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

NCT02169427 | Completed Phase 1 Results

• 1 other identifier: BIA-91067-122
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease (PD)

Keywords

Parkinson's disease (PD); BIA 9-1067; Opicapone

Outcome Measures

Primary Outcomes (1)

• Cumulative Recovery of [14C]-Radioactivity

  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

  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

Secondary Outcomes (2)

• Cmax - Maximum Concentration

  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

• Tmax - Time to Attain Maximum Concentration

  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

Study Arms (1)

Opicapone (OPC)

EXPERIMENTAL

100 mg OPC

Drug: OPC

Interventions

OPC DRUG

The drug substance of 100 mg OPC was administered as 1 capsule.

Also known as: BIA 9-1067

Opicapone (OPC)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Gender: male
• Age: 18 - 55 years, inclusive
• Body Mass Index (BMI): 18.0 - 30.0 kg/m2, inclusive Body weight (kg)and height2 (m2)
• 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
• Medical history without major pathology
• Resting supine blood pressure and a resting pulse rate showing no clinically relevant deviations as judged by the MI
• Computerised (12-lead) electrocardiogram (ECG) recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the MI
• Willingness to use adequate contraception from the time of dosing until 3 months after the follow-up visit
• 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
• Willingness to sign the written ICF

You may not qualify if:

• Evidence of clinically relevant pathology
• Mental handicap
• History of relevant drug and/or food allergies
• Regular/routine treatment with non-topical medications within 30 days prior to entrance into the clinical research centre
• Smoking (less than 60 days prior to drug administration)
• History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
• 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
• 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
• 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
• Participation in another ADME study with a radiation burden -0.1 mSv in the period of 1 year before the start of the study
• 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
• Irregular defecation pattern (less than once per 2 days)
• Positive screen on drugs of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants and alcohol)
• 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)
• Positive screen on hepatitis B surface antigen (HBsAg)

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

PRA

Zuidlaren, 9471 GP, Netherlands

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

opicapone

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Head of Clinical Research
• Organization: Bial - Portela & Cª, S.A.

jose.rocha@bial.com

+351 229 866 100

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: June 23, 2014
• Study Start: March 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 21, 2015
• Results First Posted: August 21, 2015

Record last verified: 2015-07

Locations

NL (1)