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

NCT ID: NCT01520727

Last Updated: 2015-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2009-04-30

Brief 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.

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

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BIA 9-1067 10 mg

BIA 9-1067 (Opicapone, OPC) - 10 mg

Group Type: EXPERIMENTAL

BIA 9-1067

Intervention Type: DRUG

single ascending doses in up to 8 sequential groups of 8 healthy young male subjects

BIA 9-1067 25 mg

BIA 9-1067 (Opicapone, OPC) - 25 mg

Group Type: EXPERIMENTAL

BIA 9-1067

Intervention Type: DRUG

single ascending doses in up to 8 sequential groups of 8 healthy young male subjects

BIA 9-1067 50 mg

BIA 9-1067 (Opicapone, OPC) - 50 mg

Group Type: EXPERIMENTAL

BIA 9-1067

Intervention Type: DRUG

single ascending doses in up to 8 sequential groups of 8 healthy young male subjects

BIA 9-1067 100 mg

BIA 9-1067 (Opicapone, OPC) - 100 mg

Group Type: EXPERIMENTAL

BIA 9-1067

Intervention Type: DRUG

single ascending doses in up to 8 sequential groups of 8 healthy young male subjects

BIA 9-1067 200 mg

BIA 9-1067 (Opicapone, OPC) - 200 mg

Group Type: EXPERIMENTAL

BIA 9-1067

Intervention Type: DRUG

single ascending doses in up to 8 sequential groups of 8 healthy young male subjects

BIA 9-1067 400 mg

BIA 9-1067 (Opicapone, OPC) - 400 mg

Group Type: EXPERIMENTAL

BIA 9-1067

Intervention Type: DRUG

single ascending doses in up to 8 sequential groups of 8 healthy young male subjects

BIA 9-1067 800 mg

BIA 9-1067 (Opicapone, OPC) - 800 mg

Group Type: EXPERIMENTAL

BIA 9-1067

Intervention Type: DRUG

single ascending doses in up to 8 sequential groups of 8 healthy young male subjects

BIA 9-1067 1200 mg

BIA 9-1067 (Opicapone, OPC) - 1200 mg

Group Type: EXPERIMENTAL

BIA 9-1067

Intervention Type: DRUG

single ascending doses in up to 8 sequential groups of 8 healthy young male subjects

Placebo

Placebo (PLC): single-dose

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

single-dose

Interventions

BIA 9-1067

single ascending doses in up to 8 sequential groups of 8 healthy young male subjects

Intervention Type: DRUG

Placebo

single-dose

Intervention Type: DRUG

Other Intervention Names

Entacapone

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bial - Portela C S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas Fauchoux, MD

Role: PRINCIPAL_INVESTIGATOR

Biotrial

Locations

BIOTRIAL

Rennes, , France

Countries

France

Other Identifiers

BIA-91067-101

Identifier Type: -

Identifier Source: org_study_id