Effect of BIA 9-1067 on the Pharmacokinetics of Repaglinide

Effect of BIA 9-1067 on the Pharmacokinetics of Repaglinide in Healthy Volunteers

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

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: BIA 9-1067; Drug: Repaglinide

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• Portugal
  • S. Mamede do Coronado, Portugal, 4745-457
    • Bial - Portela & Cª, S.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Period 1: BIA 9-1067 + repaglinide Period 2: Repaglinide	Drug: BIA 9-1067; 25 mg BIA 9-1067 (single-dose); Other Names: OPC, Opicapone; Drug: Repaglinide; 0.5 mg repaglinide (single-dose); Other Names: Novonorm®
Experimental: Group 2; Period 1: Repaglinide Period 2: BIA 9-1067 + repaglinide	Drug: BIA 9-1067; 25 mg BIA 9-1067 (single-dose); Other Names: OPC, Opicapone; Drug: Repaglinide; 0.5 mg repaglinide (single-dose); Other Names: Novonorm®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax - Maximum Observed Plasma Concentration	pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.

Secondary Outcome Measures

Outcome Measure	Time Frame
Tmax - Time of Occurrence of Cmax	pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.
AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration	pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.
AUC0-∞ - Area Under the Plasma Concentration-time Curve From Time 0 to Infinity	pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.

Collaborators and Investigators

• Sponsor: Bial - Portela C S.A.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: January 23, 2012
• First Submitted That Met QC Criteria: February 16, 2012
• First Posted (Estimate): February 22, 2012

Study Record Updates

• Last Update Posted (Estimate): August 20, 2015
• Last Update Submitted That Met QC Criteria: July 22, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Parkinson Disease; BIA 9-1067
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antiparkinson Agents; Anti-Dyskinesia Agents; Catechol O-Methyltransferase Inhibitors; Opicapone; Repaglinide
• Other Study ID Numbers: BIA-91067-115