Overview

Effect of BIA 9-1067 on the Pharmacokinetics of Repaglinide

Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to investigate the CYP2C8 inhibition by BIA 9-1067.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Bial - Portela C S.A.
Treatments:
Opicapone
Repaglinide
Criteria
Inclusion Criteria:

- Able and willing to give written informed consent.

- Male or female subjects aged between 18 and 45 years, inclusive.

- Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.

- Healthy as determined by pre-study medical history, physical examination, vital signs,
complete neurological examination and 12-lead ECG.

- Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening.

- Clinical laboratory test results clinically acceptable at screening and admission to
each treatment period.

- Negative screen for alcohol and drugs of abuse at screening and admission to each
treatment period.

- Non-smokers or ex-smokers for at least 3 months.

- (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: double
barrier or intrauterine device.

- (If female) She had a negative urine pregnancy test at screening and admission to each
treatment period.

Exclusion Criteria:

- 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.

- Clinically relevant surgical history.

- Any abnormality in the coagulation tests.

- Any abnormality in the liver function tests.

- A history of relevant atopy or drug hypersensitivity.

- History of alcoholism or drug abuse.

- Consumed more than 14 units of alcohol a week.

- Significant infection or known inflammatory process at screening or admission to each
treatment period.

- Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the
time of screening or admission to each treatment period.

- Had used medicines within 2 weeks of admission to first period that may have affected
the safety or other study assessments, in the investigator's opinion.

- Had previously received BIA 9-1067.

- Had used any investigational drug or participated in any clinical trial within 6
months prior to screening.

- Had participated in more than 2 clinical trials within the 12 months prior to
screening.

- Had donated or received any blood or blood products within the 3 months prior to
screening.

- Vegetarians, vegans or had medical dietary restrictions.

- Cannot communicate reliably with the investigator.

- Unlikely to co-operate with the requirements of the study.

- Unwilling or unable to gave written informed consent.

- Employees at BIAL - Portela & CÂȘ, S.A.

- (If female) She was pregnant or breast-feeding.

- (If female) She was of childbearing potential and she did not used an approved
effective contraceptive method (double-barrier or intra-uterine device) or she used
oral contraceptives.