Comparative Bioavailability Study of BIA 9-1067 25 mg Capsules

• Sponsor: Bial - Portela C S.A. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02071823
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Duration (Months): 1
• Patients Per Site Per Month: 11.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson	Drug: BIA 9-1067	Phase 1

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Cmax - Maximum Observed Plasma Concentration [Day 1]

   Cmax - Maximum observed plasma concentration of BIA 9-1067

2. AUCt - Cumulative Area Under the Plasma Concentration Time Curve [Day 1]

   AUCt - Cumulative Area Under the plasma concentration time Curve for BIA 9-1067

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Algorithme Pharma Inc.	Mount-Royal	Quebec	Canada	H3P 3P1

Sponsors and Collaborators

• Bial - Portela C S.A.

Investigators

• Principal Investigator: Eric Sicard, MD, Algorithme Pharma Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bial - Portela C S.A.
• ClinicalTrials.gov Identifier: NCT02071823
• Other Study ID Numbers: BIA-91067-104
• First Posted: Feb 26, 2014
• Last Update Posted: Jan 9, 2015
• Last Verified: Dec 1, 2014

• Keywords provided by Bial - Portela C S.A.: Opicapone,; Parkinson,; Bial,; BIA 9-1067
• Additional relevant MeSH terms: Parkinson Disease; Opicapone

Study Results

Participant Flow

Arm/Group Title	Group A Fed/Fasted	Group B Fasted/Fed
Arm/Group Description	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 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.	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 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.
Period Title: Overall Study
STARTED	6	6
COMPLETED	5	6
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Group A Fed/Fasted	Group B Fasted/Fed	Total
Arm/Group Description	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 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.	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 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.	Total of all reporting groups
Overall Participants	6	6	12
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	6 100%	6 100%	12 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	6 100%	6 100%	12 100%

Outcome Measures

1. Primary Outcome

Title	Cmax - Maximum Observed Plasma Concentration
Description	Cmax - Maximum observed plasma concentration of BIA 9-1067
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fasted Conditions	Fed Condition
Arm/Group Description	Fasted conditions period	Fed condition period
Measure Participants	11	11
Mean (Standard Deviation) [ng/mL]	635.0 (250.8)	238.2 (168.4)

2. Primary Outcome

Title	AUCt - Cumulative Area Under the Plasma Concentration Time Curve
Description	AUCt - Cumulative Area Under the plasma concentration time Curve for BIA 9-1067
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fed Conditions	Fasted Condition
Arm/Group Description	Fed conditions period	Fasted condition period
Measure Participants	11	11
Mean (Standard Deviation) [ng·h/mL]	879.2 (286.6)	1989.5 (984.8)

3. Primary Outcome

Title	Area Under the Concentration-time Curve Extrapolated to Infinity (AUC∞)
Description	Area Under the Concentration-time Curve Extrapolated to Infinity (AUC∞) for BIA 9-1067
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fasted Conditions	Fed Condition
Arm/Group Description	Fasted conditions period	Fed condition period
Measure Participants	11	11
Mean (Standard Deviation) [ng·h/mL]	2113.6 (915.2)	1027.2 (545.4)

Adverse Events

Arm/Group Title	Fasted Conditions		Fed Condition
Arm/Group Description	Fasted conditions period		Fed condition period
All Cause Mortality
	Fasted Conditions		Fed Condition
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Fasted Conditions		Fed Condition
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Fasted Conditions		Fed Condition
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/11 (27.3%)		4/12 (33.3%)
Blood and lymphatic system disorders
Anaemia	0/11 (0%)		1/12 (8.3%)
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness	1/11 (9.1%)		0/12 (0%)
Nervous system disorders
Somnolence	2/11 (18.2%)		4/12 (33.3%)
Disturbance in attention	0/11 (0%)		1/12 (8.3%)
Headache	1/11 (9.1%)		0/12 (0%)
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis	0/11 (0%)		1/12 (8.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.