Effect of BIA 9-1067 on Rasagiline Pharmacokinetics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT01532128
First received: January 23, 2012
Last updated: June 20, 2012
Last verified: June 2012

January 23, 2012
June 20, 2012
November 2009
February 2010   (final data collection date for primary outcome measure)
maximum observed plasma concentration (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 ] [ Designated as safety issue: No ]
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
blood samples for the determination of plasma concentrations of rasagiline and/or BIA 9-1067 [ Time Frame: 45 days ] [ Designated as safety issue: Yes ]
Pharmacokinetics
Complete list of historical versions of study NCT01532128 on ClinicalTrials.gov Archive Site
  • Number of participants with Adverse Events [ Time Frame: 45 days ] [ Designated as safety issue: Yes ]
    assess tolerability of combined use of BIA 9-1067 and rasagiline in healthy subjects
  • 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 ] [ Designated as safety issue: No ]
    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
  • Area under the plasma concentration-time curve (AUC) [ 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 ] [ Designated as safety issue: No ]
    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
  • the apparent terminal half-life (t½) [ 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 ] [ Designated as safety issue: No ]
    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
  • apparent total body clearance (CL/F) [ 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 ] [ Designated as safety issue: No ]
    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
  • apparent volume of distribution (V/F) [ 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 ] [ Designated as safety issue: No ]
    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
Recorded adverse events, clinical laboratory safety tests, vital signs [ Time Frame: 45 days ] [ Designated as safety issue: Yes ]
assess tolerability of combined use of BIA 9-1067 and rasagiline in healthy subjects
Not Provided
Not Provided
 
Effect of BIA 9-1067 on Rasagiline Pharmacokinetics
Effect of BIA 9-1067 on Rasagiline Pharmacokinetics in Healthy Subjects

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

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Parkinson Disease
  • Drug: rasagiline
    1 mg rasagiline (single-dose)
  • Drug: BIA 9-1067
    50 mg BIA 9-1067 (single-dose)
  • Experimental: BIA 9-1067
    Intervention: Drug: BIA 9-1067
  • Active Comparator: rasagiline
    Intervention: Drug: rasagiline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
July 2010
February 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01532128
BIA-91067-112
No
Bial - Portela C S.A.
Bial - Portela C S.A.
Not Provided
Principal Investigator: Béatric Astruc, MD Biotrial - Human Pharmacology Unit
Bial - Portela C S.A.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP