Parkinson's Disease (PD)Phase 1NCT02169414
Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics
A Phase 1 study testing BIA 9-1067 5 mg, BIA 9-1067 25 mg and levodopa/carbidopa 100/25 in people with Parkinson's Disease (PD), run by Bial - Portela C S.A. at 1 site in France.
Trial summary
The purpose of this study is to determine the effect of BIA 9 1067 (5 mg, 15 mg and 50 mg) in steady-state conditions on the levodopa pharmacokinetics of a single dose of immediate-release levodopa/carbidopa 100/25 mg and of a single dose of immediate-release levodopa/benserazide 100/25 mg. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- BIA 9-1067 5 mg, BIA 9-1067 25 mg and levodopa/carbidopa 100/25
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to Jul 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- able to participate and willing to give written informed consent;
- male and female subjects;
- aged 18 to 45 years, inclusive;
- body mass index (BMI) between 18 and 30 kg/m2;
- healthy as determined by the Investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, complete neurological examination and 12-lead electrocardiogram (ECG);
- negative tests for hepatitis B surface (HBs) antigen, anti-hepatitis C virus (HCV), human immunodeficiency virus-1 (HIV-1) and HIV-2 antibodies at screening;
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- negative screen for drugs of abuse and alcohol at screening and admission to the treatment period;
- non-smokers or ex-smokers for at least 3 months;
- if sexually active, agreed to use a medically acceptable form of contraception throughout the study;
- if female of childbearing potential, had a negative human chorionic gonadotropin (HCG) beta serum pregnancy test at screening and admission to the treatment period.
Who cannot join
- who did not conform to the above inclusion criteria, or in case of volunteers who had a clinically relevant surgical history, a clinically relevant family history; or who had a history of relevant atopy;
- who had a significant infection or known inflammatory process at screening or admission to the treatment period; acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea, heartburn) at the time of screening or admission to the treatment period;
- who were vegetarians, vegans or had medical dietary restrictions;
- who could not communicate reliably with the Investigator;
- who were unlikely to co-operate with the requirements of the study; history of hypersensitivity to BIA 9 1067, tolcapone, entacapone, levodopa, carbidopa, benserazide or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs;
- any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, dermatological, haematological, neurologic, or psychiatric disease;
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- any clinically significant illness in the previous 28 days before day 1 of this study; history of drug abuse within 1 year before study day 1; history of alcoholism within 1 year before day 1.
- Consumption of more than 50 g of ethanol per day (12.5 cL glass of 10° [10%] wine = 12 g; 4 cL of aperitif, 42° [42%] whiskey = 17 g; 25 cL glass of 3° [3%] beer = 7.5 g; 25 cL glass of 6° [6%] beer = 15 g);
- poor motivation, intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with the protocol requirements or inability to cooperate adequately, inability to understand and to observe the instructions of the physician;
- donation of blood (i.e., 450 mL) within 60 days before study day 1;
- positive urine screening of ethyl alcohol or drugs of abuse upon admission to the treatment period;
- any history of tuberculosis and/or prophylaxis for tuberculosis; positive results to HIV, hepatitis B surface antigen (HBsAg) or anti-HCV tests;
- participation in any previous clinical study with BIA 9 1067;
- if female, being pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics of a Single-dose of Immediate Release 100/25 mg Levodopa/Carbidopa and 100/25 mg Levodopa/Benserazide in Healthy Subjects
The purpose of this study is to determine the effect of BIA 9 1067 (5 mg, 15 mg and 50 mg) in steady-state conditions on the levodopa pharmacokinetics of a single dose of immediate-release levodopa/carbidopa 100/25 mg and of a single dose of immediate-release levodopa/benserazide 100/25 mg.
Read the detailed description
A single-centre, randomized, double-blind, gender-balanced, placebo-controlled study in 4 groups of 18 healthy subjects each. This study consisted of a once-daily administration of BIA 9 1067 (5 mg, 15 mg or 50 mg) or placebo for 18 days. Twelve (12) hours after the BIA 9 1067 dose, a single-dose of levodopa/carbidopa 100/25 mg was administered on Day 11 and a single-dose of levodopa/benserazide 100/25 mg was administered on Day 18.
- Conditions
- Parkinson's Disease (PD)
- Being tested
- BIA 9-1067 5 mg, BIA 9-1067 25 mg, levodopa/carbidopa 100/25, Placebo, levodopa/benserazide 100/25 mg
- Keywords
- Parkinson's disease (PD), BIA 9-1067, Opicapone
- 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 9-1067 5 mgDrug
Also called OPC, Opicapone
OPC, Opicapone
BIA 9-1067 25 mgDrug
Also called OPC, Opicapone
OPC, Opicapone
levodopa/carbidopa 100/25Drug
Also called Sinemet®
immediate (standard) release levodopa/carbidopa 100/25
PlaceboDrug
Also called PLC, Placebo
PLC, Placebo
levodopa/benserazide 100/25 mgDrug
Also called Madopar®
immediate (standard) release levodopa/benserazide
| Study group | Role | What they receive |
|---|---|---|
| BIA 9-1067 5 mg | Experimental | 1 capsule of 5 mg + 2 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18. Receives: Drug: BIA 9-1067 5 mg; Drug: levodopa/carbidopa 100/25; Drug: Placebo; Drug: levodopa/benserazide 100/25 mg |
| BIA 9-1067 15 mg | Experimental | 3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18. Receives: Drug: BIA 9-1067 5 mg; Drug: levodopa/carbidopa 100/25; Drug: levodopa/benserazide 100/25 mg |
| BIA 9-1067 50 mg | Experimental | 2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18. Receives: Drug: BIA 9-1067 25 mg; Drug: levodopa/carbidopa 100/25; Drug: Placebo; Drug: levodopa/benserazide 100/25 mg |
| Placebo | Placebo comparator | 3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18. Receives: Drug: levodopa/carbidopa 100/25; Drug: Placebo; Drug: levodopa/benserazide 100/25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - Maximum Plasma Concentration of Levodopa (Levodopa/Carbidopa)
Cmax - Maximum plasma concentration of levodopa following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11
Measured: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.
Tmax - Time to Reach Maximum Plasma Concentration of Levodopa (Levodopa/Carbidopa)
Tmax - Time to Reach maximum plasma concentration of levodopa following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11
Measured: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.
AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity (Levodopa/Carbidopa)
Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11
Measured: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.
AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification. (Levodopa/Carbidopa)
AUC0-t - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to the last sampling time following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11
Measured: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.
Cmax - Maximum Plasma Concentration of Levodopa (Levodopa/Benserazide )
Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18
Measured: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.
Tmax - Time to Reach Maximum Plasma Concentration of Levodopa (Levodopa/Benserazide)
Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18
Measured: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.
AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity (Levodopa/Benserazide)
Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18
Measured: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.
AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification. (Levodopa/Benserazide)
Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18
Measured: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 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 posted23 Jun 2014 (estimated)
- Study startFeb 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's Disease (PD)Studies 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
- 74 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
- NCT02169414
- Sponsor's protocol ID
- BIA-91067-123
- Status last verified
- Nov 2015
- First submitted
- 24 Jan 2012
- Last updated
- 24 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics of a Single-dose of Immediate Release 100/25 mg Levodopa/Carbidopa and 100/25 mg Levodopa/Benserazide in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02169414
- Acronym / sponsor ID
- BIA-91067-123
- Conditions
- Parkinson's Disease (PD)
- Keywords
- Parkinson's disease (PD), BIA 9-1067, Opicapone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Posted 24 Dec 2015
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 determine the effect of BIA 9 1067 (5 mg, 15 mg and 50 mg) in steady-state conditions on the levodopa pharmacokinetics of a single dose of immediate-release levodopa/carbidopa 100/25 mg and of a single dose of immediate-release levodopa/benserazide 100/25 mg.
Detailed description
A single-centre, randomized, double-blind, gender-balanced, placebo-controlled study in 4 groups of 18 healthy subjects each. This study consisted of a once-daily administration of BIA 9 1067 (5 mg, 15 mg or 50 mg) or placebo for 18 days. Twelve (12) hours after the BIA 9 1067 dose, a single-dose of levodopa/carbidopa 100/25 mg was administered on Day 11 and a single-dose of levodopa/benserazide 100/25 mg was administered on Day 18.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BIA 9-1067 5 mg | Experimental | Drug: BIA 9-1067 5 mg, Drug: levodopa/carbidopa 100/25, Drug: Placebo, Drug: levodopa/benserazide 100/25 mg1 capsule of 5 mg + 2 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18. |
| BIA 9-1067 15 mg | Experimental | Drug: BIA 9-1067 5 mg, Drug: levodopa/carbidopa 100/25, Drug: levodopa/benserazide 100/25 mg3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18. |
| BIA 9-1067 50 mg | Experimental | Drug: BIA 9-1067 25 mg, Drug: levodopa/carbidopa 100/25, Drug: Placebo, Drug: levodopa/benserazide 100/25 mg2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18. |
| Placebo | Placebo comparator | Drug: levodopa/carbidopa 100/25, Drug: Placebo, Drug: levodopa/benserazide 100/25 mg3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- able to participate and willing to give written informed consent;
- male and female subjects;
- aged 18 to 45 years, inclusive;
- body mass index (BMI) between 18 and 30 kg/m2;
- healthy as determined by the Investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, complete neurological examination and 12-lead electrocardiogram (ECG);
Key exclusion criteria (14 listed)
- who did not conform to the above inclusion criteria, or in case of volunteers who had a clinically relevant surgical history, a clinically relevant family history; or who had a history of relevant atopy;
- who had a significant infection or known inflammatory process at screening or admission to the treatment period; acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea, heartburn) at the time of screening or admission to the treatment period;
- who were vegetarians, vegans or had medical dietary restrictions;
- who could not communicate reliably with the Investigator;
- who were unlikely to co-operate with the requirements of the study; history of hypersensitivity to BIA 9 1067, tolcapone, entacapone, levodopa, carbidopa, benserazide or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs;
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 9-1067 5 mgAlso: OPC, OpicaponeOPC, Opicapone | Drug | BIA 9-1067 15 mg, BIA 9-1067 5 mg |
| BIA 9-1067 25 mgAlso: OPC, OpicaponeOPC, Opicapone | Drug | BIA 9-1067 50 mg |
| levodopa/carbidopa 100/25Also: Sinemet®immediate (standard) release levodopa/carbidopa 100/25 | Drug | BIA 9-1067 15 mg, BIA 9-1067 5 mg, BIA 9-1067 50 mg, Placebo |
| PlaceboAlso: PLC, PlaceboPLC, Placebo | Drug | BIA 9-1067 5 mg, BIA 9-1067 50 mg, Placebo |
| levodopa/benserazide 100/25 mgAlso: Madopar®immediate (standard) release levodopa/benserazide | Drug | BIA 9-1067 15 mg, BIA 9-1067 5 mg, BIA 9-1067 50 mg, Placebo |
Primary outcome
Cmax - Maximum Plasma Concentration of Levodopa (Levodopa/Carbidopa)
Time frame: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.
Cmax - Maximum plasma concentration of levodopa following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11
Tmax - Time to Reach Maximum Plasma Concentration of Levodopa (Levodopa/Carbidopa)
Time frame: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.
Tmax - Time to Reach maximum plasma concentration of levodopa following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11
AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity (Levodopa/Carbidopa)
Time frame: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.
Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11
AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification. (Levodopa/Carbidopa)
Time frame: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.
AUC0-t - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to the last sampling time following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11
Cmax - Maximum Plasma Concentration of Levodopa (Levodopa/Benserazide )
Time frame: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.
Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18
Tmax - Time to Reach Maximum Plasma Concentration of Levodopa (Levodopa/Benserazide)
Time frame: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.
Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18
AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity (Levodopa/Benserazide)
Time frame: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.
Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18
AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification. (Levodopa/Benserazide)
Time frame: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose
Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 9-1067 5 mg, BIA 9-1067 25 mg and levodopa/carbidopa 100/25 in people with Parkinson's Disease (PD), run by Bial - Portela C S.A. at 1 site in France.
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 14 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 Dec 2015. 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 France. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 24 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cmax - Maximum Plasma Concentration of Levodopa (Levodopa/Carbidopa) (time frame: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.). 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 24 Dec 2015.