Single-dose Pharmacokinetics and Relative Bioavailability of an Oral Suspension and Two Tablet Formulations of BIA 2-093

NCT02279667 | Completed Phase 1 Results

• 1 other identifier: BIA-2093-109
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Single centre, open-label, randomised, three-way crossover study in 18 healthy subjects (9 males and 9 females). The study consisted of three consecutive single-dose treatment periods separated by a washout period of 7 days or more. On each treatment period, the volunteers received a single dose of BIA 2-093 800 mg, orally.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (4)

• Cmax - the Maximum Plasma Concentration

  Cmax - the maximum plasma concentration of BIA 2-093 metabolite: BIA 2-005

  Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose

• Tmax - the Time of Occurrence of Cmax

  Tmax - the Time of Occurrence of maximum plasma concentration of BIA 2-093 metabolite: BIA 2-005

  Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose

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

  AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time of BIA 2-093 metabolite: BIA 2-005

  Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose

• AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity

  AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity of BIA 2-093 metabolite: BIA 2-005

  Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose

Study Arms (3)

Group A

EXPERIMENTAL

1. st period - 16 mL oral suspension 50 mg/mL 2. nd period - Four 200 mg tablets 3. rd period - One 800 mg tablet

Drug: BIA 2-093

Group B

EXPERIMENTAL

1. st period - One 800 mg tablet 2. nd period - 16 mL oral suspension 50 mg/mL 3. rd period - Four 200 mg tablets

Drug: BIA 2-093

Group C

EXPERIMENTAL

1. st period - Four 200 mg tablets 2. nd period - One 800 mg tablet 3. rd period - 16 mL oral suspension 50 mg/mL

Drug: BIA 2-093

Interventions

BIA 2-093 DRUG

oral suspension 50 mg/mL

Also known as: ESL, Eslicarbazepine acetate

Group A; Group B; Group C

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, vital signs and 12-lead ECG at screening.
• Subjects who had clinical laboratory tests clinically acceptable at screening.
• Subjects who were negative for HBsAg, 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.
• Subjects who were non-smokers or who smoke less than 10 cigarettes or equivalent per day.
• Subjects who were able and willing to give written informed consent.
• (If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: doublebarrier, intra-uterine device or abstinence.
• (If female) She had a negative pregnancy test at screening and admission to each study period.

You may not qualify if:

• Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
• Subjects who have a clinically relevant surgical history.
• Subjects who have a clinically relevant family history.
• Subjects who have a history of relevant atopy.
• Subjects who have a history of any drug hypersensitivity.
• Subjects who have a history of alcoholism or drug abuse.
• Subjects who consume more than 14 units of alcohol a week.
• Subjects who have a significant infection or known inflammatory process on screening and/or first admission.
• Subjects who have acute gastrointestinal symptoms at the time of screening and/or first admission (e.g., nausea, vomiting, diarrhoea, heartburn).
• Subjects who have used medicines within 2 weeks of admission to first period.
• Subjects who have participated in any clinical trial within 3 months prior to screening.
• Subjects who have previously received BIA 2-093.
• Subjects who have donated and/or received any blood or blood products within the previous 3 months prior to screening.
• Subjects who are vegetarians, vegans and/or have medical dietary restrictions.
• Subjects who cannot communicate reliably with the investigation team.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

CEB - Centre for Bioavailability Studies, AIBILI

Azinhaga de Santa Comba - Celas, Coimbra District, Portugal

Location

MeSH Terms

Conditions

Epilepsy

Interventions

eslicarbazepine acetate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

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: 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: October 29, 2014
• First Posted: October 31, 2014
• Study Start: February 1, 2004
• Primary Completion: March 1, 2004
• Study Completion: March 1, 2004
• Last Updated: January 1, 2015
• Results First Posted: January 1, 2015

Record last verified: 2014-12

Locations

PT (1)