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

Parkinson Disease Clinical Trial

Official title:

An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 9-1067 and Metabolites Following a Single-dose Oral Administration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01515891
• Other study ID #: BIA-91067-103
• Status: Completed
• Phase: Phase 1
• First received: January 19, 2012
• Last updated: December 30, 2014
• Start date: May 2009
• Est. completion date: September 2010

Study information

• Verified date: December 2014
• Source: Bial - Portela C S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

Description:

Monocentre, open, non-placebo-controlled, single-group, single-dose study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: September 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• Exposure to artificial ionizing radiation in the last 12 months (e.g., x-ray investigation)

• Subject who had more than 4 flights (with more than 2 hours flight time) within the last year prior to the administration of the drug.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Switzerland	Covance Basel Research Unit AG (formerly Swiss Pharma Contract Ltd)	Allschwil	Base

Sponsors (1)

Lead Sponsor	Collaborator
Bial - Portela C S.A.

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time to Reach Maximum Plasma Concentration (Tmax)	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 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	No
Secondary	Area Under the Plasma-concentration Time Curve Until the Last Quantifiable Sampling Point (AUC0-t)	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 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	No
Secondary	Area Under the Plasma-concentration Time Curve With Extrapolation to Infinity (AUC0-8)	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 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	No