Parkinson DiseasePhase 1NCT03116295
Bioavailability and Bioequivalence Study of Two Different Sources of Opicapone
A Phase 1 study testing Opicapone (OPC) in people with Parkinson Disease, run by Bial - Portela C S.A. at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the bioavailability and the bioequivalence between two active pharmaceutical ingredient (API) sources of opicapone (OPC) at two different dosage strengths (25 mg and 50 mg) after a single oral dose administration under fasting conditions in healthy male and female subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Opicapone (OPC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteGermany
- Study dates
- 20 Jun 2017to 28 Aug 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects signed and dated the ICF before any study-specific screening procedure.
- Male and female subjects, between 18 and 55 years of age (inclusive).
- BMI between 18 and 30 kg/m² inclusive.
- Subjects have a supine blood pressure (after at least 5 minutes rest in supine position) of: systolic blood pressure ≥90 and <140 mmHg, diastolic blood pressure ≥50 and <90 mmHg and a pulse rate ≥50 and ≤90 bpm (beats per minute).
- Subjects have no clinically relevant abnormal ECG parameters: heart rate ≥50 and ≤90 bpm, PR interval ≤ 220 milliseconds (ms), QRS duration ≤120 ms, QTcB interval ≤450 ms. No clinically relevant pathological findings in the 12-lead ECG.
- Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
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- Negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus antibodies (HCVab) and anti-HIV antibodies (HIV-1 and HIV-2 Ab) at screening.
- Clinical laboratory test results clinically acceptable at screening and admission to each treatment period.
- Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period.
- Non-smokers or ex-smokers for at least 3 months.
- If female, the pregnancy test at screening and at admission to each treatment period must be negative.
- Female subjects are of non-childbearing potential (postmenopausal [no menses for at least 1 year] or surgically sterile [tubal ligation, hysterectomy or bilateral oophorectomy]). Female subjects of childbearing potential must use an acceptable method of non-hormonal method of contraception and should be informed of the potential risks associated with becoming pregnant while enrolled within a clinical investigation. Acceptable methods for this study are: intrauterine device, condom or occlusive cap (diaphragm or cervical or vault caps) with spermicide, true abstinence or vasectomized male partner, provided that he is the sole partner of that subject).
- Able to participate, and willing to give written ICF and comply with the study restrictions.
Who cannot join
- Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders, or have a clinically relevant surgical history.
- Subjects with clinically relevant neurologic or psychiatric illness.
- Subjects with a history of symptomatic orthostatic hypotension.
- Subjects with clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) as judged by the Principal investigator.
- Subjects with hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption
- Subjects with clinically significant findings in laboratory tests, particularly any abnormality in the coagulation tests, or any abnormality in the kidney function tests especially creatinine above 1.2 x upper limit of normal (ULN) and/or liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST],) above 1.25 x ULN confirmed by two repeated measurements, when it is checked during the screening laboratory tests.
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- Subjects with a history of relevant atopy or drug hypersensitivity.
- Subjects with a history of alcoholism and/or drug abuse.
- Consumption of more than 14 units of alcohol per week [1 unit of alcohol = 280 ml beer (3-4°) = 100 ml wine (10-12°) = 30 ml spirits (40°)].
- Subjects with a significant infection or known inflammatory process at screening or admission to each treatment period.
- Subjects with acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea, heartburn) at the time of screening or admission to each treatment period.
- Use of medicines within 2 weeks prior to the planned first drug administration that may affect the safety or other study assessments, in the investigator's opinion (excluding single use of up to 1000 mg paracetamol).
- Use of any investigational drug or participation in any clinical trial within 30 days or 10 half-life, whatever is longer, prior to the planned first drug administration.
- Donation or receipt of any blood or blood products within the 2 months prior to the planned first drug administration.
- Subjects who are vegetarians, vegans or have medical dietary restrictions.
- Subjects who cannot communicate reliably with the investigator.
- Subjects who are unlikely to co-operate with the requirements of the study.
- Subjects who are unwilling or unable to give written informed consent.
- If female: She is pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative, Randomized, Open-label, Fasted, Single-dose, 2-way Crossover Bioavailability and Bioequivalence Study of Two Different Sources of Opicapone in Healthy Subjects
The purpose of this study is to evaluate the bioavailability and the bioequivalence between two active pharmaceutical ingredient (API) sources of opicapone (OPC) at two different dosage strengths (25 mg and 50 mg) after a single oral dose administration under fasting conditions in healthy male and female subjects.
Read the detailed description
Single-center, fasted, open-label, randomized, gender-balanced, single-dose, laboratory blinded, two-periods, two-sequence, crossover study in 2 groups of subjects.
In Group 1, subjects will receive randomly in Period 1 and 2, either a single 25 mg dose of OPC approved formulation [AF] or a single 25 mg dose of OPC formulation to be submitted for approval [NF].
In Group 2, subjects will receive randomly on Period 1 and 2, either a single 50 mg dose of OPC (AF), or a single 50 mg dose of OPC (NF
- Conditions
- Parkinson Disease
- Being tested
- Opicapone (OPC)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opicapone (OPC)Drug
Also called Ongentys, BIA 9-1067
Test treatment: 25 mg or 50 mg of OPC hard capsule (new API source NF) Reference treatment: Ongentys® 25 mg or 50 mg of OPC hard capsule (current API source - AF).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - 25 mg OPC | Experimental | In Group 1, subjects will receive randomly in Period 1 and 2, either a single 25 mg dose of OPC [AF] or a single 25 mg dose of OPC [NF]. Treatments will be administered in the fasting state, the subjects having fasted for at least 10 hours Receives: Drug: Opicapone (OPC) |
| Group 2 - 50 mg OPC | Experimental | In Group 2, subjects will receive randomly on Period 1 and 2, either a single 50 mg dose of OPC [AF], or a single 50 mg dose of OPC [NF]. Treatments will be administered in the fasting state, the subjects having fasted for at least 10 hours Receives: Drug: Opicapone (OPC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed drug concentration. (Cmax) - Period 1
Pharmacokinetic variables
Measured: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Time of the maximum drug concentration (tmax) - Period 1
Pharmacokinetic variables
Measured: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Area under the plasma concentration-time curve calculated from time zero (time of drug administration) to the latest time point with a quantifiable plasma concentration (AUC0-t) - Period 1
Pharmacokinetic variables
Measured: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) - Period 1
Pharmacokinetic variables
Measured: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Apparent terminal elimination rate constant - Period 1
Pharmacokinetic variables
Measured: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Apparent terminal elimination half-life (t1/2) - Period 1
Pharmacokinetic variables
Measured: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Apparent total body clearance (CL/F) - Period 1
Pharmacokinetic variables
Measured: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Apparent volume of distribution (V/F) - Period 1
Pharmacokinetic variables
Measured: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Maximum observed drug concentration (Cmax) - Period 2
Pharmacokinetic variables
Measured: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Time of the maximum drug concentration (tmax) - Period 2
Pharmacokinetic variables
Measured: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Area under the plasma concentration-time curve calculated from time zero (time of drug administration) to the latest time point with a quantifiable plasma concentration (AUC0-t) - Period 2
Pharmacokinetic variables
Measured: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) - Period 2
Pharmacokinetic variables
Measured: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Apparent terminal elimination rate constant - Period 2
Pharmacokinetic variables
Measured: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Apparent terminal elimination half-life (t1/2) - Period 2
Pharmacokinetic variables
Measured: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Apparent total body clearance (CL/F) - Period 2
Pharmacokinetic variables
Measured: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Apparent volume of distribution (V/F) - Period 2
Pharmacokinetic variables
Measured: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start20 Jun 2017
- Primary completion28 Aug 2017
- Study completion28 Aug 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 56 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
- NCT03116295
- Sponsor's protocol ID
- BIA-91067-129
- Status last verified
- Oct 2018
- First submitted
- 12 Apr 2017
- Last updated
- 15 Oct 2018
- 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 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative, Randomized, Open-label, Fasted, Single-dose, 2-way Crossover Bioavailability and Bioequivalence Study of Two Different Sources of Opicapone in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03116295
- Acronym / sponsor ID
- BIA-91067-129
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 28 Aug 2017 (actual)
- Study completion
- 28 Aug 2017 (actual)
- First posted
- 17 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 of this study is to evaluate the bioavailability and the bioequivalence between two active pharmaceutical ingredient (API) sources of opicapone (OPC) at two different dosage strengths (25 mg and 50 mg) after a single oral dose administration under fasting conditions in healthy male and female subjects.
Detailed description
Single-center, fasted, open-label, randomized, gender-balanced, single-dose, laboratory blinded, two-periods, two-sequence, crossover study in 2 groups of subjects.
In Group 1, subjects will receive randomly in Period 1 and 2, either a single 25 mg dose of OPC approved formulation [AF] or a single 25 mg dose of OPC formulation to be submitted for approval [NF].
In Group 2, subjects will receive randomly on Period 1 and 2, either a single 50 mg dose of OPC (AF), or a single 50 mg dose of OPC (NF
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - 25 mg OPC | Experimental | Drug: Opicapone (OPC)In Group 1, subjects will receive randomly in Period 1 and 2, either a single 25 mg dose of OPC [AF] or a single 25 mg dose of OPC [NF]. Treatments will be administered in the fasting state, the subjects having fasted for at least 10 hours |
| Group 2 - 50 mg OPC | Experimental | Drug: Opicapone (OPC)In Group 2, subjects will receive randomly on Period 1 and 2, either a single 50 mg dose of OPC [AF], or a single 50 mg dose of OPC [NF]. Treatments will be administered in the fasting state, the subjects having fasted for at least 10 hours |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Subjects signed and dated the ICF before any study-specific screening procedure.
- Male and female subjects, between 18 and 55 years of age (inclusive).
- BMI between 18 and 30 kg/m² inclusive.
- Subjects have a supine blood pressure (after at least 5 minutes rest in supine position) of: systolic blood pressure ≥90 and <140 mmHg, diastolic blood pressure ≥50 and <90 mmHg and a pulse rate ≥50 and ≤90 bpm (beats per minute).
- Subjects have no clinically relevant abnormal ECG parameters: heart rate ≥50 and ≤90 bpm, PR interval ≤ 220 milliseconds (ms), QRS duration ≤120 ms, QTcB interval ≤450 ms. No clinically relevant pathological findings in the 12-lead ECG.
Key exclusion criteria (19 listed)
- Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders, or have a clinically relevant surgical history.
- Subjects with clinically relevant neurologic or psychiatric illness.
- Subjects with a history of symptomatic orthostatic hypotension.
- Subjects with clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) as judged by the Principal investigator.
- Subjects with hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption
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 |
|---|---|---|
| Opicapone (OPC)Also: Ongentys, BIA 9-1067Test treatment: 25 mg or 50 mg of OPC hard capsule (new API source NF) Reference treatment: Ongentys® 25 mg or 50 mg of OPC hard capsule (current API source - AF). | Drug | Group 1 - 25 mg OPC, Group 2 - 50 mg OPC |
Primary outcome
Maximum observed drug concentration. (Cmax) - Period 1
Time frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Pharmacokinetic variables
Time of the maximum drug concentration (tmax) - Period 1
Time frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Pharmacokinetic variables
Area under the plasma concentration-time curve calculated from time zero (time of drug administration) to the latest time point with a quantifiable plasma concentration (AUC0-t) - Period 1
Time frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Pharmacokinetic variables
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) - Period 1
Time frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Pharmacokinetic variables
Apparent terminal elimination rate constant - Period 1
Time frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Pharmacokinetic variables
Apparent terminal elimination half-life (t1/2) - Period 1
Time frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Pharmacokinetic variables
Apparent total body clearance (CL/F) - Period 1
Time frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Pharmacokinetic variables
Apparent volume of distribution (V/F) - Period 1
Time frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Pharmacokinetic variables
Maximum observed drug concentration (Cmax) - Period 2
Time frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Pharmacokinetic variables
Time of the maximum drug concentration (tmax) - Period 2
Time frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Pharmacokinetic variables
Area under the plasma concentration-time curve calculated from time zero (time of drug administration) to the latest time point with a quantifiable plasma concentration (AUC0-t) - Period 2
Time frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Pharmacokinetic variables
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) - Period 2
Time frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Pharmacokinetic variables
Apparent terminal elimination rate constant - Period 2
Time frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Pharmacokinetic variables
Apparent terminal elimination half-life (t1/2) - Period 2
Time frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Pharmacokinetic variables
Apparent total body clearance (CL/F) - Period 2
Time frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Pharmacokinetic variables
Apparent volume of distribution (V/F) - Period 2
Time frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose
Pharmacokinetic variables
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 15 Oct 2018.
- 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 Opicapone (OPC) in people with Parkinson Disease, run by Bial - Portela C S.A. at 1 site in Germany.
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 13 inclusion and 19 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 15 Oct 2018. 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 Germany. 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 drug concentration. (Cmax) - Period 1 (time frame: pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose). The study lists 16 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 15 Oct 2018.