Comparative Bioavailability Study of BIA 9-1067 25 mg Capsules

NCT02071823 | Completed Phase 1 Results

• 1 other identifier: BIA-91067-104
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson

Keywords

Opicapone,; Parkinson,; Bial,; BIA 9-1067

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Group A Fed/Fasted

EXPERIMENTAL

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

Group B Fasted/Fed

EXPERIMENTAL

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

Interventions

BIA 9-1067 DRUG

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.

Also known as: Opicapone, OPC

Group A Fed/Fasted; Group B Fasted/Fed

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

Algorithme Pharma Inc.

Mount Royal, Quebec, H3P 3P1, Canada

Location

MeSH Terms

Interventions

opicapone

Results Point of Contact

• Title: Head of Clinical Research
• Organization: Bial - Portela & Cª, S.A.

jose.rocha@bial.com

+351 229 866 100

Study Officials

• Eric Sicard, MD

  Algorithme Pharma Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2012
• First Posted: February 26, 2014
• Study Start: May 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: January 9, 2015
• Results First Posted: January 9, 2015

Record last verified: 2014-12

Locations

CA (1)