Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-BIA 9-1067

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03119194
• Date of registration: 13/04/2017
• Prospective Registration: No
• Primary sponsor: Bial - Portela C S.A.
• Public title: Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-BIA 9-1067
• Scientific title: An Open-Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-BIA 9-1067 in Healthy Male Subjects
• Date of first enrolment: January 27, 2017
• Target sample size: 7
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03119194
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United Kingdom

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy males;

- Age 30 to 65 years of age;

- Body mass index of 18.0 to 35.0 kg/m2 or, if outside the range, considered not
clinically significant by the investigator;

- Normal resting supine blood pressure and pulse or showing no clinically relevant
deviation as judged by the investigator;

- Computerized (12-lead) ECG recording without signs of clinically relevant pathology or
showing no clinically relevant deviations as judged by the investigator;

- All values for clinical laboratory tests of blood and urine within the normal range or
showing no clinically relevant deviations as judged by the investigator;

- Must be willing and able to communicate and participate in the whole study;

- Must have regular bowel movements (i.e. average stool production of =1 and =3 stools
per day);

- Must provide written informed consent;

- Must agree to use an adequate method of contraception

Exclusion Criteria:

- Females;

- Subjects who have received any IMP in a clinical research study within the previous 3
months;

- Subjects who are study site employees, or immediate family members of a study site or
sponsor employee;

- Subjects who have previously been enrolled in this study;

- History of any drug or alcohol abuse in the past 2 years;

- Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, 25 mL
of 40% spirit or a 125 mL glass of wine);

- Current smokers and those who have smoked within the last 12 months. A breath carbon
monoxide reading of greater than 10 ppm at screening and admission;

- Current users of e-cigarettes and nicotine replacement products and those who have
used these products within the last 12 months

- Radiation exposure, including that from the present study, excluding background
radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv
in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker,
as defined in the Ionising Radiation Regulations 1999, shall participate in the study;

- Subjects who do not have suitable veins for multiple venepunctures/cannulation as
assessed by the investigator at screening;

- Clinically significant abnormal biochemistry, haematology or urinalysis as judged by
the investigator;

- Positive drugs of abuse test result;

- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or
human immunodeficiency virus (HIV) results;

- Evidence of renal impairment at screening, as indicated by an estimated creatinine
clearance of <90 mL/min using the Cockcroft-Gault equation;

- History of cardiovascular, neurological, renal, hepatic, chronic respiratory or
gastrointestinal disease, or clinically significant psychiatric history as judged by
the investigator;

- Serious adverse reaction or serious hypersensitivity to any drug or the formulation
excipients

- Presence or history of clinically significant allergy requiring treatment, as judged
by the investigator. Hayfever is allowed unless it is active;

- Donation or loss of greater than 400 mL of blood within the previous 3 months;

- Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other
than 2 g per day paracetamol) or herbal remedies in the 14 days before IMP
administration. Exceptions may apply on a case by case basis, if considered not to
interfere with the objectives of the study, as agreed by the PI and sponsor's medical
monitor;

- Failure to satisfy the investigator of fitness to participate for any other reason.



Age minimum: 30 Years
Age maximum: 65 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: [14C]-BIA 9-1067

Primary Outcome(s)

Mass balance recovery of total radioactivity in all (urine, faeces and expired air combined) cumulative recovery (CumAe) expressed as a percentage of the administered dose (Cum%Ae) [Time Frame: Urine and faeces: pre-dose,0,0.25,0.5,0.75,1,1.5, 2, 3, 4, 6,8,12,18,24,36,48,72,96,120,144,168,240,312,408,504,648 hours after dosing. Expired air: Pre-dose, 0.5,1,1.5,2,4,6,8,12,18,24,36,48,72,96,120,168,240,312,408,504 hours after dosing.]

Mass balance recovery of total radioactivity in all (urine, faeces and expired air combined) amount excreted (Ae) expressed as a percentage of the administered dose (%Ae) [Time Frame: Urine and faeces: pre-dose,0,0.25,0.5,0.75,1,1.5, 2, 3, 4, 6,8,12,18,24,36,48,72,96,120,144,168,240,312,408,504,648 hours after dosing. Expired air: Pre-dose, 0.5,1,1.5,2,4,6,8,12,18,24,36,48,72,96,120,168,240,312,408,504 hours after dosing.]

Secondary Outcome(s)

AUC0-t: area under the curve from 0 time to last measurable concentration [Time Frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 240, 408, 504 hours after dosing]

Cmax: maximum observed concentration [Time Frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 240, 408, 504 hours after dosing]

Tlag: the elapsed time from dosing at which analyte was first quantifiable in a concentration vs time profile [Time Frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 240, 408, 504 hours after dosing]

Tmax: the time from dosing at which Cmax was apparent [Time Frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 240, 408, 504 hours after dosing]

Secondary ID(s)

BIA-91067-130

Source(s) of Monetary Support

Please refer to primary and secondary sponsors