Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT01519284
First received: January 23, 2012
Last updated: July 22, 2015
Last verified: July 2015
  Purpose

To investigate the effect of repeated dosing of BIA 9-1067 on the levodopa pharmacokinetics, in comparison to placebo and entacapone.


Condition Intervention Phase
Parkinson Disease
Drug: BIA 9-1067 5 mg
Drug: Entacapone
Drug: Placebo
Drug: levodopa/carbidopa
Drug: BIA 9-1067 15 mg
Drug: BIA 9-1067 30 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomised, Placebo- and Active-controlled Multiple-dose Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetics Following a Levodopa/Carbidopa 100/25 mg Single-dose in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Bial - Portela C S.A.:

Primary Outcome Measures:
  • Cmax - Maximum Plasma Concentration of Levodopa [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
    Cmax - Maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days


Secondary Outcome Measures:
  • Tmax - Time to Reach Maximum Plasma Concentration of Levodopa [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
    Tmax - Time to Reach maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days.

  • AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification. [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
    AUC0-t - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to the last sampling time following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days

  • AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
    AUC0-∞ - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to infinity.


Enrollment: 82
Study Start Date: November 2009
Study Completion Date: June 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group 1
Placebo at all the dosing times
Drug: Placebo
placebo (four times a day)
Other Name: PLC, placebo
Experimental: Group 2

Day 1 to 7:

BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose

Day 8:

BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose

Drug: BIA 9-1067 5 mg
BIA 9-1067 OPC, Opicapone 5 mg
Other Name: OPC, Opicapone
Drug: Placebo
placebo (four times a day)
Other Name: PLC, placebo
Drug: levodopa/carbidopa
standard release levodopa/carbidopa 100/25 mg (single-dose)
Experimental: Group 3

Day 1 to 7:

BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose

Day 8:

BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose

Drug: Placebo
placebo (four times a day)
Other Name: PLC, placebo
Drug: levodopa/carbidopa
standard release levodopa/carbidopa 100/25 mg (single-dose)
Drug: BIA 9-1067 15 mg
BIA 9-1067 OPC, Opicapone 15 mg
Other Name: OPC, Opicapone
Experimental: Group 4

Day 1 to 7:

BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose

Day 8:

BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose

Drug: Placebo
placebo (four times a day)
Other Name: PLC, placebo
Drug: levodopa/carbidopa
standard release levodopa/carbidopa 100/25 mg (single-dose)
Drug: BIA 9-1067 30 mg
BIA 9-1067 OPC, Opicapone 30 mg
Other Name: OPC, Opicapone
Experimental: Group 5

Day 1 to 7:

Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose

Day 8:

Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose

Drug: Entacapone
Entacapone 200 mg
Drug: Placebo
placebo (four times a day)
Other Name: PLC, placebo
Drug: levodopa/carbidopa
standard release levodopa/carbidopa 100/25 mg (single-dose)

Detailed Description:

Single-centre, double-blind, randomised, parallel-group study in 80 young male and female healthy subjects.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 19 and 30 kg/m2, inclusive.
  • Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
  • Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening.
  • Clinical laboratory test results clinically acceptable at screening and admission to the treatment period.
  • Negative screen for alcohol and drugs of abuse at screening and admission to the treatment period.
  • 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: intrauterine device (by the subject) and condoms (by the partner) or diaphragm (by the subject) and condoms (by the partner) or spermicide (by the subject) and condoms (by the partner).
  • (If female) She had a negative urine pregnancy test at screening and admission to the treatment period.

Exclusion Criteria:

  • 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.
  • Clinically relevant surgical history.
  • Any abnormality in the coagulation tests.
  • Any abnormality in the liver function tests.
  • A history of relevant atopy or drug hypersensitivity.
  • A history or presence of narrow-angle glaucoma.
  • A suspicious undiagnosed skin lesions or a history of melanoma.
  • History of alcoholism or drug abuse.
  • Consumed more than 14 units of alcohol a week.
  • Significant infection or known inflammatory process at screening or admission to the treatment period.
  • Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to the treatment period.
  • Had used non-selective monoamine oxidase (MAO) inhibitors within 2 weeks of admission to the treatment period.
  • Had used medicines within 2 weeks of admission to the treatment period that may have affected the safety or other study assessments, in the investigator's opinion.
  • Had previously received BIA 9-1067.
  • Had used any investigational drug or participated in any clinical trial within 6 months prior to screening.
  • Had participated in more than 2 clinical trials within the 12 months prior to screening.
  • Had donated or received any blood or blood products within the 3 months prior to screening.
  • Vegetarians, vegans or had medical dietary restrictions.
  • Cannot communicate reliably with the investigator.
  • Unlikely to co-operate with the requirements of the study.
  • Unwilling or unable to gave written informed consent.
  • (If female) She was pregnant or breast-feeding.
  • (If female) She was of childbearing potential and she did not use an approved effective contraceptive method or she used oral contraceptives.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519284

Locations
Portugal
Bial - Portela & Cª, S.A.
S. Mamede do Coronado, Portugal, 4745-457
Sponsors and Collaborators
Bial - Portela C S.A.
Investigators
Principal Investigator: Manuel Vaz-da-Silva, MD, PhD BIAL - Portela & Cª S.A
  More Information

No publications provided

Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT01519284     History of Changes
Other Study ID Numbers: BIA-91067-114
Study First Received: January 23, 2012
Results First Received: July 22, 2015
Last Updated: July 22, 2015
Health Authority: Portugal: National Pharmacy and Medicines Institute

Keywords provided by Bial - Portela C S.A.:
Parkinson Disease
BIA 9-1067

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Carbidopa
Entacapone
Levodopa
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2015