Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 9-1067 and Metabolites

NCT01515891 | Completed Phase 1 Results

• 1 other identifier: BIA-91067-103
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the absorption, metabolism and excretion of BIA 9-1067.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; BIA 9-1067

Outcome Measures

Primary Outcomes (1)

• Maximum Plasma Concentration (Cmax)

  Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites

  24 hours:pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose

Secondary Outcomes (3)

• Time to Reach Maximum Plasma Concentration (Tmax)

  24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose

• Area Under the Plasma-concentration Time Curve Until the Last Quantifiable Sampling Point (AUC0-t)

  24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose

• Area Under the Plasma-concentration Time Curve With Extrapolation to Infinity (AUC0-∞)

  24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose

Study Arms (1)

BIA 9-1067

EXPERIMENTAL

90 µCi (3.33 MBq) \[14C\]-labeled of 100 mg BIA 9-1067 (single-dose).

Drug: BIA 9-1067

Interventions

BIA 9-1067 DRUG

90 µCi (3.33 MBq) \[14C\]-labeled of 100 mg BIA 9-1067 (single-dose).

Also known as: Opicapone

BIA 9-1067

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Caucasian male subjects, 40-55 years of age.
• Sitting blood pressure and pulse rate within a clinically acceptable range for the purposes of the study, i.e.: BP: 100 - 160 mmHg systolic, 50 - 95 mmHg diastolic and pulse rate: 50 - 100 bpm. Blood pressure and pulse were to be measured after 3 minutes resting in a sitting position.
• Subject body mass index was to be between 18 and 28 kg/m2
• Normal 12-lead ECG
• Ability to communicate well with the investigator and comply with the requirements of the entire study.
• The subject had given his written informed consent to participate in the study.

You may not qualify if:

• History of serious adverse reactions or hypersensitivity to any drug.
• Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
• History of alcohol or drug abuse in the last 5 years.
• Abnormal physical findings of clinical significance at the screening examination or baseline which would interfere with the objectives of the study.
• Need of any prescription medication within 14 days prior to the administration of the drug and/or nonprescription medication within 7 days prior to the administration of the drug.
• Participation in other clinical trials during the previous month in which an investigational drug or a commercially available drug was tested.
• Loss of 500 mL blood or more during the 3 month period before the study, e.g., as a donor.
• Existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the drug, i.e., impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhoea or conditions associated with total or partial obstruction of the urinary tract.
• Symptoms of a significant somatic or mental illness in the 4 week period preceding drug administration.
• History of hepatitis B and / or C and / or positive serology results which indicate the presence of hepatitis B and / or C.
• Positive results from the HIV serology.
• Clinically significant abnormal laboratory values (as determined by the Principal Investigator) at the screening evaluation, however, liver parameters (SGPT, SGOT) values must be within the normal range.
• Positive results of the drug screening.
• Known hypersensitivity to BIA 9-1067.
• Heavy smokers, i.e., more than 10 cigarettes per day

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

Covance Basel Research Unit AG (formerly Swiss Pharma Contract Ltd)

Allschwil, Base, CH-4123, Switzerland

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

Study Officials

• Seiberling Michael, MD

  Covance

  PRINCIPAL INVESTIGATOR

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 19, 2012
• First Posted: January 24, 2012
• Study Start: May 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: September 1, 2010
• Last Updated: January 9, 2015
• Results First Posted: January 9, 2015

Record last verified: 2014-12

Locations

CH (1)