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An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and Metabolites

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02169427
Recruitment Status : Completed
First Posted : June 23, 2014
Results First Posted : August 21, 2015
Last Update Posted : August 21, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Brief Summary:
The purpose of this study is to determine the rate and routes of excretion of OPC and the mass balance in urine, faeces and expired air.

Condition or disease Intervention/treatment Phase
Parkinson's Disease (PD) Drug: OPC Phase 1

Detailed Description:

This was a single-centre, open-label ADME study in 6 healthy male subjects. Subjects received a single dose of 100 mg OPC, containing 3.39 MBq of [14C] OPC as oral capsules.

The study consisted of an eligibility screening period within 3 weeks prior to drug administration, admission on Day -1, a treatment period involving drug administration on Day 1 followed by matrix collections for PK purposes and safety evaluations up to Day 11, discharge on Day 11, six 24-hour hospitalizations on Days 14/15, 21/22 (+/ 1 day), 28/29 (+/- 1 day), 42/43 (+/- 2 days), 56/57 (+/- 2 days) and 77/78 (+/ 3 days) for PK sample collections, and a follow up visit performed at least 14 days after discharge from the last 24-hour hospitalization or at early discontinuation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and Metabolites Following a Single Dose Oral Administration
Study Start Date : March 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Opicapone (OPC)
100 mg OPC
Drug: OPC
The drug substance of 100 mg OPC was administered as 1 capsule.
Other Name: BIA 9-1067




Primary Outcome Measures :
  1. Cumulative Recovery of [14C]-Radioactivity [ Time Frame: pre-dose and 0-6, 6-12, 12-24, 24-48, 48 72, 72-96, 96 120, 120-144, 144-168, 168-192, 192-216 and 216-240 hours post-dose; 24-hour collections on Days 14/15, 21/22, 28/29 ]

    AEurine: Cumulative Recovery of [14C]-Radioactivity in urine AEfaeces: Cumulative Recovery of [14C]-Radioactivity in urine AEair: Cumulative Recovery of [14C]-Radioactivity in urine AEtotal: Cumulative Recovery of [14C]-Radioactivity in urine

    Recovery % of dose has been derived from area under the excretion rate (to infinity) from 240h onwards



Secondary Outcome Measures :
  1. Cmax - Maximum Concentration [ Time Frame: pre-dose and 0-6, 6-12, 12-24, 24-48, 48 72, 72-96, 96 120, 120-144, 144-168, 168-192, 192-216 and 216-240 hours post-dose; 24-hour collections on Days 14/15, 21/22, 28/29 ]
    BIA 9-1103 is a Opicapone (OPC, BIA 9-1067) metabolite

  2. Tmax - Time to Attain Maximum Concentration [ Time Frame: pre-dose and 0-6, 6-12, 12-24, 24-48, 48 72, 72-96, 96 120, 120-144, 144-168, 168-192, 192-216 and 216-240 hours post-dose; 24-hour collections on Days 14/15, 21/22, 28/29 ]
    BIA 9-1103 is a Opicapone (OPC, BIA 9-1067) metabolite



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Gender: male
  2. Age: 18 - 55 years, inclusive
  3. Body Mass Index (BMI): 18.0 - 30.0 kg/m2, inclusive Body weight (kg)and height2 (m2)
  4. Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "powerdrinks") and grapefruit (juice) from 48 hours prior to entry in the clinical research centre until discharge
  5. Medical history without major pathology
  6. Resting supine blood pressure and a resting pulse rate showing no clinically relevant deviations as judged by the MI
  7. Computerised (12-lead) electrocardiogram (ECG) recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the MI
  8. Willingness to use adequate contraception from the time of dosing until 3 months after the follow-up visit
  9. All values for haematology and for clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the MI
  10. Willingness to sign the written ICF

Exclusion Criteria:

  1. Evidence of clinically relevant pathology
  2. Mental handicap
  3. History of relevant drug and/or food allergies
  4. Regular/routine treatment with non-topical medications within 30 days prior to entrance into the clinical research centre
  5. Smoking (less than 60 days prior to drug administration)
  6. History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
  7. Use of concomitant medication, except for acetaminophen (paracetamol), which was allowed up to 3 days before entrance into the clinical research centre. Multivitamins and vitamin C were allowed up to 7 days before entrance into the clinical research centre. All other medication (including over the counter medication, health supplements, and herbal remedies such as St. John's wort extract) was to be stopped at least 14 days prior to entrance into the clinical research centre
  8. Participation in a drug study within 60 days prior to drug administration. Participation in more than 3 other drug studies in the 10 months preceding administration of study drug
  9. Donation of more than 50 mL of blood within 60 days prior to drug administration. Donation of more than 1.5 litres of blood in the 10 months preceding administration of study drug
  10. Participation in another ADME study with a radiation burden -0.1 mSv in the period of 1 year before the start of the study
  11. Exposure to radiation for diagnostic reasons (except dental X-rays and plain X rays of thorax and bony skeleton - excluding spinal column), during work or during participation in a medical study in the previous year
  12. Irregular defecation pattern (less than once per 2 days)
  13. Positive screen on drugs of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants and alcohol)
  14. Intake of more than 24 units of alcohol per week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)
  15. Positive screen on hepatitis B surface antigen (HBsAg)
  16. Positive screen on anti-hepatitis C virus (HCV)
  17. Positive screen on anti- human immunodeficiency virus (HIV) 1/2
  18. Illness within 5 days prior to drug administration

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): NCT02169427


Locations
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Netherlands
PRA
Zuidlaren, Netherlands, 9471 GP
Sponsors and Collaborators
Bial - Portela C S.A.

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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02169427    
Other Study ID Numbers: BIA-91067-122
First Posted: June 23, 2014    Key Record Dates
Results First Posted: August 21, 2015
Last Update Posted: August 21, 2015
Last Verified: July 2015
Keywords provided by Bial - Portela C S.A.:
Parkinson's disease (PD)
BIA 9-1067
Opicapone
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
Opicapone
Catechol O-Methyltransferase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiparkinson Agents
Anti-Dyskinesia Agents