CompletedNCT02169466Updated Nov 3, 2015Results posted

Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide

A Phase 1 interventional study of BIA 9-1067 and Placebo in Parkinson's Disease (PD), sponsored by Bial - Portela C S.A.. Completed at 1 site in Portugal. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-03.

Sponsored by Bial - Portela C S.A. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 22
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: Male

Study summary

To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of controlled-release levodopa 100 mg/benserazide 25 mg (Madopar HBS).

Read the detailed description

Single centre, double-blind, randomized, placebo-controlled, crossover study with four consecutive single-dose treatment periods. The washout period between doses was to be at least10 days. On each treatment period (25, 50 and 100 mg BIA 9-1067 or placebo), after completion of pre-dose assessments, BIA 9-1067-Placebo was to be administered concomitantly with the dose of Madopar HBS; post-dose assessments were to be completed and subjects were to be discharged 72 h post-dose.

Conditions studied

Parkinson's Disease (PD)

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Parkinson Disease 4,487

Keywords

Parkinson's disease (PD)
Opicapone
BIA 9-1067

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 22 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Bial - Portela C S.A. is the lead sponsor of 133 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

Inclusion criteria

Male subjects between 18 and 45 years, inclusive.
Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.
Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
Subjects who had clinical laboratory test results that were clinically acceptable at screening and admission to first treatment period.
Subjects who had negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibodies (HCV Ab), and Human immunodeficiency viruses -1 and -2 antibodies (HIV-1 and HIV-2 Ab) at screening.
Subjects who had/were negative for drugs of abuse at screening and admission to each treatment period.
Subjects who were non-smokers or who smoked ≤10 cigarettes or equivalent per day.
Subjects who were able and willing to give written informed consent.

Exclusion criteria

Exclusion Criteria:

Subjects who did not conform to the above inclusion criteria, or
Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, 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.
Subjects who had a history of glaucoma.
Subjects who had a history of alcoholism or drug abuse.
Subjects who consumed more than 21 units of alcohol a week.
Subjects who had a significant infection or known inflammatory process on screening or first admission.
Subjects who had acute gastrointestinal symptoms at the time of screening or first admission (e.g., nausea, vomiting, diarrhoea, heartburn).
Subjects who used medicines within 2 weeks of first admission that, in the opinion of the investigator, may affect the safety or other study assessments.
Subjects who used any investigational drug or participated in any clinical trial within 2 months of their first admission.
Subjects who donated or received any blood or blood products within the previous 2 months prior to screening.
Subjects who were vegetarians, vegans or have 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.
Subjects who were BIAL - Portela \& Cª, SA employees.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 22 participants (actual)

Study arms

Experimental
Group 1
Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)
Drug: BIA 9-1067 · Drug: Placebo · Drug: Madopar® HBS
Experimental
Group 2
Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)
Drug: BIA 9-1067 · Drug: Placebo · Drug: Madopar® HBS
Experimental
Group 3
Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)
Drug: BIA 9-1067 · Drug: Placebo · Drug: Madopar® HBS
Experimental
Group 4
Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)
Drug: BIA 9-1067 · Drug: Placebo · Drug: Madopar® HBS

Interventions

DrugBIA 9-1067
OPC, Opicapone
Also known as: OPC, Opicapone
DrugPlacebo
PLC, Placebo
Also known as: PLC, Placebo
DrugMadopar® HBS
controlled-release levodopa 100 mg/benserazide 25 mg

What researchers measure

Primary outcomes

Cmax - Maximum Observed Plasma Concentration of Levodopa
Primary pharmacokinetic parameter: Levodopa maximum observed plasma concentration (Cmax) (ng/mL)
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
AUC0-t - Area Under the Plasma Concentration-time Curve
Primary pharmacokinetic parameter: Area under the plasma concentration-time curve for levodopa
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
AUC0-∞ - AUC From Time Zero to Infinity
Primary pharmacokinetic parameter: Area under the plasma concentration-time curve from time zero to infinity for levodopa
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
Tmax - Time to Cmax
Primary pharmacokinetic parameter: tmax - time to Cmax
Time frame: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.

Results

Posted Nov 3, 2015

Participant flow

Participant flow — Overall Study
Milestone	BIA 9-1067: 25, 50, 100, Placebo	BIA 9-1067: 50, 100, Placebo, 25	BIA 9-1067: 100, Placebo, 25, 50	BIA 9-1067: Placebo, 25, 50, 100
Started	6	6	5	5
25 mg bia 9-1067	6	5	5	5
50 mg bia 9-1067	6	6	5	5
100 mg bia 9-1067	6	6	5	5
Placebo	5	6	5	5
Completed	5	5	5	5
Not completed	1	1	0	0

Outcome measures

PrimaryCmax - Maximum Observed Plasma Concentration of Levodopa

Primary pharmacokinetic parameter: Levodopa maximum observed plasma concentration (Cmax) (ng/mL)

Time frame:: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
Reported as:: Mean · ng/mL

Cmax - Maximum Observed Plasma Concentration of Levodopa
ng/mL	BIA 9-1067 25 mg	BIA 9-1067 50 mg	BIA 9-1067 100 mg	Placebo
Cmax - Maximum Observed Plasma Concentration of Levodopa	314 ± 110	266 ± 77.5	263 ± 94.9	260 ± 119

PrimaryAUC0-t - Area Under the Plasma Concentration-time Curve

Primary pharmacokinetic parameter: Area under the plasma concentration-time curve for levodopa

Time frame:: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
Reported as:: Mean · ng.h/mL

AUC0-t - Area Under the Plasma Concentration-time Curve
ng.h/mL	BIA 9-1067 25 mg	BIA 9-1067 50 mg	BIA 9-1067 100 mg	Placebo
AUC0-t - Area Under the Plasma Concentration-time Curve	1084 ± 398	1064 ± 365	1140 ± 592	933 ± 422

PrimaryAUC0-∞ - AUC From Time Zero to Infinity

Primary pharmacokinetic parameter: Area under the plasma concentration-time curve from time zero to infinity for levodopa

Time frame:: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
Reported as:: Mean · ng.h/mL

AUC0-∞ - AUC From Time Zero to Infinity
ng.h/mL	BIA 9-1067 25 mg	BIA 9-1067 50 mg	BIA 9-1067 100 mg	Placebo
AUC0-∞ - AUC From Time Zero to Infinity	1190 ± 441	1181 ± 373	1326 ± 604	1086 ± 380

PrimaryTmax - Time to Cmax

Primary pharmacokinetic parameter: tmax - time to Cmax

Time frame:: pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.
Reported as:: Mean · hours

Tmax - Time to Cmax
hours	BIA 9-1067 25 mg	BIA 9-1067 50 mg	BIA 9-1067 100 mg	Placebo
Tmax - Time to Cmax	2.50 (1.0 to 4.0)	2.50 (1.0 to 4.0)	2.00 (1.0 to 6.0)	2.00 (1.0 to 4.0)

Adverse events

Collected over Just before drug administration until 72 h post-dose. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
BIA 9-1067 25 mg	—	0/21 (0%)	2/21 (9.5%)
BIA 9-1067 50 mg	—	0/22 (0%)	4/22 (18.2%)
BIA 9-1067 100 mg	—	0/22 (0%)	3/22 (13.6%)
Placebo	—	0/21 (0%)	2/21 (9.5%)

Most frequent other events

Most frequent other events
Event	BIA 9-1067 25 mg	BIA 9-1067 50 mg	BIA 9-1067 100 mg	Placebo
Blood creatine phosphokinase increasedInvestigations	1/21	2/22	0/22	0/21
Respiratory tract infectionInfections and infestations	1/21	0/22	0/22	0/21
HeadacheNervous system disorders	0/21	0/22	1/22	1/21
DepressionPsychiatric disorders	0/21	0/22	0/22	1/21
NasopharyngitisInfections and infestations	0/21	1/22	0/22	0/21
Oral herpesInfections and infestations	0/21	1/22	0/22	0/21
PharyngitisInfections and infestations	0/21	1/22	0/22	0/21
RhinorrheaRespiratory, thoracic and mediastinal disorders	0/21	0/22	1/22	0/21
RashSkin and subcutaneous tissue disorders	0/21	0/22	1/22	0/21

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	BIA 9-1067: 25, 50, 100, Placebo	BIA 9-1067: 50, 100, Placebo, 25	BIA 9-1067: 100, Placebo, 25, 50	BIA 9-1067: Placebo, 25, 50, 100	Total
<=18 years	0	0	0	0	0
Between 18 and 65 years	6	6	5	5	22
>=65 years	0	0	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	BIA 9-1067: 25, 50, 100, Placebo	BIA 9-1067: 50, 100, Placebo, 25	BIA 9-1067: 100, Placebo, 25, 50	BIA 9-1067: Placebo, 25, 50, 100	Total
Female	0	0	0	0	0
Male	6	6	5	5	22

Study locations

1 site

BIAL - Portela & Cª - Human Pharmacology Unit (UFH)
S. Mamede do Coronado, Trofa 4745-457, Portugal

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02169466
Lead sponsor: Bial - Portela C S.A.
Responsible party: Sponsor
First posted: Jun 23, 2014
Start date: Jan 2009
Primary completion: May 2009
Completion: May 2009
Results posted: Nov 3, 2015
Last update: Nov 3, 2015

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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