Mass Balance Recovery and Metabolite Identification of Carbon-14 BIA 28-6156

NCT05220072 | Completed Phase 1

• 1 other identifier: BIA 28-6156-106
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to determine the absorption, distribution, metabolism and elimination (ADME) of BIA 28-6156 in humans, further explore the PK of BIA 28-6156, evaluate the extent of distribution of total radioactivity into blood cells, provide additional safety and tolerability information and collect samples for metabolite profiling and structural identification.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (5)

• Mass balance recovery of total radioactivity in all excreta (urine and faeces)

  CumAe and Cum%Ae

  Urine: Day 1 through Day 11, Faeces: Day -1 through Day 11

• Collection of urine and faecal samples for total radioactivity

  Total radioactivity for total recovery of Carbon-14 BIA28-6156

  Urine and Faeces: Pre-dose until 288 hours post-dose

• Collection of plasma samples for metabolite profiling

  Collection of major metabolites for metabolite profiling of BIA28-6156

  Pre-dose until 240 hours post-dose

• Collection of plasma samples for structural identification

  Identification of chemical structure of major metabolites of BIA28-6156

  Pre-dose until 240 hours post-dose

• Collection of whole blood samples for total radioactivity

  Total radioactivity for total recovery of Carbon-14 BIA28-6156

  Pre-dose until 240 hours post-dose

Secondary Outcomes (5)

• Determination of routes and rates of elimination of Carbon-14 BIA 28-6156

  Day 1 through Day 11

• Identification of the chemical structure of each metabolite accounting for more than 10% by AUC of circulating plasma total radioactivity and more than 10% of total radioactive dose

  Urine and Faeces: Day 1 through Day 11, Plasma: Day 1 through Day 7

• Measurement of BIA 28-6156 PK parameters

  Day 1 through Day 11

• Evaluation of whole blood: plasma concentration ratios for total radioactivity

  Day 1 through Day 7

• Adverse events (AEs)

  Screening through Day 11

Study Arms (1)

Carbon-14 BIA 28-6156

EXPERIMENTAL

Healthy volunteers receive a single dose of Carbon-14 BIA 28-6156

Drug: Carbon-14 BIA 28-6156

Interventions

Carbon-14 BIA 28-6156 DRUG

Carbon-14 BIA 28-6156 60 mg, containing NMT 3.7 MBq Carbon-14

Carbon-14 BIA 28-6156

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 aged 30 to 65 years inclusive
• Body mass index (BMI) of 18.0 to 35.0 kg/m2
• Must be willing and able to communicate and participate in the whole study
• Must have regular bowel movements
• Must provide written informed consent
• Must agree to adhere to contraception requirements

You may not qualify if:

• Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
• Subjects who are, or are immediate family members of, a study site or sponsor employee
• Evidence of current SARS-CoV-2 infection from results of diagnostic tests or from symptoms reported at screening or admission
• History of any drug or alcohol abuse in the past 2 years
• Regular alcohol consumption
• A confirmed positive alcohol breath test at screening or admission
• Current smokers and those who have smoked within the last 12 months.
• Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
• Subjects with pregnant or lactating partners
• 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.
• Subjects who do not have suitable veins for multiple venepunctures/cannulation
• Clinically significant abnormal clinical chemistry, haematology or urinalysis. Subjects with Gilbert's Syndrome are allowed.
• Confirmed positive drugs of abuse test result
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
• Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of \<80 mL/min using the Cockcroft-Gault equation

Sponsors & Collaborators

• Bial R&D Investments, S.A.: lead

Study Sites (1)

Quotient Sciences

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 Officials

• Somasekhara Menakuru, MBBS,MS,MRCS,DPM,MFPM

  Quotient Sciences

  PRINCIPAL INVESTIGATOR

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: November 18, 2021
• First Posted: February 2, 2022
• Study Start: August 28, 2021
• Primary Completion: October 16, 2021
• Study Completion: October 16, 2021
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)