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

Primary Purpose

Parkinson's Disease (PD)

Status

Completed

Phase

Phase 1

Locations

Portugal

Study Type

Interventional

Intervention

BIA 9-1067

Placebo

Madopar® HBS

About this trial

This is an interventional treatment trial for Parkinson's Disease (PD) focused on measuring Parkinson's disease (PD), Opicapone, BIA 9-1067

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

BIAL - Portela & Cª - Human Pharmacology Unit (UFH)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)

Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)

Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)

Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)

Outcomes

Primary Outcome Measures

Cmax - Maximum Observed Plasma Concentration of Levodopa

Primary pharmacokinetic parameter: Levodopa maximum observed plasma concentration (Cmax) (ng/mL)

AUC0-t - Area Under the Plasma Concentration-time Curve

Primary pharmacokinetic parameter: Area under the plasma concentration-time curve for levodopa

AUC0-∞ - AUC From Time Zero to Infinity

Primary pharmacokinetic parameter: Area under the plasma concentration-time curve from time zero to infinity for levodopa

Tmax - Time to Cmax

Primary pharmacokinetic parameter: tmax - time to Cmax

Secondary Outcome Measures

Full Information

NCT ID

NCT02169466

First Posted

January 20, 2012

Last Updated

October 2, 2015

Sponsor

Bial - Portela C S.A.

1. Study Identification

Unique Protocol Identification Number

NCT02169466

Brief 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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bial - Portela C S.A.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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).

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease (PD)

Keywords

Parkinson's disease (PD), Opicapone, BIA 9-1067

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Arm Title

Group 3

Arm Type

Experimental

Arm Description

Arm Title

Group 4

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

BIA 9-1067

Other Intervention Name(s)

OPC, Opicapone

Intervention Description

OPC, Opicapone

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

PLC, Placebo

Intervention Description

PLC, Placebo

Intervention Type

Drug

Intervention Name(s)

Madopar® HBS

Intervention Description

controlled-release levodopa 100 mg/benserazide 25 mg

Primary Outcome Measure Information:

Title

Cmax - Maximum Observed Plasma Concentration of Levodopa

Description

Primary pharmacokinetic parameter: Levodopa maximum observed plasma concentration (Cmax) (ng/mL)

Time Frame

pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.

Title

AUC0-t - Area Under the Plasma Concentration-time Curve

Description

Primary pharmacokinetic parameter: Area under the plasma concentration-time curve for levodopa

Time Frame

pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.

Title

AUC0-∞ - AUC From Time Zero to Infinity

Description

Primary pharmacokinetic parameter: Area under the plasma concentration-time curve from time zero to infinity for levodopa

Time Frame

pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.

Title

Tmax - Time to Cmax

Description

Primary pharmacokinetic parameter: tmax - time to Cmax

Time Frame

pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

BIAL - Portela & Cª - Human Pharmacology Unit (UFH)

City

S. Mamede do Coronado

State/Province

Trofa

ZIP/Postal Code

4745-457

Country

Portugal

12. IPD Sharing Statement

Learn more about this trial

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

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