Comparative Bioavailability Study of BIA 9-1067 25 mg Capsules

Phase 1

Completed

Conditions: Parkinson

Interventions: Drug: BIA 9-1067

Registration Number: NCT02071823

Lead Sponsor: Bial - Portela C S.A.

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.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 12

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B Fasted/Fed	BIA 9-1067	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
Group A Fed/Fasted	BIA 9-1067	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

Primary Outcome Measures

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