Parkinson DiseasePhase 1NCT05220072
Mass Balance Recovery and Metabolite Identification of Carbon-14 BIA 28-6156
A Phase 1 study testing Carbon-14 BIA 28-6156 in people with Parkinson Disease, run by Bial R&D Investments, S.A. at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Carbon-14 BIA 28-6156
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Aug 2021to 16 Oct 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Sciences
Ruddington, Nottingham, NG11 6JS
About this study
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
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Carbon-14 BIA 28-6156
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon-14 BIA 28-6156Drug
Carbon-14 BIA 28-6156 60 mg, containing NMT 3.7 MBq Carbon-14
| Study group | Role | What they receive |
|---|---|---|
| Carbon-14 BIA 28-6156 | Experimental | Healthy volunteers receive a single dose of Carbon-14 BIA 28-6156 Receives: Drug: Carbon-14 BIA 28-6156 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass balance recovery of total radioactivity in all excreta (urine and faeces)
CumAe and Cum%Ae
Measured: 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
Measured: 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
Measured: Pre-dose until 240 hours post-dose
Collection of plasma samples for structural identification
Identification of chemical structure of major metabolites of BIA28-6156
Measured: 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
Measured: Pre-dose until 240 hours post-dose
Secondary outcomes (5)
Determination of routes and rates of elimination of Carbon-14 BIA 28-6156
Measured: 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
Measured: Urine and Faeces: Day 1 through Day 11, Plasma: Day 1 through Day 7
Measurement of BIA 28-6156 PK parameters
Measured: Day 1 through Day 11
Evaluation of whole blood: plasma concentration ratios for total radioactivity
Measured: Day 1 through Day 7
Adverse events (AEs)
Measured: Screening through Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start28 Aug 2021
- Primary completion16 Oct 2021
- Study completion16 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial R&D Investments, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Somasekhara Menakuru, MBBS,MS,MRCS,DPM,MFPM, Principal investigator, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220072
- Sponsor's protocol ID
- BIA 28-6156-106
- Status last verified
- May 2025
- First submitted
- 18 Nov 2021
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05220072
- Acronym / sponsor ID
- BIA 28-6156-106
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Bial R&D Investments, S.A.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2021 (actual)
- Primary completion
- 16 Oct 2021 (actual)
- Study completion
- 16 Oct 2021 (actual)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carbon-14 BIA 28-6156 | Experimental | Drug: Carbon-14 BIA 28-6156Healthy volunteers receive a single dose of Carbon-14 BIA 28-6156 |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbon-14 BIA 28-6156Carbon-14 BIA 28-6156 60 mg, containing NMT 3.7 MBq Carbon-14 | Drug | Carbon-14 BIA 28-6156 |
Primary outcome
Mass balance recovery of total radioactivity in all excreta (urine and faeces)
Time frame: Urine: Day 1 through Day 11, Faeces: Day -1 through Day 11
CumAe and Cum%Ae
Collection of urine and faecal samples for total radioactivity
Time frame: Urine and Faeces: Pre-dose until 288 hours post-dose
Total radioactivity for total recovery of Carbon-14 BIA28-6156
Collection of plasma samples for metabolite profiling
Time frame: Pre-dose until 240 hours post-dose
Collection of major metabolites for metabolite profiling of BIA28-6156
Collection of plasma samples for structural identification
Time frame: Pre-dose until 240 hours post-dose
Identification of chemical structure of major metabolites of BIA28-6156
Collection of whole blood samples for total radioactivity
Time frame: Pre-dose until 240 hours post-dose
Total radioactivity for total recovery of Carbon-14 BIA28-6156
5 secondary outcomes
Determination of routes and rates of elimination of Carbon-14 BIA 28-6156
Time frame: 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
Time frame: Urine and Faeces: Day 1 through Day 11, Plasma: Day 1 through Day 7
Measurement of BIA 28-6156 PK parameters
Time frame: Day 1 through Day 11
Evaluation of whole blood: plasma concentration ratios for total radioactivity
Time frame: Day 1 through Day 7
Adverse events (AEs)
Time frame: Screening through Day 11
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Somasekhara Menakuru, MBBS,MS,MRCS,DPM,MFPM principal investigator
Quotient Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Carbon-14 BIA 28-6156 in people with Parkinson Disease, run by Bial R&D Investments, S.A. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mass balance recovery of total radioactivity in all excreta (urine and faeces) (time frame: Urine: Day 1 through Day 11, Faeces: Day -1 through Day 11). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.