjects who were vegetarians, vegans and/or had medical dietary restrictions.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

BIAL - Portela & Cª - Human Pharmacology Unit (UFH)

S. Mamede Do Coronado, Trofa, 4745-457, Portugal

Location

MeSH Terms

Conditions

Epilepsy

Interventions

eslicarbazepine acetate; Oxcarbazepine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Carbamazepine; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

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

francisco.rocha@bial.com

+351 229 866 100

Study Officials

• Manuel Vaz-da-Silva, MD, PhD

  BIAL - Portela & Cª S.A

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: August 31, 2012
• First Posted: September 5, 2012
• Study Start: March 1, 2002
• Primary Completion: April 1, 2002
• Study Completion: April 1, 2002
• Last Updated: January 8, 2015
• Results First Posted: January 8, 2015

Record last verified: 2014-12

Locations

PT (1)