NCT02763800

Brief Summary

The objectives as stated in the study protocol were as follows:

  • To investigate the safety and tolerability of three multiple dose regimens of BIA 3-202 (50 mg twice a day, 100 mg twice a day and 200 mg twice a day in healthy young male volunteers). Part A
  • To characterise the steady state pharmacokinetic and pharmacodynamic profile of BIA 3-202 in healthy young males. Part A
  • To investigate the safety and tolerability of a single multiple dose regimen (dose to be determined from Part A) of BIA 3-202, in healthy elderly volunteers. Part B
  • To characterise the steady state pharmacokinetic and pharmacodynamic profile of a single multiple dose regimen (dose to be determined from Part A) of BIA 3- 202 in healthy elderly volunteers. Part B

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2000

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, 2000

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2001

Completed
15.3 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
Last Updated

May 5, 2016

Status Verified

May 1, 2016

Enrollment Period

4 months

First QC Date

May 4, 2016

Last Update Submit

May 4, 2016

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseNebicapone

Outcome Measures

Primary Outcomes (8)

  • Maximum observed plasma concentration (Cmax) - D1

    Day 1

  • Time of maximum observed concentration (tmax) - D1

    Day 1

  • Area under the plasma concentration time curve to last measurable time point (AUC0-t) - D1

    Day 1

  • Area under the plasma concentration time curve extrapolated to infinity (AUC0-∞) - D1

    Day 1

  • Maximum observed plasma concentration (Cmax) - D9

    Day 9

  • Time of maximum observed concentration (tmax) - D9

    Day 9

  • Area under the plasma concentration time curve to last measurable time point (AUC0-t) - D9

    Day 9

  • Area under the plasma concentration time curve extrapolated to infinity (AUC0-∞) - D9

    Day 9

Study Arms (4)

Group 1: BIA 3-202 50 mg/placebo

EXPERIMENTAL

Group 1: BIA 3-202 50 mg/placebo on Day 1; BIA 3-202 50 mg/placebo b.i.d. on Days 3-8 inclusively; final single dose of BIA 3-202 50 mg/placebo on Day 9. 50 mg BIA 3-202: 5 x 10 mg BIA 3-202 tablets

Drug: BIA 3-202Drug: Placebo

Group 2: BIA 3-202 100 mg/placebo

EXPERIMENTAL

Group 2: BIA 3-202 100 mg/placebo on Day 1; BIA 3-202 100 mg/placebo b.i.d. on Days 3-8 inclusively; final single dose of BIA 3-202 100 mg/placebo on Day 9. 100 mg BIA 3-202: 1 x 100 mg BIA 3-202 tablet

Drug: BIA 3-202Drug: Placebo

Group 3: BIA 3-202 200 mg/placebo

EXPERIMENTAL

Group 3: BIA 3-202 200 mg/placebo on Day 1; BIA 3-202 200 mg/placebo b.i.d. on Days 3-8 inclusively; final single dose of BIA 3-202 200 mg/placebo on Day 9. 200 mg BIA 3-202: 2 x 100 mg BIA 3-202 tablets

Drug: BIA 3-202Drug: Placebo

Group 4: BIA 3-202 200 mg/placebo

EXPERIMENTAL

Group 4: BIA 3-202 200 mg/placebo on Day 1; BIA 3-202 200 mg/placebo t.i.d. on Days 3-8 inclusively; final single dose of BIA 3-202 200 mg/placebo on Day 9. 200 mg BIA 3-202: 2 x 100 mg BIA 3-202 tablets

Drug: BIA 3-202Drug: Placebo

Interventions

BIA 3-202DRUG

BIA 3-202 (50, 100 and 200 mg) was administered in the form of oral tablets, given with 200 ml potable water.

Group 1: BIA 3-202 50 mg/placeboGroup 2: BIA 3-202 100 mg/placeboGroup 3: BIA 3-202 200 mg/placeboGroup 4: BIA 3-202 200 mg/placebo
PlaceboDRUG

Matched placebo was administered in the form of oral tablets, given with 200 ml potable water

Group 1: BIA 3-202 50 mg/placeboGroup 2: BIA 3-202 100 mg/placeboGroup 3: BIA 3-202 200 mg/placeboGroup 4: BIA 3-202 200 mg/placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult males aged 18-35 years, with a body mass index (BMI) of 19-28 kg/m2.
  • Subjects who were healthy as determined by pre-study medical history, physical examination and 12-lead ECG.
  • Subjects who had clinical laboratory tests acceptable to the investigator.
  • Subjects who were negative for HbsAg, anti-HCV and HIV I and II tests at screening.
  • Subjects who were negative for drugs of abuse and alcohol tests at screening and admission.
  • Subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per day.
  • Subjects who were able and willing to give written informed consent.

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, 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 alcoholism.
  • Subjects who had a history of drug abuse.
  • Subjects who consumed more than 28 units of alcohol a week.
  • Subjects who had a significant infection or known inflammatory process on screening and/or admission.
  • Subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhoea, heartburn).
  • Subjects who had an acute infection such as influenza at the time of screening and/or admission.
  • Subjects who had used prescription drugs within 4 weeks of first dosing.
  • Subjects who had used over the counter medication, excluding routine vitamins but including mega dose vitamin therapy, within one week of first dosing.
  • Subjects who had used any investigational drug and/or participated in any clinical trial within 3 months of their first admission to this study.
  • Subjects who had previously received BIA 3-202.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's Drug Research Unit

London, SE1 1YR, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

nebicapone

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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2016

First Posted

May 5, 2016

Study Start

September 1, 2000

Primary Completion

January 1, 2001

Study Completion

January 1, 2001

Last Updated

May 5, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)