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

NCT03119194 | Completed Phase 1

• 1 other identifier: BIA-91067-130
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• 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)

  Mass balance of total radioactivity in urine, faeces and expired air

  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) cumulative recovery (CumAe) expressed as a percentage of the administered dose (Cum%Ae)

  Mass balance of total radioactivity in urine, faeces and expired air

  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 Outcomes (4)

• Tlag: the elapsed time from dosing at which analyte was first quantifiable in a concentration vs time profile

  Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 240, 408, 504 hours after dosing

• Cmax: maximum observed concentration

  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

  Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 240, 408, 504 hours after dosing

• AUC0-t: area under the curve from 0 time to last measurable concentration

  Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 240, 408, 504 hours after dosing

Study Arms (1)

Reguimen A - [14C]-BIA 9-1067

EXPERIMENTAL

100 mg \[14C\]-BIA 9-1067 Capsule containing not more than 3.3 MBq (89.2 µCi) 14C; will be administered with 240 mL water. Single dose administration on a single occasion.

Drug: [14C]-BIA 9-1067

Interventions

[14C]-BIA 9-1067 DRUG

1 × 100 mg capsule, Oral

Reguimen A - [14C]-BIA 9-1067

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

Quotient Clinical

Ruddington, Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

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: April 13, 2017
• First Posted: April 18, 2017
• Study Start: January 27, 2017
• Primary Completion: April 27, 2017
• Study Completion: April 27, 2017
• Last Updated: August 24, 2017

Record last verified: 2017-08

Locations

GB (1)