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Study to Investigate the Tolerability, Steady-state Pharmacokinetics and Erythrocyte COMT Inhibition of BIA 3-202

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ClinicalTrials.gov Identifier: NCT02772627
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Brief Summary:
The purpose of this study is to investigate the tolerability and safety of three multiple dose regimens of nebicapone (BIA 3-202 100 mg, 200 mg, and 300 mg 6 times daily) in healthy volunteers. To characterise the steady-state pharmacokinetic and erythrocyte COMT inhibition profiles of nebicapone in healthy volunteers.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Nebicapone Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study to Investigate the Tolerability, Steady-state Pharmacokinetics and Erythrocyte COMT Inhibition of BIA 3-202 in Healthy Volunteers.
Study Start Date : September 2001
Actual Primary Completion Date : December 2001
Actual Study Completion Date : December 2001

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Arm Intervention/treatment
Experimental: Nebicapone 100 mg / Placebo
Treatment consisted of nebicapone/placebo repeated administration: one dose at 4-h intervals, for 7 full days: first dose at approximately 08 h (±1 h) on Day 1 and final dose at approximately 08 h (±1 h) on Day 8. Within each group (n=8), 2 volunteers were be randomised to receive placebo and the remaining 6 volunteers to receive nebicapone.
Drug: Nebicapone
Nebicapone 100 mg tablets; oral route.
Other Name: BIA 3-202

Drug: Placebo
Placebo tablets; oral route.

Experimental: Nebicapone 200 mg / Placebo
Treatment consisted of nebicapone/placebo repeated administration: one dose at 4-h intervals, for 7 full days: first dose at approximately 08 h (±1 h) on Day 1 and final dose at approximately 08 h (±1 h) on Day 8. Within each group (n=8), 2 volunteers were be randomised to receive placebo and the remaining 6 volunteers to receive nebicapone.
Drug: Nebicapone
Nebicapone 100 mg tablets; oral route.
Other Name: BIA 3-202

Drug: Placebo
Placebo tablets; oral route.

Experimental: Nebicapone 300 mg / Placebo
Treatment consisted of nebicapone/placebo repeated administration: one dose at 4-h intervals, for 7 full days: first dose at approximately 08 h (±1 h) on Day 1 and final dose at approximately 08 h (±1 h) on Day 8. Within each group (n=8), 2 volunteers were be randomised to receive placebo and the remaining 6 volunteers to receive nebicapone.
Drug: Nebicapone
Nebicapone 100 mg tablets; oral route.
Other Name: BIA 3-202

Drug: Placebo
Placebo tablets; oral route.




Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) - Nebicapone [ Time Frame: Day 8 ]
    Mean nebicapone plasma concentration-time profiles following the last dose (Day 8) of a multiple-dose oral administration of nebicapone (100 mg, 200 mg or 300 mg, at 4-h intervals)

  2. Time of maximum observed concentration (tmax) - Nebicapone [ Time Frame: Day 8 ]
    Mean nebicapone plasma concentration-time profiles following the last dose (Day 8) of a multiple-dose oral administration of nebicapone (100 mg, 200 mg or 300 mg, at 4-h intervals)

  3. Area under the plasma concentration time curve extrapolated to infinity (AUC0-∞) - Nebicapone [ Time Frame: Day 8 ]
    Mean nebicapone plasma concentration-time profiles following the last dose (Day 8) of a multiple-dose oral administration of nebicapone (100 mg, 200 mg or 300 mg, at 4-h intervals)

  4. Apparent terminal elimination half-life (t1/2) - Nebicapone [ Time Frame: Day 8 ]
    Mean nebicapone plasma concentration-time profiles following the last dose (Day 8) of a multiple-dose oral administration of nebicapone (100 mg, 200 mg or 300 mg, at 4-h intervals)

  5. Maximum observed plasma concentration (Cmax) - 3-O-methylnebicapone (BIA 3-270) [ Time Frame: Day 8 ]
    Mean 3-O-methylnebicapone (BIA 3-270) plasma concentration-time profiles following the last dose (Day 8) of a multiple-dose oral administration of nebicapone (100 mg, 200 mg or 300 mg, at 4-h intervals)

  6. Time of maximum observed concentration (tmax) - 3-O-methylnebicapone (BIA 3-270) [ Time Frame: Day 8 ]
    Mean 3-O-methylnebicapone (BIA 3-270) plasma concentration-time profiles following the last dose (Day 8) of a multiple-dose oral administration of nebicapone (100 mg, 200 mg or 300 mg, at 4-h intervals)

  7. Area under the plasma concentration time curve extrapolated to infinity (AUC0-∞) - 3-O-methylnebicapone (BIA 3-270) [ Time Frame: Day 8 ]
    Mean 3-O-methylnebicapone (BIA 3-270) plasma concentration-time profiles following the last dose (Day 8) of a multiple-dose oral administration of nebicapone (100 mg, 200 mg or 300 mg, at 4-h intervals)

  8. Apparent terminal elimination half-life (t1/2) - 3-O-methylnebicapone (BIA 3-270) [ Time Frame: Day 8 ]
    Mean 3-O-methylnebicapone (BIA 3-270) plasma concentration-time profiles following the last dose (Day 8) of a multiple-dose oral administration of nebicapone (100 mg, 200 mg or 300 mg, at 4-h intervals)



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female subjects aged between 18 and 45 years, inclusive.
  • Subjects of body mass index (BMI) between 19 and 28 kg/m2, inclusive.
  • 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 Ab and HIV-1 and HIV-2 Ab tests at screening.
  • Subjects who were negative for drugs of abuse and alcohol at screening and admission.
  • Subjects who were non-smokers or who smoke less than 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.

Exclusion Criteria:

  • Subjects who did not conform to the above inclusion criteria, or
  • 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 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 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 oral contraceptives or over the counter medication excluding oral 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.
  • Subjects who had donated and/or received any blood or blood products within the previous 2 months prior to screening.
  • Subjects who were vegetarians, vegans and/or have medical dietary restrictions.
  • Subjects who could not communicate reliably with the investigator.
  • Subjects who were unlikely to co-operate with the requirements of the study.
  • (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.
  • Subjects who were unwilling or unable to give written informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772627


Locations
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Portugal
Human Pharmacology Unit - BIAL - Portela & Ca, S.A.
S. Mamede do Coronado, Portugal, 4745-457
Sponsors and Collaborators
Bial - Portela C S.A.
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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02772627    
Other Study ID Numbers: BIA-3202-105
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Bial - Portela C S.A.:
Parkinson's disease, Nebicapone
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases