Parkinson's DiseasePhase 1NCT02763800
Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202
A Phase 1 study testing BIA 3-202 in people with Parkinson's Disease, run by Bial - Portela C S.A. at 1 site in United Kingdom.
Trial summary
The objectives as stated in the study protocol were as follows: To investigate the safety and tolerability of three multiple dose regimens of BIA 3-202 (50 mg twice a day, 100 mg twice a day and 200 mg twice a day in healthy young male volunteers). Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- BIA 3-202
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2000to Jan 2001
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult males aged 18-35 years, with a body mass index (BMI) of 19-28 kg/m2.
- Subjects who were healthy as determined by pre-study medical history, physical examination and 12-lead ECG.
- Subjects who had clinical laboratory tests acceptable to the investigator.
- Subjects who were negative for HbsAg, anti-HCV and HIV I and II tests at screening.
- Subjects who were negative for drugs of abuse and alcohol tests at screening and admission.
- Subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per day.
- Subjects who were able and willing to give written informed consent.
Who cannot join
- Subjects who did not conform to the above inclusion criteria.
- Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders.
- Subjects who had a clinically relevant surgical history.
- Subjects who had a clinically relevant family history.
- Subjects who had a history of relevant atopy.
- Subjects who had a history of relevant drug hypersensitivity.
Show all 21Show fewer
- Subjects who had a history of alcoholism.
- Subjects who had a history of drug abuse.
- Subjects who consumed more than 28 units of alcohol a week.
- Subjects who had a significant infection or known inflammatory process on screening and/or admission.
- Subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhoea, heartburn).
- Subjects who had an acute infection such as influenza at the time of screening and/or admission.
- Subjects who had used prescription drugs within 4 weeks of first dosing.
- Subjects who had used over the counter medication, excluding routine vitamins but including mega dose vitamin therapy, within one week of first dosing.
- Subjects who had used any investigational drug and/or participated in any clinical trial within 3 months of their first admission to this study.
- Subjects who had previously received BIA 3-202.
- Subjects who had donated and/or received any blood or blood products within 3 months prior to screening.
- Subjects who were vegetarians, vegans and/or had medical dietary restrictions.
- Subjects who could not communicate reliably with the investigator.
- Subjects who were unlikely to co-operate with the requirements of the study.
- Subjects who were unwilling or unable to give written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-Blind, Randomised, Placebo-Controlled, Rising Multiple Dose Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202, in Young Healthy Volunteers
The objectives as stated in the study protocol were as follows:
- To investigate the safety and tolerability of three multiple dose regimens of BIA 3-202 (50 mg twice a day, 100 mg twice a day and 200 mg twice a day in healthy young male volunteers). Part A
- To characterise the steady state pharmacokinetic and pharmacodynamic profile of BIA 3-202 in healthy young males. Part A
- To investigate the safety and tolerability of a single multiple dose regimen (dose to be determined from Part A) of BIA 3-202, in healthy elderly volunteers. Part B
- To characterise the steady state pharmacokinetic and pharmacodynamic profile of a single multiple dose regimen (dose to be determined from Part A) of BIA 3- 202 in healthy elderly volunteers. Part B
Read the detailed description
This was designed as a single centre, phase I, double-blind, randomised, placebocontrolled study of three multiple rising doses in three sequential groups of 8 young male healthy volunteers (Part A) and a single group of healthy elderly volunteers (Part B).
In Part B, 12 healthy elderly volunteers were to be enrolled. Ten were to be randomly allocated to BIA 3-202 and two to placebo.
- Conditions
- Parkinson's Disease
- Being tested
- BIA 3-202, Placebo
- Keywords
- Parkinson's disease, Nebicapone
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIA 3-202Drug
BIA 3-202 (50, 100 and 200 mg) was administered in the form of oral tablets, given with 200 ml potable water.
PlaceboDrug
Matched placebo was administered in the form of oral tablets, given with 200 ml potable water
| Study group | Role | What they receive |
|---|---|---|
| Group 1: BIA 3-202 50 mg/placebo | Experimental | Group 1: BIA 3-202 50 mg/placebo on Day 1; BIA 3-202 50 mg/placebo b.i.d. on Days 3-8 inclusively; final single dose of BIA 3-202 50 mg/placebo on Day 9.
50 mg BIA 3-202: 5 x 10 mg BIA 3-202 tablets Receives: Drug: BIA 3-202; Drug: Placebo |
| Group 2: BIA 3-202 100 mg/placebo | Experimental | Group 2: BIA 3-202 100 mg/placebo on Day 1; BIA 3-202 100 mg/placebo b.i.d. on Days 3-8 inclusively; final single dose of BIA 3-202 100 mg/placebo on Day 9.
100 mg BIA 3-202: 1 x 100 mg BIA 3-202 tablet Receives: Drug: BIA 3-202; Drug: Placebo |
| Group 3: BIA 3-202 200 mg/placebo | Experimental | Group 3: BIA 3-202 200 mg/placebo on Day 1; BIA 3-202 200 mg/placebo b.i.d. on Days 3-8 inclusively; final single dose of BIA 3-202 200 mg/placebo on Day 9.
200 mg BIA 3-202: 2 x 100 mg BIA 3-202 tablets Receives: Drug: BIA 3-202; Drug: Placebo |
| Group 4: BIA 3-202 200 mg/placebo | Experimental | Group 4: BIA 3-202 200 mg/placebo on Day 1; BIA 3-202 200 mg/placebo t.i.d. on Days 3-8 inclusively; final single dose of BIA 3-202 200 mg/placebo on Day 9.
200 mg BIA 3-202: 2 x 100 mg BIA 3-202 tablets Receives: Drug: BIA 3-202; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) - D1
Measured: Day 1
Time of maximum observed concentration (tmax) - D1
Measured: Day 1
Area under the plasma concentration time curve to last measurable time point (AUC0-t) - D1
Measured: Day 1
Area under the plasma concentration time curve extrapolated to infinity (AUC0-∞) - D1
Measured: Day 1
Maximum observed plasma concentration (Cmax) - D9
Measured: Day 9
Time of maximum observed concentration (tmax) - D9
Measured: Day 9
Area under the plasma concentration time curve to last measurable time point (AUC0-t) - D9
Measured: Day 9
Area under the plasma concentration time curve extrapolated to infinity (AUC0-∞) - D9
Measured: Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startSep 2000
- Primary completionJan 2001
- Study completionJan 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 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
- NCT02763800
- Sponsor's protocol ID
- BIA-3202-02
- Status last verified
- May 2016
- First submitted
- 4 May 2016
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomised, Placebo-Controlled, Rising Multiple Dose Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202, in Young Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02763800
- Acronym / sponsor ID
- BIA-3202-02
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Nebicapone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- Sep 2000
- Primary completion
- Jan 2001 (actual)
- Study completion
- Jan 2001 (actual)
- First posted
- 5 May 2016 (estimated)
- 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 objectives as stated in the study protocol were as follows:
- To investigate the safety and tolerability of three multiple dose regimens of BIA 3-202 (50 mg twice a day, 100 mg twice a day and 200 mg twice a day in healthy young male volunteers). Part A
- To characterise the steady state pharmacokinetic and pharmacodynamic profile of BIA 3-202 in healthy young males. Part A
- To investigate the safety and tolerability of a single multiple dose regimen (dose to be determined from Part A) of BIA 3-202, in healthy elderly volunteers. Part B
- To characterise the steady state pharmacokinetic and pharmacodynamic profile of a single multiple dose regimen (dose to be determined from Part A) of BIA 3- 202 in healthy elderly volunteers. Part B
Detailed description
This was designed as a single centre, phase I, double-blind, randomised, placebocontrolled study of three multiple rising doses in three sequential groups of 8 young male healthy volunteers (Part A) and a single group of healthy elderly volunteers (Part B).
In Part B, 12 healthy elderly volunteers were to be enrolled. Ten were to be randomly allocated to BIA 3-202 and two to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: BIA 3-202 50 mg/placebo | Experimental | Drug: BIA 3-202, Drug: PlaceboGroup 1: BIA 3-202 50 mg/placebo on Day 1; BIA 3-202 50 mg/placebo b.i.d. on Days 3-8 inclusively; final single dose of BIA 3-202 50 mg/placebo on Day 9. 50 mg BIA 3-202: 5 x 10 mg BIA 3-202 tablets |
| Group 2: BIA 3-202 100 mg/placebo | Experimental | Drug: BIA 3-202, Drug: PlaceboGroup 2: BIA 3-202 100 mg/placebo on Day 1; BIA 3-202 100 mg/placebo b.i.d. on Days 3-8 inclusively; final single dose of BIA 3-202 100 mg/placebo on Day 9. 100 mg BIA 3-202: 1 x 100 mg BIA 3-202 tablet |
| Group 3: BIA 3-202 200 mg/placebo | Experimental | Drug: BIA 3-202, Drug: PlaceboGroup 3: BIA 3-202 200 mg/placebo on Day 1; BIA 3-202 200 mg/placebo b.i.d. on Days 3-8 inclusively; final single dose of BIA 3-202 200 mg/placebo on Day 9. 200 mg BIA 3-202: 2 x 100 mg BIA 3-202 tablets |
| Group 4: BIA 3-202 200 mg/placebo | Experimental | Drug: BIA 3-202, Drug: PlaceboGroup 4: BIA 3-202 200 mg/placebo on Day 1; BIA 3-202 200 mg/placebo t.i.d. on Days 3-8 inclusively; final single dose of BIA 3-202 200 mg/placebo on Day 9. 200 mg BIA 3-202: 2 x 100 mg BIA 3-202 tablets |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adult males aged 18-35 years, with a body mass index (BMI) of 19-28 kg/m2.
- Subjects who were healthy as determined by pre-study medical history, physical examination and 12-lead ECG.
- Subjects who had clinical laboratory tests acceptable to the investigator.
- Subjects who were negative for HbsAg, anti-HCV and HIV I and II tests at screening.
- Subjects who were negative for drugs of abuse and alcohol tests at screening and admission.
Key exclusion criteria (21 listed)
- Subjects who did not conform to the above inclusion criteria.
- Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders.
- Subjects who had a clinically relevant surgical history.
- Subjects who had a clinically relevant family history.
- Subjects who had a history of relevant atopy.
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 |
|---|---|---|
| BIA 3-202BIA 3-202 (50, 100 and 200 mg) was administered in the form of oral tablets, given with 200 ml potable water. | Drug | Group 1: BIA 3-202 50 mg/placebo, Group 2: BIA 3-202 100 mg/placebo, Group 3: BIA 3-202 200 mg/placebo, Group 4: BIA 3-202 200 mg/placebo |
| PlaceboMatched placebo was administered in the form of oral tablets, given with 200 ml potable water | Drug | Group 1: BIA 3-202 50 mg/placebo, Group 2: BIA 3-202 100 mg/placebo, Group 3: BIA 3-202 200 mg/placebo, Group 4: BIA 3-202 200 mg/placebo |
Primary outcome
Maximum observed plasma concentration (Cmax) - D1
Time frame: Day 1
Time of maximum observed concentration (tmax) - D1
Time frame: Day 1
Area under the plasma concentration time curve to last measurable time point (AUC0-t) - D1
Time frame: Day 1
Area under the plasma concentration time curve extrapolated to infinity (AUC0-∞) - D1
Time frame: Day 1
Maximum observed plasma concentration (Cmax) - D9
Time frame: Day 9
Time of maximum observed concentration (tmax) - D9
Time frame: Day 9
Area under the plasma concentration time curve to last measurable time point (AUC0-t) - D9
Time frame: Day 9
Area under the plasma concentration time curve extrapolated to infinity (AUC0-∞) - D9
Time frame: Day 9
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 5 May 2016.
- 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.
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 BIA 3-202 in people with Parkinson's 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 7 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 5 May 2016. 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?
Maximum observed plasma concentration (Cmax) - D1 (time frame: Day 1). The study lists 8 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 5 May 2016.