Effect of BIA 9-1067 on Rasagiline Pharmacokinetics

NCT01532128 | Completed Phase 1 Results

• 1 other identifier: BIA-91067-112
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson Disease

Keywords

Parkinson Disease; BIA 9-1067

Outcome Measures

Primary Outcomes (1)

• Cmax - Maximum Observed Plasma Concentration

  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 Outcomes (2)

• Tmax - Time of Occurrence of Cmax

  pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose

• AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration

  pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose

Study Arms (3)

Group 1

EXPERIMENTAL

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; Drug: BIA 9-1067

Group 2

EXPERIMENTAL

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; Drug: BIA 9-1067

Group 3

EXPERIMENTAL

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; Drug: BIA 9-1067

Interventions

rasagiline DRUG

1 mg rasagiline (single-dose)

Group 1; Group 2; Group 3

BIA 9-1067 DRUG

50 mg BIA 9-1067 (single-dose)

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

BIOTRIAL

Rennes, F-35000, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

rasagiline; opicapone

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Head of Clinical Research
• Organization: Bial - Portela & Cª, S.A.

jose.rocha@bial.com

+351 229 866 100

Study Officials

• Béatric Astruc, MD

  Biotrial - Human Pharmacology Unit

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2012
• First Posted: February 14, 2012
• Study Start: November 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 20, 2015
• Results First Posted: August 20, 2015

Record last verified: 2015-07

Locations

FR (1)