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

• Status: Completed
• Trial end date: 2017-04-27
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose is to and to assess the mass balance recovery after a single oral dose of [14C]-BIA 9-1067 and to provide plasma, urine and faecal samples for metabolite profiling and structural identification.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bial - Portela C S.A.
• Treatments: Opicapone

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.