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Effect of BIA 9-1067 on Rasagiline Pharmacokinetics

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ClinicalTrials.gov Identifier: NCT01532128
Recruitment Status : Completed
First Posted : February 14, 2012
Results First Posted : August 20, 2015
Last Update Posted : August 20, 2015
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: rasagiline Drug: BIA 9-1067 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 : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of BIA 9-1067 on Rasagiline Pharmacokinetics in Healthy Subjects
Study Start Date : November 2009
Primary Completion Date : February 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Group 1
Period 1: rasagiline 1 mg Period 2: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 3: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg
Drug: rasagiline
1 mg rasagiline (single-dose)
Drug: BIA 9-1067
50 mg BIA 9-1067 (single-dose)
Experimental: Group 2
Period 1: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 2: rasagiline 1 mg Period 3: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg
Drug: rasagiline
1 mg rasagiline (single-dose)
Drug: BIA 9-1067
50 mg BIA 9-1067 (single-dose)
Experimental: Group 3
Period 1: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 2: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 3: rasagiline 1 mg
Drug: rasagiline
1 mg rasagiline (single-dose)
Drug: BIA 9-1067
50 mg BIA 9-1067 (single-dose)


Outcome Measures

Primary Outcome Measures :
  1. Cmax - Maximum Observed Plasma 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. Tmax - Time of Occurrence of Cmax [ 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 ]
  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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01532128


Locations
France
BIOTRIAL
Rennes, France, F-35000
Sponsors and Collaborators
Bial - Portela C S.A.
Investigators
Principal Investigator: Béatric Astruc, MD Biotrial - Human Pharmacology Unit
More Information

Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT01532128     History of Changes
Other Study ID Numbers: BIA-91067-112
First Posted: February 14, 2012    Key Record Dates
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
Neurodegenerative Diseases
Rasagiline
Opicapone
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