Comparative Bioavailability Study of BIA 9-1067 25 mg Capsules

Single Dose Crossover Comparative Bioavailability Study of BIA 9-1067 25 mg Capsules in Healthy Male Volunteers Following Administration of a 50 mg Dose / Fasted and Fed States

The objectives of this study were to characterize the effects of food on the pharmacokinetics (PK) and tolerability of BIA 9-1067 in healthy male subjects.

Study Overview

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

Detailed Description

Methodology: Single center, randomized, single dose, open-label, 2-period, 2-sequence, crossover study.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Mount-Royal, Quebec, Canada, H3P 3P1
      • Algorithme Pharma Inc.

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Availability for the entire study period and willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer
• Male volunteer
• Volunteer aged of at least 18 years but not older than 45 years
• Volunteer with a body mass index (BMI) greater than or equal to 18.5 and below 30 kg/m2
• Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance
• Healthy according to the medical history, laboratory results and physical examination
• Light-, non- or ex-smokers. A light smoker is defined as someone smoking 10 cigarettes or less per day for at least 3 months before day 1 of this study. An ex-smoker is defined as someone who completely stopped smoking for at least 12 months before day 1 of this study
• The informed consent form must be signed by all volunteers, prior to their participation in the study.

Exclusion Criteria:

• Volunteers presenting any of the following will not be included in the study:Significant history of hypersensitivity to any catechol-structured drugs (e.g. rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dopexamine or dobutamide) or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
• Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
• History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
• Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic, dermatologic or connective tissue disease
• Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases
• Presence of significant heart disease or disorder according to ECG
• Previous history of Neuroleptic Malignant Syndrome (NMS) and/or nontraumatic rhabdomyolysis
• Pheochromocytoma due to the increased risk of hypertensive crisis
• Use of MAO inhibitors within 14 days of day 1 of the study
• Maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
• Any clinically significant illness in the previous 28 days before day 1 of this study
• Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin and rifampin), in the previous 28 days before day 1 of this study
• Volunteers who took an Investigational Product (in another clinical trial) or donated 50 mL or more of blood in the previous 28 days before day 1 of this study
• Poor motivation, intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with the protocol requirements or inability to cooperate adequately, inability to understand and to observe the instructions of the physician
• Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study
• Positive urine screening of drugs of abuse
• Any history of tuberculosis and/or prophylaxis for tuberculosis
• Positive results to HIV, HBsAg or anti-HCV tests

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 A Fed/Fasted; A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on: Period 1: Fed Washout Period (7days) Period 2: Fasted	Drug: BIA 9-1067; A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days.; Other Names: Opicapone, OPC
Experimental: Group B Fasted/Fed; A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on: Period 1: Fasted Washout Period (7days) Period 2: Fed	Drug: BIA 9-1067; A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days.; Other Names: Opicapone, OPC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax - Maximum Observed Plasma Concentration	Cmax - Maximum observed plasma concentration of BIA 9-1067	Day 1
AUCt - Cumulative Area Under the Plasma Concentration Time Curve	AUCt - Cumulative Area Under the plasma concentration time Curve for BIA 9-1067	Day 1
Area Under the Concentration-time Curve Extrapolated to Infinity (AUC∞)	Area Under the Concentration-time Curve Extrapolated to Infinity (AUC∞) for BIA 9-1067	Day 1

Collaborators and Investigators

• Sponsor: Bial - Portela C S.A.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: January 19, 2012
• First Submitted That Met QC Criteria: February 24, 2014
• First Posted (Estimate): February 26, 2014

Study Record Updates

• Last Update Posted (Estimate): January 9, 2015
• Last Update Submitted That Met QC Criteria: December 31, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: BIA 9-1067; Opicapone,; Parkinson,; Bial,
• 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; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antiparkinson Agents; Anti-Dyskinesia Agents; Catechol O-Methyltransferase Inhibitors; Opicapone
• Other Study ID Numbers: BIA-91067-104