Parkinson DiseasePhase 1NCT03119194
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-BIA 9-1067
A Phase 1 study testing [14C]-BIA 9-1067 in people with Parkinson Disease, run by Bial - Portela C S.A. at 1 site in United Kingdom.
Trial 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. 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?
- [14C]-BIA 9-1067
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Jan 2017to 27 Apr 2017
- 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;
- 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;
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- 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
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Clinical
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 [14C]-BIA 9-1067 in Healthy Male Subjects
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.
Read the detailed description
This is an open-label, single-dose, single-period, non-randomised study in healthy male subjects. Subjects will be screened for eligibility to participate in the study between 28 and 2 days before dosing. Eligible subjects will be admitted to the clinical unit on the evening of the day before dosing (Day -1). Subjects will be dosed on the morning of Day 1 following an overnight fast of approximately 8 h. Blood, urine, faeces and expired air will be collected at predefined time points for mass balance and PK analysis. Subjects will remain resident in the clinic until the morning of Day 22, when they will be discharged as a group.
Single dose administration on a single occasion. The estimated duration of the study from screening until the final return visit is approximately 3.5 months.
- Conditions
- Parkinson Disease
- Being tested
- [14C]-BIA 9-1067
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-BIA 9-1067Drug
1 × 100 mg capsule, Oral
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: [14C]-BIA 9-1067 |
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 (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
Measured: 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
Measured: 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
Pharmacokinetic Data Analysis for BIA 9-1067 and its metabolites, BIA 9-1103 and BIA 9-4588
Measured: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 240, 408, 504 hours after dosing
Cmax: maximum observed concentration
Pharmacokinetic Data Analysis for BIA 9-1067 and its metabolites, BIA 9-1103 and BIA 9-4588
Measured: 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
Pharmacokinetic Data Analysis for BIA 9-1067 and its metabolites, BIA 9-1103 and BIA 9-4588
Measured: 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
Pharmacokinetic Data Analysis for BIA 9-1067 and its metabolites, BIA 9-1103 and BIA 9-4588
Measured: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 240, 408, 504 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start27 Jan 2017
- Primary completion27 Apr 2017
- Study completion27 Apr 2017
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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119194
- Sponsor's protocol ID
- BIA-91067-130
- Status last verified
- Aug 2017
- First submitted
- 13 Apr 2017
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. 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 [14C]-BIA 9-1067 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03119194
- Acronym / sponsor ID
- BIA-91067-130
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- 27 Jan 2017 (actual)
- Primary completion
- 27 Apr 2017 (actual)
- Study completion
- 27 Apr 2017 (actual)
- First posted
- 18 Apr 2017 (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 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.
Detailed description
This is an open-label, single-dose, single-period, non-randomised study in healthy male subjects. Subjects will be screened for eligibility to participate in the study between 28 and 2 days before dosing. Eligible subjects will be admitted to the clinical unit on the evening of the day before dosing (Day -1). Subjects will be dosed on the morning of Day 1 following an overnight fast of approximately 8 h. Blood, urine, faeces and expired air will be collected at predefined time points for mass balance and PK analysis. Subjects will remain resident in the clinic until the morning of Day 22, when they will be discharged as a group.
Single dose administration on a single occasion. The estimated duration of the study from screening until the final return visit is approximately 3.5 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reguimen A - [14C]-BIA 9-1067 | Experimental | Drug: [14C]-BIA 9-1067100 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (20 listed)
- 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;
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 |
|---|---|---|
| [14C]-BIA 9-10671 × 100 mg capsule, Oral | Drug | Reguimen A - [14C]-BIA 9-1067 |
Primary outcome
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)
Time frame: 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 of total radioactivity in urine, faeces and expired air
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)
Time frame: 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 of total radioactivity in urine, faeces and expired air
4 secondary outcomes
Tlag: the elapsed time from dosing at which analyte was first quantifiable in a concentration vs time profile
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 240, 408, 504 hours after dosing
Cmax: maximum observed concentration
Time frame: 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
Time frame: 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
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 240, 408, 504 hours after dosing
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 24 Aug 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 [14C]-BIA 9-1067 in people with Parkinson Disease, run by Bial - Portela C 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 10 inclusion and 20 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 24 Aug 2017. 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 (urine, faeces and expired air combined) amount excreted (Ae) expressed as a percentage of the administered dose (%Ae) (time frame: 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.). The study lists 2 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 24 Aug 2017.