Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01679002
• Date of registration: 31/08/2012
• Prospective Registration: No
• Primary sponsor: Bial - Portela C S.A.
• Public title: Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers
• Scientific title: Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers
• Date of first enrolment: October 2003
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01679002
• Study type: Interventional
• Phase: Phase 1

Countries of recruitment

Portugal

Contacts

• Name: Manuel Vaz-da-Silva, MD, PhD
• Affiliation: BIAL - Portela & Cª S.A.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects were eligible for entry into the study if they fulfilled the following
inclusion criteria:

- 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 clinically acceptable.

- 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 and first
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.

- If case of female subjects, subjects who were not of childbearing potential by reason
of surgery or, if of childbearing potential, who used one of the following methods of
contraception: double-barrier, intrauterine device or abstinence.

- If case of female subjects, subjects who had a negative pregnancy test at screening
and first admission.

Exclusion Criteria:

- Subjects who did not conform to the above inclusion criteria.

- Subjects who had 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 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 hypersensitivity to carbamazepine or oxcarbazepine or
any other relevant drug hypersensitivity.

- Subjects who had a history of alcoholism or drug abuse.

- Subjects who consumed more than 14 units of alcohol a week.

- Subjects who had a significant infection or known inflammatory process on screening
and/or first admission.

- Subjects who had acute gastrointestinal symptoms at the time of screening and/or first
admission (e.g., nausea, vomiting, diarrhoea, heartburn).

- Subjects who had used prescription or over-the-counter medication within two weeks of
first admission.

- Subjects who had used any investigational drug and/or participated in any clinical
trial within four 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 4 months prior to screening.

- Subjects who were vegetarians, vegans and/or have medical dietary restrictions.

- Subjects who could not communicate reliably with the investigator.

- Subjects who were unlikely to co-operate with the requirements of the study.

- Subjects who were unwilling or unable to give written informed consent.

- In case of female subjects, subjects who were pregnant or breast-feeding.

- In case of female subjects, subjects who were of childbearing potential and did not
use an approved effective contraceptive method or used oral contraceptives.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Epilepsy

Intervention(s)

Drug: BIA 2-093

Drug: Oxcarbazepine

Primary Outcome(s)

Cmax - Maximum Observed Plasma Drug Concentration [Time Frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose]

Secondary Outcome(s)

AUC - Area Under the Plasma Concentration Versus Time Curve [Time Frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose]

Number of of Subjects Reporting at Least One Adverse Event [Time Frame: 8 weeks]

Secondary ID(s)

BIA-2093-110

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 01/01/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01679002