Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide

Parkinson's Disease (PD) Clinical Trial

Official title:

Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide: a Double-blind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02169466
• Other study ID #: BIA-91067-109
• 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 & Cª, 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

• Parkinson Disease
• Parkinson's Disease (PD)

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