NCT02774564

Brief Summary

The purpose of this study is to the effect of three single oral doses of nebicapone (50 mg, 100 mg and 200 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of controlled release levodopa 200 mg/carbidopa 50 mg (Sinemet CR 200/50).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_1

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

September 1, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
10.5 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
Last Updated

May 19, 2016

Status Verified

May 1, 2016

Enrollment Period

2 months

First QC Date

May 13, 2016

Last Update Submit

May 18, 2016

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (4)

  • Cmax

    Cmax - Maximum observed plasma concentration of levodopa following oral administration of single-doses of Sinemet® CR 200/50 concomitantly with placebo or nebicapone

    pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.

  • Tmax

    Tmax - Time to occurrence of Cmax of levodopa following oral administration of single-doses of Sinemet® CR 200/50 concomitantly with placebo or nebicapone

    pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.

  • AUC0-t

    AUC0-t - Area under the plasma concentration-time curve from time 0 to the last sampling time at which concentration were at or above the Limit of quantification of levodopa following oral administration of single-doses of Sinemet® CR 200/50 concomitantly with placebo or nebicapone

    pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.

  • AUC0-∞

    AUC0-∞ - Area under the plasma concentration-time curve extrapolated to infinity of levodopa following oral administration of single-doses of Sinemet® CR 200/50 concomitantly with placebo or nebicapone

    pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.

Study Arms (4)

Nebicapone 50 mg

EXPERIMENTAL

1 tablet of 50 mg plus 3 tablets of placebo concomitantly with 1 tablet of Sinemet® CR 200/50 (levodopa 200 mg / carbidopa 50 mg)

Drug: BIA 3-202Drug: PlaceboDrug: Sinemet®

Nebicapone 100 mg

EXPERIMENTAL

2 tablets of 50 mg plus 2 tablets of placebo concomitantly with 1 tablet of Sinemet® CR 200/50 (levodopa 200 mg / carbidopa 50 mg)

Drug: BIA 3-202Drug: PlaceboDrug: Sinemet®

Nebicapone 200 mg

EXPERIMENTAL

4 tablets of 50 mg concomitantly with 1 tablet of Sinemet® CR 200/50 (levodopa 200 mg / carbidopa 50 mg)

Drug: BIA 3-202Drug: Sinemet®

Placebo

PLACEBO COMPARATOR

4 tablets concomitantly with 1 tablet of Sinemet® CR 200/50 (levodopa 200 mg / carbidopa 50 mg)

Drug: PlaceboDrug: Sinemet®

Interventions

BIA 3-202DRUG

Nebicapone tablets 50 mg, oral administration

Also known as: Nebicapone
Nebicapone 100 mgNebicapone 200 mgNebicapone 50 mg
PlaceboDRUG

Nebicapone matching placebo tablets

Nebicapone 100 mgNebicapone 50 mgPlacebo
Sinemet®DRUG

Sinemet® CR 200/50 (levodopa 200 mg / carbidopa 50 mg) tablets

Nebicapone 100 mgNebicapone 200 mgNebicapone 50 mgPlacebo

Eligibility Criteria

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

You may qualify if:

  • Male or female subjects aged 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 clinically acceptable at screening and admission to first treatment period.
  • Subjects who had negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening.
  • Subjects who had a negative screen for alcohol and 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.
  • (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: double barrier, intrauterine device or abstinence.
  • (If female) She had a negative urine pregnancy test at screening and admission to each treatment period.

You may not qualify if:

  • 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 had 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 had used any investigational drug or participated in any clinical trial within 2 months of their first admission.
  • Subjects who had 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Pharmacology Unit

S. Mamede Do Coronado, S. Mamede Do Coronado, 4745-457, Portugal

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

nebicaponecarbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

May 13, 2016

First Posted

May 17, 2016

Study Start

September 1, 2005

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

May 19, 2016

Record last verified: 2016-05

Locations

PT(1)