NCT02763787

Brief Summary

The purpose of this study is to investigate the safety and tolerability of single oral rising doses of BIA 3-202 up to 800 mg (proposed doses 10 mg, 30 mg, 50 mg, 100 mg, 200 mg, 400 mg and 800 mg) in groups of 9 healthy male adult subjects, to characterise the preliminary pharmacokinetics of single rising oral doses of BIA 3-202 in healthy male adult subjects, to investigate the effects of single doses of BIA 3-202 on COMT activity in human erythrocytes and to investigate the effect of food on the pharmacokinetics of a single dose of BIA 3-202.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 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

April 1, 2000

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2000

Completed
15.9 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 16, 2016

Status Verified

May 1, 2016

Enrollment Period

2 months

First QC Date

May 4, 2016

Last Update Submit

May 13, 2016

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (4)

  • Maximum observed plasma concentration (Cmax)

    Pre dose, 15, 30, 60, 90, 120, 150, 180 minutes, 4, 6, 8, 12, 16, and 24 hours post dose.

  • Time of maximum observed concentration (tmax)

    Pre dose, 15, 30, 60, 90, 120, 150, 180 minutes, 4, 6, 8, 12, 16, and 24 hours post dose.

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

    Pre dose, 15, 30, 60, 90, 120, 150, 180 minutes, 4, 6, 8, 12, 16, and 24 hours post dose.

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

    Pre dose, 15, 30, 60, 90, 120, 150, 180 minutes, 4, 6, 8, 12, 16, and 24 hours post dose.

Study Arms (9)

Placebo

EXPERIMENTAL

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

Drug: Placebo

10 mg

EXPERIMENTAL

1 x 10 mg BIA 3-202 tablet BIA 3-202 was administered in the form of oral tablets, given with 200 ml potable water (single oral doses)

Drug: BIA 3-202

30 mg

EXPERIMENTAL

3 x 10 mg BIA 3-202 tablets BIA 3-202 was administered in the form of oral tablets, given with 200 ml potable water (single oral doses)

Drug: BIA 3-202

50 mg

EXPERIMENTAL

5 x 10 mg BIA 3-202 tablets BIA 3-202 was administered in the form of oral tablets, given with 200 ml potable water (single oral doses)

Drug: BIA 3-202

100 mg

EXPERIMENTAL

1 x 100 mg BIA 3-202 tablet BIA 3-202 was administered in the form of oral tablets, given with 200 ml potable water (single oral doses)

Drug: BIA 3-202

200 mg

EXPERIMENTAL

2 x 100 mg BIA 3-202 tablets

Drug: BIA 3-202

400 mg

EXPERIMENTAL

4 x 100 mg BIA 3-202 tablets BIA 3-202 was administered in the form of oral tablets, given with 200 ml potable water (single oral doses)

Drug: BIA 3-202

800 mg

EXPERIMENTAL

8 x 100 mg BIA 3-202 tablets BIA 3-202 was administered in the form of oral tablets, given with 200 ml potable water (single oral doses)

Drug: BIA 3-202

Food Effect (fed/fasted)

EXPERIMENTAL

400 mg BIA 3-202: 4 x 100 mg BIA 3-202 tablets BIA 3-202 was administered in the form of oral tablets, given with 200 ml potable water (single oral doses)

Drug: BIA 3-202

Interventions

BIA 3-202DRUG

single rising oral doses (10 mg, 30 mg, 50 mg, 100 mg, 200 mg, 400 mg, 800 mg)

Also known as: Nebicapone
10 mg100 mg200 mg30 mg400 mg50 mg800 mgFood Effect (fed/fasted)
PlaceboDRUG

Identical placebo

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 for at least 6 months preceding screening.
  • 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 (GDRU)

London, 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
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
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

April 1, 2000

Primary Completion

June 1, 2000

Study Completion

June 1, 2000

Last Updated

May 16, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)