CompletedNCT01520727Updated Jan 8, 2015Results posted

A Single Oral Ascending Dose Study of BIA 9-1067 in Healthy Male Subjects

A Phase 1 interventional study of BIA 9-1067 and Placebo in Parkinson Disease, sponsored by Bial - Portela C S.A.. Completed at 1 site in France. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-08.

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

Phase: Phase 1
Study type: Interventional
Enrollment: 64
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: Male

Study summary

The purpose of this study was to investigate the safety, tolerability, pharmacokinetics and catechol-O-methyltransferase (COMT) activity of BIA 9-1067 in healthy male subjects after single oral ascending doses.

Read the detailed description

Single centre, randomised, double-blind, placebo-controlled study of single ascending doses in up to 8 sequential groups of 8 healthy young male subjects.

Conditions studied

Parkinson Disease

Browse trials for

Parkinson Disease 4,487

Keywords

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 64 is above 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

A signed and dated informed consent form before any study-specific screening procedure was performed.
Aged between 18 and 45 years, inclusive.
Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead ECG.
Non-smoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

Exclusion criteria

Exclusion Criteria:

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.
Acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study day 1.
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
Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA [3,4-methylenedioxy-methamphetamine; ecstasy]).
History of any clinically important drug allergy.
Prohibited Treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product (IMP) administration.
Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 hours before study day 1.
Use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen [paracetamol], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before IMP administration.
Donation of blood (i.e. 450 mL) within 60 days before study day 1

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial assignment
Masking: Double (Participant, Investigator)
Enrollment: 64 participants (actual)

Study arms

Experimental
BIA 9-1067 10 mg
BIA 9-1067 (Opicapone, OPC) - 10 mg
Drug: BIA 9-1067
Experimental
BIA 9-1067 25 mg
BIA 9-1067 (Opicapone, OPC) - 25 mg
Drug: BIA 9-1067
Experimental
BIA 9-1067 50 mg
BIA 9-1067 (Opicapone, OPC) - 50 mg
Drug: BIA 9-1067
Experimental
BIA 9-1067 100 mg
BIA 9-1067 (Opicapone, OPC) - 100 mg
Drug: BIA 9-1067
Experimental
BIA 9-1067 200 mg
BIA 9-1067 (Opicapone, OPC) - 200 mg
Drug: BIA 9-1067
Experimental
BIA 9-1067 400 mg
BIA 9-1067 (Opicapone, OPC) - 400 mg
Drug: BIA 9-1067
Experimental
BIA 9-1067 800 mg
BIA 9-1067 (Opicapone, OPC) - 800 mg
Drug: BIA 9-1067
Experimental
BIA 9-1067 1200 mg
BIA 9-1067 (Opicapone, OPC) - 1200 mg
Drug: BIA 9-1067
Placebo comparator
Placebo
Placebo (PLC): single-dose
Drug: Placebo

Interventions

DrugBIA 9-1067
single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
Also known as: Entacapone
DrugPlacebo
single-dose

What researchers measure

Primary outcomes

Adverse Events (AEs)
Safety was evaluated from the number of reported adverse events (AEs)
Time frame: 7 weeks

Secondary outcomes

Cmax - BIA 9-1067
Cmax - maximum plasma concentration
Time frame: pre-dose then post-dose. Hour 0.25, 0.5, 0,75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 , 60 and 72 hours post dose
Time to Cmax (Tmax)
Time frame: pre-dose then post-dose. Hour 0.25, 0.5, 0,75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 , 60 and 72 hours post dose

Results

Posted Jan 8, 2015

Participant flow

Participant flow — Overall Study
Milestone	BIA 9-1067 10 mg	BIA 9-1067 25 mg	BIA 9-1067 50 mg	BIA 9-1067 100 mg	BIA 9-1067 200 mg	BIA 9-1067 400 mg	BIA 9-1067 800 mg	BIA 9-1067 1200 mg	Placebo
Started	6	6	6	6	6	6	6	6	16
Completed	6	6	6	6	6	6	6	6	16
Not completed	0	0	0	0	0	0	0	0	0

Outcome measures

PrimaryAdverse Events (AEs)

Safety was evaluated from the number of reported adverse events (AEs)

Time frame:: 7 weeks
Reported as:: Number · Number of Adverse Events

Adverse Events (AEs)
Number of Adverse Events	BIA 9-1067 10 mg	BIA 9-1067 25 mg	BIA 9-1067 50 mg	BIA 9-1067 100 mg	BIA 9-1067 200 mg	BIA 9-1067 400 mg	BIA 9-1067 800 mg	BIA 9-1067 1200 mg	Placebo
Adverse Events (AEs)	0	0	2	0	1	1	0	1	4

SecondaryCmax - BIA 9-1067

Cmax - maximum plasma concentration

Time frame:: pre-dose then post-dose. Hour 0.25, 0.5, 0,75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 , 60 and 72 hours post dose
Reported as:: Mean · ng/mL

Cmax - BIA 9-1067
ng/mL	BIA 9-1067 10 mg	BIA 9-1067 25 mg	BIA 9-1067 50 mg	BIA 9-1067 100 mg	BIA 9-1067 200 mg	BIA 9-1067 400 mg	BIA 9-1067 800 mg	BIA 9-1067 1200 mg
Cmax - BIA 9-1067	130.7 ± 68.0	308.5 ± 128.1	522.2 ± 186.7	927.2 ± 378.9	1287.5 ± 585.6	2013.3 ± 608.7	2786.7 ± 1335.9	4883.3 ± 1501.5

SecondaryTime to Cmax (Tmax)

Time frame:: pre-dose then post-dose. Hour 0.25, 0.5, 0,75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 , 60 and 72 hours post dose
Reported as:: Median · hours

Time to Cmax (Tmax)
hours	BIA 9-1067 10 mg	BIA 9-1067 25 mg	BIA 9-1067 50 mg	BIA 9-1067 100 mg	BIA 9-1067 200 mg	BIA 9-1067 400 mg	BIA 9-1067 800 mg	BIA 9-1067 1200 mg
Time to Cmax (Tmax)	2.5 (2.0 to 4.0)	1.5 (1.0 to 4.0)	3.5 (1.5 to 4.0)	1.8 (1.0 to 3.0)	2.0 (1.0 to 3.0)	2.0 (1.5 to 5.0)	2.5 (0.8 to 5.3)	1.5 (1.0 to 3.0)

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
BIA 9-1067 10 mg	—	0/6 (0%)	0/6 (0%)
BIA 9-1067 25 mg	—	0/6 (0%)	0/6 (0%)
BIA 9-1067 50 mg	—	0/6 (0%)	2/6 (33.3%)
BIA 9-1067 100 mg	—	0/6 (0%)	0/6 (0%)
BIA 9-1067 200 mg	—	0/6 (0%)	1/6 (16.7%)
BIA 9-1067 400 mg	—	0/6 (0%)	1/6 (16.7%)
BIA 9-1067 800 mg	—	0/6 (0%)	0/6 (0%)
BIA 9-1067 1200 mg	—	0/6 (0%)	1/6 (16.7%)
Placebo	—	1/16 (6.3%)	2/16 (12.5%)

Most frequent serious events

Most frequent serious events
Event	BIA 9-1067 10 mg	BIA 9-1067 25 mg	BIA 9-1067 50 mg	BIA 9-1067 100 mg	BIA 9-1067 200 mg	BIA 9-1067 400 mg	BIA 9-1067 800 mg	BIA 9-1067 1200 mg	Placebo
Spastic ParaplegiaNervous system disorders	0/6	0/6	0/6	0/6	0/6	0/6	0/6	0/6	1/16

Most frequent other events

Most frequent other events
Event	BIA 9-1067 10 mg	BIA 9-1067 25 mg	BIA 9-1067 50 mg	BIA 9-1067 100 mg	BIA 9-1067 200 mg	BIA 9-1067 400 mg	BIA 9-1067 800 mg	BIA 9-1067 1200 mg	Placebo
Syncope VasovagalNervous system disorders	0/6	0/6	1/6	0/6	0/6	0/6	0/6	0/6	0/16
NasopharyngitisInfections and infestations	0/6	0/6	1/6	0/6	0/6	0/6	0/6	0/6	0/16
HeadacheNervous system disorders	0/6	0/6	0/6	0/6	1/6	0/6	0/6	1/6	0/16
EpistaxisRespiratory, thoracic and mediastinal disorders	0/6	0/6	0/6	0/6	0/6	1/6	0/6	0/6	0/16
GastroenteritisGastrointestinal disorders	0/6	0/6	0/6	0/6	0/6	0/6	0/6	0/6	1/16
Orthostatic HypotensionVascular disorders	0/6	0/6	0/6	0/6	0/6	0/6	0/6	0/6	1/16

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	BIA 9-1067 10 mg	BIA 9-1067 25 mg	BIA 9-1067 50 mg	BIA 9-1067 100 mg	BIA 9-1067 200 mg	BIA 9-1067 400 mg	BIA 9-1067 800 mg	BIA 9-1067 1200 mg	Placebo	Total
<=18 years	0	0	0	0	0	0	0	0	0	0
Between 18 and 65 years	6	6	6	6	6	6	6	6	16	64
>=65 years	0	0	0	0	0	0	0	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	BIA 9-1067 10 mg	BIA 9-1067 25 mg	BIA 9-1067 50 mg	BIA 9-1067 100 mg	BIA 9-1067 200 mg	BIA 9-1067 400 mg	BIA 9-1067 800 mg	BIA 9-1067 1200 mg	Placebo	Total
Female	0	0	0	0	0	0	0	0	0	0
Male	6	6	6	6	6	6	6	6	16	64

Study locations

1 site

BIOTRIAL
Rennes, F-35000, France

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01520727
Lead sponsor: Bial - Portela C S.A.
Responsible party: Sponsor
First posted: Jan 30, 2012
Start date: Oct 2007
Primary completion: Dec 2007
Completion: Apr 2009
Results posted: Jan 8, 2015
Last update: Jan 8, 2015

Study contacts

Nicolas Fauchoux, MD

principal investigator · Biotrial

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Parkinson Disease→

Other studies from this sponsor

Bial - Portela C S.A.

Start the discussion