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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

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ClinicalTrials.gov Identifier: NCT02169466
Recruitment Status : Completed
First Posted : June 23, 2014
Results First Posted : November 3, 2015
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

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).

Condition or disease Intervention/treatment Phase
Parkinson's Disease (PD) Drug: BIA 9-1067 Drug: Placebo Drug: Madopar® HBS Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2009
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa

Arm Intervention/treatment
Experimental: Group 1

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.)

Drug: BIA 9-1067
OPC, Opicapone
Other Name: OPC, Opicapone

Drug: Placebo
PLC, Placebo
Other Name: PLC, Placebo

Drug: Madopar® HBS
controlled-release levodopa 100 mg/benserazide 25 mg

Experimental: Group 2

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.)

Drug: BIA 9-1067
OPC, Opicapone
Other Name: OPC, Opicapone

Drug: Placebo
PLC, Placebo
Other Name: PLC, Placebo

Drug: Madopar® HBS
controlled-release levodopa 100 mg/benserazide 25 mg

Experimental: Group 3

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.)

Drug: BIA 9-1067
OPC, Opicapone
Other Name: OPC, Opicapone

Drug: Placebo
PLC, Placebo
Other Name: PLC, Placebo

Drug: Madopar® HBS
controlled-release levodopa 100 mg/benserazide 25 mg

Experimental: Group 4

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.)

Drug: BIA 9-1067
OPC, Opicapone
Other Name: OPC, Opicapone

Drug: Placebo
PLC, Placebo
Other Name: PLC, Placebo

Drug: Madopar® HBS
controlled-release levodopa 100 mg/benserazide 25 mg




Primary Outcome Measures :
  1. Cmax - Maximum Observed Plasma Concentration of Levodopa [ Time Frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose. ]
    Primary pharmacokinetic parameter: Levodopa maximum observed plasma concentration (Cmax) (ng/mL)

  2. AUC0-t - Area Under the Plasma Concentration-time Curve [ Time Frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose. ]
    Primary pharmacokinetic parameter: Area under the plasma concentration-time curve for levodopa

  3. AUC0-∞ - AUC From Time Zero to Infinity [ Time Frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose. ]
    Primary pharmacokinetic parameter: Area under the plasma concentration-time curve from time zero to infinity for levodopa

  4. 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. ]
    Primary pharmacokinetic parameter: tmax - time to Cmax



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169466


Locations
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Portugal
BIAL - Portela & Cª - Human Pharmacology Unit (UFH)
S. Mamede do Coronado, Trofa, Portugal, 4745-457
Sponsors and Collaborators
Bial - Portela C S.A.
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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02169466    
Other Study ID Numbers: BIA-91067-109
First Posted: June 23, 2014    Key Record Dates
Results First Posted: November 3, 2015
Last Update Posted: November 3, 2015
Last Verified: October 2015
Keywords provided by Bial - Portela C S.A.:
Parkinson's disease (PD)
Opicapone
BIA 9-1067
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Opicapone
Benserazide, levodopa drug combination
Catechol O-Methyltransferase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs