Effect of BIA 9-1067 on the Pharmacokinetics of Repaglinide

NCT ID: NCT01536366

Last Updated: 2015-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-01-31

Brief Summary

The purpose of this study is to investigate the CYP2C8 inhibition by BIA 9-1067.

Detailed Description

Single-centre, open-label, randomised, two-way crossover study in healthy young male and female volunteers

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Period 1: BIA 9-1067 + repaglinide Period 2: Repaglinide

Group Type: EXPERIMENTAL

BIA 9-1067

Intervention Type: DRUG

25 mg BIA 9-1067 (single-dose)

Repaglinide

Intervention Type: DRUG

0.5 mg repaglinide (single-dose)

Group 2

Period 1: Repaglinide Period 2: BIA 9-1067 + repaglinide

Group Type: EXPERIMENTAL

BIA 9-1067

Intervention Type: DRUG

25 mg BIA 9-1067 (single-dose)

Repaglinide

Intervention Type: DRUG

0.5 mg repaglinide (single-dose)

Interventions

BIA 9-1067

25 mg BIA 9-1067 (single-dose)

Intervention Type: DRUG

Repaglinide

0.5 mg repaglinide (single-dose)

Intervention Type: DRUG

Other Intervention Names

OPC, Opicapone; Novonorm®

Eligibility 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 & Cª, 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bial - Portela C S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manuel Vaz-da-Silva, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

BIAL - Portela & Cª S.A.

Locations

Bial - Portela & Cª, S.A.

S. Mamede Do Coronado, , Portugal

Countries

Portugal

Other Identifiers

BIA-91067-115

Identifier Type: -

Identifier Source: org_study_id