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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT02169427
• Date of registration: 24/01/2012
• Prospective Registration: No
• Primary sponsor: Bial - Portela C S.A.
• Public 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
• Scientific 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
• Date of first enrolment: March 2011
• Target sample size: 6
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02169427
• Study type: Interventional
• Phase: Phase 1

Countries of recruitment

Netherlands

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Parkinson's Disease (PD)

Intervention(s)

Drug: OPC

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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]

Secondary ID(s)

BIA-91067-122

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/08/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02169427