Effect of Rasagiline on BIA 9-1067 Pharmacokinetics

• ClinicalTrials.gov Identifier: NCT01532141
• Recruitment Status: Completed
• First Posted: February 14, 2012
• Results First Posted: August 20, 2015
• Last Update Posted: August 20, 2015
• Sponsor: Bial - Portela C S.A.
• Information provided by (Responsible Party): Bial - Portela C S.A.

Study Description

Brief Summary:

The purpose of this study is to investigate the effect of rasagiline on BIA 9-1067 pharmacokinetics in healthy subjects.

Condition or disease	Intervention/treatment	Phase
Parkinson Disease	Drug: BIA 9-1067; Drug: Rasagiline	Phase 1

Detailed Description:

Single-centre, open-label, randomised, three-way crossover study consisting of 3 single-dose periods separated by a washout of 14 days or more

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Rasagiline on BIA 9-1067 Pharmacokinetics in Healthy Subjects
• Study Start Date: November 2009
• Actual Primary Completion Date: February 2010
• Actual Study Completion Date: August 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group 1; Period 1: 50 mg BIA 9-1067 alone Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg	Drug: BIA 9-1067; 50 mg BIA 9-1067 (single-dose); Other Name: OPC, Opicapone; Drug: Rasagiline; 1 mg rasagiline (single-dose); Other Name: Azilect®
Experimental: Group 2; Period 1: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 alone Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg	Drug: BIA 9-1067; 50 mg BIA 9-1067 (single-dose); Other Name: OPC, Opicapone; Drug: Rasagiline; 1 mg rasagiline (single-dose); Other Name: Azilect®
Experimental: Group 3; Period 1: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone	Drug: BIA 9-1067; 50 mg BIA 9-1067 (single-dose); Other Name: OPC, Opicapone; Drug: Rasagiline; 1 mg rasagiline (single-dose); Other Name: Azilect®

Outcome Measures

Primary Outcome Measures :

1. Cmax - Maximum Observed Plasma Drug Concentration [ Time Frame: 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 :

1. Time of Occurrence of Cmax (Tmax) [ Time Frame: pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose ]
   6-mL blood samples for the determination of plasma concentrations of BIA 9-1067 and/or rasagiline will be drawn by direct venipuncture or via an intravenous catheter into potassium ethylenediaminetetraacetic acid(EDTA)Vacutainers
2. AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration [ Time Frame: pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose ]

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Subjects who were 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 18.0 and 30.0 kg/m2, inclusive.
• Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
• Subjects who had negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
• Subjects who had clinical laboratory test results clinically acceptable at screening and admission to each treatment period.
• Subjects who had a negative screen for alcohol and drugs of abuse at screening and admission to each treatment period.
• Subjects who were 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 pregnancy test (β-HCG) at screening and admission to each treatment period

Exclusion Criteria:

• Subjects who had a 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.
• Subjects who had a clinically relevant surgical history.
• Subjects who had any significant abnormality in the coagulation tests.
• Subjects who had any significant abnormality in the liver function tests (a case-by-case decision for any abnormality was to be discussed with the Sponsor before inclusion).
• Subjects who had a history of relevant atopy or drug hypersensitivity.
• Subjects who had a history of alcoholism or drug abuse.
• Subjects who consumed more than 14 units of alcohol a week.
• Subjects who had a significant infection or known inflammatory process at screening or admission to each treatment period.
• Subjects who had acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period.
• Subjects who had received fluoxetine within 5 weeks of admission to the first period.
• Subjects who had used any other medicines within 2 weeks of admission to first period that could affected the safety or other study assessments, in the investigator's opinion.
• Subjects who had previously received BIA 9-1067.
• Subjects who have used any investigational drug or participated in any clinical trial within 90 days prior to screening.
• Subjects who have donated or received any blood or blood products within the 3 months prior to screening.
• Subjects who were vegetarians, vegans or have medical dietary restrictions.
• Subjects who could not communicated reliably with the investigator.
• Subjects who were unlikely to co-operate with the requirements of the study.
• Subjects who were unwilling or unable to give written informed consent.
• (If female) She was pregnant or breast-feeding.
• (If female) She was of childbearing potential and she did not use an approved effective contraceptive method (double-barrier, intra-uterine device) or she uses oral contraceptives.

Contacts and Locations

Locations

France

BIOTRIAL

Rennes, France, F-35000

Sponsors and Collaborators

Bial - Portela C S.A.

Investigators

• Principal Investigator: Béatrice Astruc, MD; Biotrial - Human Pharmacology Unit

More Information

• Responsible Party: Bial - Portela C S.A.
• ClinicalTrials.gov Identifier: NCT01532141
• Other Study ID Numbers: BIA-91067-113
• First Posted: February 14, 2012
• Results First Posted: August 20, 2015
• Last Update Posted: August 20, 2015
• Last Verified: July 2015

Keywords provided by Bial - Portela C S.A.:

Parkinson Disease; BIA 9-1067

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Opicapone; Rasagiline; Monoamine Oxidase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Neuroprotective Agents; Protective Agents; Physiological Effects of Drugs; Catechol O-Methyltransferase Inhibitors; Antiparkinson Agents; Anti-Dyskinesia Agents