Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 9-1067

NCT02071810 | Completed Phase 1 Results

• 1 other identifier: BIA-91067-102
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the tolerability of BIA 9-1067 after multiple rising dose regimens of BIA 9-1067.

Conditions

Parkinson's Disease (PD)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Patients With at Least One Adverse Event

  participants will be followed for the duration of hospital stay, an expected average of 6 weeks

Study Arms (5)

BIA 9-1067 5 mg

EXPERIMENTAL

BIA 9-1067 (OPC, Opicapone) 5 mg

Drug: BIA 9-1067

BIA 9-1067 10 mg

EXPERIMENTAL

BIA 9-1067 (OPC, Opicapone) 10 mg

Drug: BIA 9-1067

BIA 9-1067 20 mg

EXPERIMENTAL

BIA 9-1067 (OPC, Opicapone) 20 mg

Drug: BIA 9-1067

BIA 9-1067 30 mg

EXPERIMENTAL

BIA 9-1067 (OPC, Opicapone) 30 mg

Drug: BIA 9-1067

Placebo

EXPERIMENTAL

Placebo, PLC

Drug: Placebo

Interventions

BIA 9-1067 DRUG

Also known as: OPC, Opicapone

BIA 9-1067 10 mg; BIA 9-1067 20 mg; BIA 9-1067 30 mg; BIA 9-1067 5 mg

Placebo DRUG

Also known as: PLC, Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A signed and dated informed consent form before any study-specific screening procedure is 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 electrocardiogram (ECG).
• Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

You may not qualify if:

• 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
• Have previously received BIA 9-1067.
• 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 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 (ie 450 ml) within 90 days before study day 1.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

BIOTRIAL

Rueil, Malmaison, F-92501, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

opicapone

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Head of Clinical Research
• Organization: Bial - Portela & Cª, S.A.

jose.rocha@bial.com

+351 229 866 100

Study Officials

• Dikran Mouradian, MD

  Biotrial

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2012
• First Posted: February 26, 2014
• Study Start: April 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: December 24, 2015
• Results First Posted: January 9, 2015

Record last verified: 2015-11

Locations

FR (1)