NCT01519284

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P75+ for phase_1 parkinson-disease

Timeline
Completed

Started Nov 2009

Typical duration for phase_1 parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

August 20, 2015

Completed
Last Updated

August 20, 2015

Status Verified

July 1, 2015

Enrollment Period

3 months

First QC Date

January 23, 2012

Results QC Date

July 22, 2015

Last Update Submit

July 22, 2015

Conditions

Parkinson Disease

Keywords

Parkinson DiseaseBIA 9-1067

Outcome Measures

Primary Outcomes (1)

  • Cmax - Maximum Plasma Concentration of Levodopa

    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

    8 days

Secondary Outcomes (3)

  • Tmax - Time to Reach Maximum Plasma Concentration of Levodopa

    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.

    8 days

  • AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity

    8 days

Study Arms (5)

Group 1

PLACEBO COMPARATOR

Placebo at all the dosing times

Drug: Placebo

Group 2

EXPERIMENTAL

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 mgDrug: PlaceboDrug: levodopa/carbidopa

Group 3

EXPERIMENTAL

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: PlaceboDrug: levodopa/carbidopaDrug: BIA 9-1067 15 mg

Group 4

EXPERIMENTAL

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: PlaceboDrug: levodopa/carbidopaDrug: BIA 9-1067 30 mg

Group 5

EXPERIMENTAL

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: EntacaponeDrug: PlaceboDrug: levodopa/carbidopa

Interventions

BIA 9-1067 5 mgDRUG

BIA 9-1067 OPC, Opicapone 5 mg

Also known as: OPC, Opicapone
Group 2
EntacaponeDRUG

Entacapone 200 mg

Group 5
PlaceboDRUG

placebo (four times a day)

Also known as: PLC, placebo
Group 1Group 2Group 3Group 4Group 5
levodopa/carbidopaDRUG

standard release levodopa/carbidopa 100/25 mg (single-dose)

Group 2Group 3Group 4Group 5
BIA 9-1067 15 mgDRUG

BIA 9-1067 OPC, Opicapone 15 mg

Also known as: OPC, Opicapone
Group 3
BIA 9-1067 30 mgDRUG

BIA 9-1067 OPC, Opicapone 30 mg

Also known as: OPC, Opicapone
Group 4

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bial - Portela & Cª, S.A.

S. Mamede Do Coronado, 4745-457, Portugal

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

opicaponeentacaponecarbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Results Point of Contact

Title
Head of Clinical Research
Organization
Bial - Portela & Cª, S.A.
jose.rocha@bial.com
+351 229 866 100

Study Officials

  • Manuel Vaz-da-Silva, MD, PhD

    BIAL - Portela & Cª S.A

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2012

First Posted

January 26, 2012

Study Start

November 1, 2009

Primary Completion

February 1, 2010

Study Completion

June 1, 2011

Last Updated

August 20, 2015

Results First Posted

August 20, 2015

Record last verified: 2015-07

Locations

PT(1)