Parkinson's Disease (PD)Phase 1NCT02170376

The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics

A Phase 1 study testing BIA 9-1067, Entacapone and Levodopa/carbidopa in people with Parkinson's Disease (PD), run by Bial - Portela C S.A. at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine the effect of repeated dosing of once-daily 25, 50 and 75 mg opicapone (OPC, development code BIA 9-1067) on the levodopa pharmacokinetics (PK), in comparison to placebo and 200 mg entacapone (ENT). 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, Entacapone and Levodopa/carbidopa
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteFrance
Study dates: Sep 2011to Jan 2012
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

Healthy male and female volunteers 18 to 45 years old (inclusive),
Body Mass Index (BMI) in normal range (18-30 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 ECG (electrocardiogram),
Negative tests for Hepatitis B surface antigen (HBsAG), anti-Hepatitis C virus (HCV) antibodies and Human immunodeficiency virus (HIV) -1 and HIV-2 antibodies at screening,
Negative screen for drugs of abuse and alcohol at screening and admission to the treatment period,
If of childbearing potential (i.e. except if they had been sterilized for at least 3 months or postmenopausal for at least one year - the menopause was defined by a follicule stimulating hormone (FSH) level > 30 IU/L): used a non hormonal acceptable contraception method, i.e. intra-uterine device, condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository for all the duration of the study,

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If female of childbearing potential, had a negative human chorionic gonadotropin (HCG) beta serum pregnancy test at screening and urinary pregnancy test at admission to both ambulatory and confinement periods,
Non-smokers or ex-smokers for at least 3 months,
Able to communicate well with the Investigator and research staff and to comply with the requirements of the entire study,
Provision of written informed consent to participate as shown by a signature on the volunteer consent form,
Registered with the French Social Security in agreement with the French law on biomedical experimentation

Who cannot join

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; had a history of relevant atopy,
Had a significant infection or known inflammatory process at screening or admission to the treatment period; acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to the treatment period,
Were vegetarians, vegans or had medical dietary restrictions,
Could not communicate reliably with the Investigator,
Were unlikely to co-operate with the requirements of the study; history of hypersensitivity to OPC, tolcapone, ENT, levodopa, carbidopa, benserazide or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs,
Had any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, dermatological, hematological, neurological, or psychiatric disease,

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Presented 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,
Had taken any prescribed or over the counter drug (including antacid drug), with the exception of paracetamol (up to 3 g per day) within 2 weeks prior to the dose administration,
Consumed 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,
Drank more than 8 cups daily of beverage containing caffeine,
Had 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,
Had received any experimental drug within the exclusion period defined in the National Register for Healthy Volunteers of the French Ministry of Health,
Forfeited their freedom by administrative or legal award or were under guardianship,
Had undergone surgery or had donated blood (i.e. 450 mL) within 12 weeks before study Day 1,
Had positive urine screening of ethyl alcohol or drugs of abuse upon admission to the treatment period,
Had any history of tuberculosis and/or prophylaxis for tuberculosis; positive results to HIV, HBsAg or anti-HCV tests; participation in any previous clinical study with OPC,
If female, was pregnant or breast-feeding.

Trial locations and contacts

1 site in 1 country.

France1 site

SGS aster
Paris, 75015

Other trials in France

About this study

Official title: The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics When Administered With Immediate-release 100/25 mg Levodopa/Carbidopa in Healthy Subjects

Read the detailed description

This study was a single-centre, randomized, double-blind, gender-balanced, placebo-controlled study in 4 groups of 20 healthy subjects each (10 male and 10 female). The clinical part included a screening examination within 3 weeks before the first institutionalization, an ambulatory period of 11 days (from Day 1 evening to Day 11 evening), during which the subjects returned to the clinical unit every evening, followed by an institutionalization of 1.5 days (from Day 11 evening to Day 13 morning (i.e. 14 h after the third administration of levodopa/carbidopa). Then, a follow-up visit at 5 to 9 days after collection of the last PK blood sample (i.e. Day 13). The maximum total duration of the clinical study, including the 21-day screening period and the post-study follow-up, was expected to be about 39 to 43 days.

Conditions: Parkinson's Disease (PD)
Being tested: BIA 9-1067, Entacapone, Placebo, Levodopa/carbidopa
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 9-1067Drug
Also called Opicapone, OPC
BIA 9-1067 25 mg and 50 mg
EntacaponeDrug
Also called Comtan®, ENT
Entacapone (ENT), over-encapsulated tablet 200 mg
PlaceboDrug
Also called PLC, placebo
PLC, placebo
Levodopa/carbidopaDrug
Also called Sinemet®
Levodopa/carbidopa, tablet 100/25 mg

Study groups in NCT02170376
Study group	Role	What they receive
Group 1	Experimental	Placebo once-daily for 11 days 200 mg entacapone concomitantly with levodopa/carbidopa on Day 12 Receives: Drug: Entacapone; Drug: Placebo; Drug: Levodopa/carbidopa
Group 2	Experimental	25 mg BIA 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12 Receives: Drug: BIA 9-1067; Drug: Placebo; Drug: Levodopa/carbidopa
Group 3	Experimental	50 mg 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12 Receives: Drug: BIA 9-1067; Drug: Placebo; Drug: Levodopa/carbidopa
Group 4	Experimental	75 mg 9-1067 once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12 Receives: Drug: BIA 9-1067; Drug: Placebo; Drug: Levodopa/carbidopa
Group 5	Placebo comparator	placebo once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12 Receives: Drug: Placebo; Drug: Levodopa/carbidopa

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax - Maximum Plasma Concentration of Levodopa
Cmax - Maximum plasma concentration of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.
Measured: pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration
Tmax - Time of Occurrence of Maximum Plasma Concentration
Tmax - Time to Reach maximum plasma concentration of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone
Measured: pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration
AUC0-∞ - Area Under the Concentration-time Curve From Time Zero up to Infinity With Extrapolation of the Terminal Phase
AUC0-∞ of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.
Measured: pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration
AUC0-t - Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Time (t) Corresponding to the Last Quantifiable Concentration.
AUC0-t - of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.
Measured: pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration
AUC0-5 - AUC Over 5 Hours
AUC0-5 - of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.
Measured: pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration
t1/2 - Terminal Plasma Half-life
t1/2 - Terminal plasma half-life of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.
Measured: pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2011Jan 2012

First posted23 Jun 2014 (estimated)
Study startSep 2011
Primary completionJan 2012
Study completionJan 2012

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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02170376
Sponsor's protocol ID: BIA-91067-124
Status last verified: Jul 2016
First submitted: 19 Jun 2014
Last updated: 20 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics When Administered With Immediate-release 100/25 mg Levodopa/Carbidopa in Healthy Subjects
ClinicalTrials.gov ID: NCT02170376
Acronym / sponsor ID: BIA-91067-124
Conditions: Parkinson's Disease (PD)
Keywords: Parkinson's disease (PD), BIA 9-1067, Opicapone
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Bial - Portela C S.A.Industry (pharma, biotech, devices)
Study start: Sep 2011
Primary completion: Jan 2012 (actual)
Study completion: Jan 2012 (actual)
First posted: 23 Jun 2014 (estimated)
Results: Posted 20 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Group 1	Experimental	Drug: Entacapone, Drug: Placebo, Drug: Levodopa/carbidopaPlacebo once-daily for 11 days 200 mg entacapone concomitantly with levodopa/carbidopa on Day 12
Group 2	Experimental	Drug: BIA 9-1067, Drug: Placebo, Drug: Levodopa/carbidopa25 mg BIA 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12
Group 3	Experimental	Drug: BIA 9-1067, Drug: Placebo, Drug: Levodopa/carbidopa50 mg 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12
Group 4	Experimental	Drug: BIA 9-1067, Drug: Placebo, Drug: Levodopa/carbidopa75 mg 9-1067 once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12
Group 5	Placebo comparator	Drug: Placebo, Drug: Levodopa/carbidopaplacebo once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Healthy male and female volunteers 18 to 45 years old (inclusive),
Body Mass Index (BMI) in normal range (18-30 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 ECG (electrocardiogram),
Negative tests for Hepatitis B surface antigen (HBsAG), anti-Hepatitis C virus (HCV) antibodies and Human immunodeficiency virus (HIV) -1 and HIV-2 antibodies at screening,
Negative screen for drugs of abuse and alcohol at screening and admission to the treatment period,

Key exclusion criteria (17 listed)

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; had a history of relevant atopy,
Had a significant infection or known inflammatory process at screening or admission to the treatment period; acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to the treatment period,
Were vegetarians, vegans or had medical dietary restrictions,
Could not communicate reliably with the Investigator,
Were unlikely to co-operate with the requirements of the study; history of hypersensitivity to OPC, tolcapone, ENT, 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 9-1067Also: Opicapone, OPCBIA 9-1067 25 mg and 50 mg	Drug	Group 2, Group 3, Group 4
EntacaponeAlso: Comtan®, ENTEntacapone (ENT), over-encapsulated tablet 200 mg	Drug	Group 1
PlaceboAlso: PLC, placeboPLC, placebo	Drug	Group 1, Group 2, Group 3, Group 4, Group 5
Levodopa/carbidopaAlso: Sinemet®Levodopa/carbidopa, tablet 100/25 mg	Drug	Group 1, Group 2, Group 3, Group 4, Group 5

Primary outcome

Cmax - Maximum Plasma Concentration of Levodopa
Time frame: pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration
Cmax - Maximum plasma concentration of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.
Tmax - Time of Occurrence of Maximum Plasma Concentration
Time frame: pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration
Tmax - Time to Reach maximum plasma concentration of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone
AUC0-∞ - Area Under the Concentration-time Curve From Time Zero up to Infinity With Extrapolation of the Terminal Phase
Time frame: pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration
AUC0-∞ of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.
AUC0-t - Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Time (t) Corresponding to the Last Quantifiable Concentration.
Time frame: pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration
AUC0-t - of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.
AUC0-5 - AUC Over 5 Hours
Time frame: pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration
AUC0-5 - of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.
t1/2 - Terminal Plasma Half-life
Time frame: pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration
t1/2 - Terminal plasma half-life of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.

Results and safety

Results posted to the registry on 20 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: Placebo Then Entacapone/Levodopa	16	16
Group 2: BIA 25 mg Then Placebo/Levodopa/Carbidopa	16	15
Group 3: BIA 50 mg Then Placebo/Levodopa/Carbidopa	16	16
Group 4: BIA 75 mg Then Placebo/Levodopa/Carbidopa	16	16
Group 5: Placebo Then Levodopa/Carbidopa	16	16

Primary outcome: Cmax - Maximum Plasma Concentration of Levodopa

Time frame: pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration. Mean (Standard Deviation). Unit: ng/mL

Measure	Placebo n = 16	OPC 25 mg n = 15	OPC 50 mg n = 16	OPC 75 mg n = 16	ENT 200 mg n = 16
Post First Dose	1047 (340)	1203 (453)	1030 (400)	1057 (335)	876 (328)
Post Second Dose	1550 (542)	1619 (762)	1974 (847)	2113 (868)	1437 (569)
Post Third Dose	1268 (532)	1393 (627)	1346 (337)	1658 (435)	1303 (518)

Primary outcome: Tmax - Time of Occurrence of Maximum Plasma Concentration

Measure	Placebo n = 16	OPC 25 mg n = 15	OPC 50 mg n = 16	OPC 75 mg n = 16	ENT 200 mg n = 16
Post First Dose	1.31 (0.854)	1.13 (0.790)	1.34 (1.01)	1.28 (0.515)	1.13 (0.695)
Post Second Dose	0.875 (0.465)	1.20 (0.862)	1.06 (0.892)	1.19 (0.854)	0.906 (0.491)
Post Third Dose	1.69 (0.964)	1.33 (0.699)	1.34 (0.65)	1.31 (0.854)	1.59 (0.861)

Primary outcome: AUC0-∞ - Area Under the Concentration-time Curve From Time Zero up to Infinity With Extrapolation of the Terminal Phase

Measure	Placebo n = 16	OPC 25 mg n = 15	OPC 50 mg n = 16	OPC 75 mg n = 16	ENT 200 mg n = 16
Post First Dose	2305 (391)	3732 (1418)	3363 (1042)	3998 (1275)	2752 (540)
Post Second Dose	3070 (396)	4967 (2003)	5727 (1495)	6213 (1440)	4367 (1463)
Post Third Dose	3299 (433)	5614 (2467)	5912 (1478)	7177 (1835)	4707 (363)

Primary outcome: AUC0-t - Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Time (t) Corresponding to the Last Quantifiable Concentration.

Measure	Placebo n = 16	OPC 25 mg n = 15	OPC 50 mg n = 16	OPC 75 mg n = 16	ENT 200 mg n = 16
Post First Dose	1985 (346)	2665 (867)	2383 (699)	2829 (794)	2041 (671)
Post Second Dose	2774 (353)	3678 (1455)	4151 (1070)	4597 (1041)	3445 (1128)
Post Third Dose	3123 (447)	5391 (2444)	5685 (1466)	6928 (1797)	4366 (1426)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	0 of 16 (0%)	9 of 16 (56.3%)	Not reported
Group 2	0 of 16 (0%)	5 of 16 (31.3%)	Not reported
Group 3	0 of 16 (0%)	8 of 16 (50%)	Not reported
Group 4	0 of 16 (0%)	8 of 16 (50%)	Not reported
Group 5	0 of 16 (0%)	11 of 16 (68.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
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, Entacapone and Levodopa/carbidopa 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 11 inclusion and 17 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 20 Sep 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 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 20 Sep 2016). 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 (time frame: pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02170376.

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 20 Sep 2016.