Effect of Rasagiline on BIA 9-1067 Pharmacokinetics

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01532141
• Date of registration: 23/01/2012
• Prospective Registration: No
• Primary sponsor: Bial - Portela C S.A.
• Public title: Effect of Rasagiline on BIA 9-1067 Pharmacokinetics
• Scientific title: Effect of Rasagiline on BIA 9-1067 Pharmacokinetics in Healthy Subjects
• Date of first enrolment: November 2009
• Target sample size: 25
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01532141
• Study type: Interventional
• Phase: Phase 1

Countries of recruitment

France

Contacts

• Name: Béatrice Astruc, MD
• Affiliation: Biotrial - Human Pharmacology Unit

Key inclusion & exclusion 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 (ß-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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Rasagiline

Drug: BIA 9-1067

Primary Outcome(s)

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(s)

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]

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]

Secondary ID(s)

BIA-91067-113

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 20/08/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01532141