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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Carbon-14 BIA 28-6156
Sponsored by
Bial R&D Investments, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder
  • Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
  • Presence or history of clinically significant allergy requiring treatment. Hay fever is allowed unless it is active
  • Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
  • Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day) in the 14 days before IMP administration.
  • Failure to satisfy the investigator of fitness to participate for any other reason

Sites / Locations

  • Quotient Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Carbon-14 BIA 28-6156

Arm Description

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

Outcomes

Primary Outcome Measures

Mass balance recovery of total radioactivity in all excreta (urine and faeces)
CumAe and Cum%Ae
Collection of urine and faecal samples for total radioactivity
Total radioactivity for total recovery of Carbon-14 BIA28-6156
Collection of plasma samples for metabolite profiling
Collection of major metabolites for metabolite profiling of BIA28-6156
Collection of plasma samples for structural identification
Identification of chemical structure of major metabolites of BIA28-6156
Collection of whole blood samples for total radioactivity
Total radioactivity for total recovery of Carbon-14 BIA28-6156

Secondary Outcome Measures

Determination of routes and rates of elimination of Carbon-14 BIA 28-6156
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
Measurement of BIA 28-6156 PK parameters
Evaluation of whole blood: plasma concentration ratios for total radioactivity
Adverse events (AEs)

Full Information

First Posted
November 18, 2021
Last Updated
January 25, 2022
Sponsor
Bial R&D Investments, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT05220072
Brief Title
Mass Balance Recovery and Metabolite Identification of Carbon-14 BIA 28-6156
Official Title
An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of Carbon-14 BIA 28-6156 in Healthy Male Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 28, 2021 (Actual)
Primary Completion Date
October 16, 2021 (Actual)
Study Completion Date
October 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bial R&D Investments, S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is an open-label, single-dose, single period study in healthy male subjects. It is planned to enroll 6 subjects. All subjects will receive a single oral dose Carbon-14 BIA 28-6156. Blood samples will be collected at regular intervals for PK analysis, mass balance and metabolite profiling and identification from pre-dose up to 240 h post-dose. Urine and faecal samples will be collected at regular intervals for mass balance and metabolite profiling and identification from pre-dose until the mass balance criteria have been met.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carbon-14 BIA 28-6156
Arm Type
Experimental
Arm Description
Healthy volunteers receive a single dose of Carbon-14 BIA 28-6156
Intervention Type
Drug
Intervention Name(s)
Carbon-14 BIA 28-6156
Intervention Description
Carbon-14 BIA 28-6156 60 mg, containing NMT 3.7 MBq Carbon-14
Primary Outcome Measure Information:
Title
Mass balance recovery of total radioactivity in all excreta (urine and faeces)
Description
CumAe and Cum%Ae
Time Frame
Urine: Day 1 through Day 11, Faeces: Day -1 through Day 11
Title
Collection of urine and faecal samples for total radioactivity
Description
Total radioactivity for total recovery of Carbon-14 BIA28-6156
Time Frame
Urine and Faeces: Pre-dose until 288 hours post-dose
Title
Collection of plasma samples for metabolite profiling
Description
Collection of major metabolites for metabolite profiling of BIA28-6156
Time Frame
Pre-dose until 240 hours post-dose
Title
Collection of plasma samples for structural identification
Description
Identification of chemical structure of major metabolites of BIA28-6156
Time Frame
Pre-dose until 240 hours post-dose
Title
Collection of whole blood samples for total radioactivity
Description
Total radioactivity for total recovery of Carbon-14 BIA28-6156
Time Frame
Pre-dose until 240 hours post-dose
Secondary Outcome Measure Information:
Title
Determination of routes and rates of elimination of Carbon-14 BIA 28-6156
Time Frame
Day 1 through Day 11
Title
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
Time Frame
Urine and Faeces: Day 1 through Day 11, Plasma: Day 1 through Day 7
Title
Measurement of BIA 28-6156 PK parameters
Time Frame
Day 1 through Day 11
Title
Evaluation of whole blood: plasma concentration ratios for total radioactivity
Time Frame
Day 1 through Day 7
Title
Adverse events (AEs)
Time Frame
Screening through Day 11

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients Presence or history of clinically significant allergy requiring treatment. Hay fever is allowed unless it is active Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day) in the 14 days before IMP administration. Failure to satisfy the investigator of fitness to participate for any other reason
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Somasekhara Menakuru, MBBS,MS,MRCS,DPM,MFPM
Organizational Affiliation
Quotient Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quotient Sciences
City
Ruddington
State/Province
Nottingham
ZIP/Postal Code
NG11 6JS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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