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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02169466
Other study ID # BIA-91067-109
Secondary ID
Status Completed
Phase Phase 1
First received January 20, 2012
Last updated October 2, 2015
Start date January 2009
Est. completion date May 2009

Study information

Verified date October 2015
Source Bial - Portela C S.A.
Contact n/a
Is FDA regulated No
Health authority Portugal: INFARMED, National Authority of Medicines and Health Products, IP
Study type Interventional

Clinical Trial Summary

To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of controlled-release levodopa 100 mg/benserazide 25 mg (Madopar HBS).


Description:

Single centre, double-blind, randomized, placebo-controlled, crossover study with four consecutive single-dose treatment periods. The washout period between doses was to be at least10 days. On each treatment period (25, 50 and 100 mg BIA 9-1067 or placebo), after completion of pre-dose assessments, BIA 9-1067-Placebo was to be administered concomitantly with the dose of Madopar HBS; post-dose assessments were to be completed and subjects were to be discharged 72 h post-dose.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Male subjects between 18 and 45 years, inclusive.

- Subjects of body mass index (BMI) between 19 and 30 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 clinical laboratory test results that were clinically acceptable at screening and admission to first treatment period.

- Subjects who had negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibodies (HCV Ab), and Human immunodeficiency viruses -1 and -2 antibodies (HIV-1 and HIV-2 Ab) at screening.

- Subjects who had/were negative for drugs of abuse at screening and admission to each treatment period.

- Subjects who were non-smokers or who smoked =10 cigarettes or equivalent per day.

- Subjects who were able and willing to give written informed consent.

Exclusion Criteria:

- Subjects who did not conform to the above inclusion criteria, or

- 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 a clinically relevant family history.

- Subjects who had a history of relevant atopy.

- Subjects who had a history of relevant drug hypersensitivity.

- Subjects who had a history of glaucoma.

- Subjects who had a history of alcoholism or drug abuse.

- Subjects who consumed more than 21 units of alcohol a week.

- Subjects who had a significant infection or known inflammatory process on screening or first admission.

- Subjects who had acute gastrointestinal symptoms at the time of screening or first admission (e.g., nausea, vomiting, diarrhoea, heartburn).

- Subjects who used medicines within 2 weeks of first admission that, in the opinion of the investigator, may affect the safety or other study assessments.

- Subjects who used any investigational drug or participated in any clinical trial within 2 months of their first admission.

- Subjects who donated or received any blood or blood products within the previous 2 months prior to screening.

- Subjects who were vegetarians, vegans or have medical dietary restrictions.

- Subjects who could not communicate 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.

- Subjects who were BIAL - Portela & CÂȘ, SA employees.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
BIA 9-1067
OPC, Opicapone
Placebo
PLC, Placebo
Madopar® HBS
controlled-release levodopa 100 mg/benserazide 25 mg

Locations

Country Name City State
Portugal BIAL - Portela & Cª - Human Pharmacology Unit (UFH) S. Mamede do Coronado Trofa

Sponsors (1)

Lead Sponsor Collaborator
Bial - Portela C S.A.

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cmax - Maximum Observed Plasma Concentration of Levodopa Primary pharmacokinetic parameter: Levodopa maximum observed plasma concentration (Cmax) (ng/mL) pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose. No
Primary AUC0-t - Area Under the Plasma Concentration-time Curve Primary pharmacokinetic parameter: Area under the plasma concentration-time curve for levodopa pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose. No
Primary AUC0-8 - AUC From Time Zero to Infinity Primary pharmacokinetic parameter: Area under the plasma concentration-time curve from time zero to infinity for levodopa pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose. No
Primary Tmax - Time to Cmax Primary pharmacokinetic parameter: tmax - time to Cmax pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose. No
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