Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 9-1067

NCT ID: NCT02071810

Last Updated: 2015-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2008-09-30

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.

Detailed Description

Single centre, double-blind, randomised, placebo-controlled study of four dosage regimens of BIA 9-1067 in four groups of healthy male volunteers. In each group, the study will consist of an once-daily (o.d.) 8-day multiple-dose period. Progression to the next dose level will only occur if the previous dose level was considered to be safe and well tolerated. An appropriate interval (will separate the investigation of doses to permit a timely review and evaluation of safety data prior to proceeding to a higher dose level.

Conditions

Parkinson's Disease (PD)

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

BIA 9-1067 5 mg

BIA 9-1067 (OPC, Opicapone) 5 mg

Group Type: EXPERIMENTAL

BIA 9-1067

Intervention Type: DRUG

BIA 9-1067 10 mg

BIA 9-1067 (OPC, Opicapone) 10 mg

Group Type: EXPERIMENTAL

BIA 9-1067

Intervention Type: DRUG

BIA 9-1067 20 mg

BIA 9-1067 (OPC, Opicapone) 20 mg

Group Type: EXPERIMENTAL

BIA 9-1067

Intervention Type: DRUG

BIA 9-1067 30 mg

BIA 9-1067 (OPC, Opicapone) 30 mg

Group Type: EXPERIMENTAL

BIA 9-1067

Intervention Type: DRUG

Placebo

Placebo, PLC

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Interventions

BIA 9-1067

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

OPC, Opicapone; PLC, Placebo

Eligibility Criteria

Inclusion Criteria

1. A signed and dated informed consent form before any study-specific screening procedure is performed.

2. Aged between 18 and 45 years, inclusive.

3. 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).

4. 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.

Exclusion Criteria

1. 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.

2. Acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study day 1.

3. History of drug abuse within 1 year before study day 1.

4. 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

5. Have previously received BIA 9-1067.

6. Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.

7. Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA [3,4-methylenedioxy-methamphetamine; ecstasy]).

8. History of any clinically important drug allergy.

9. Prohibited Treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product (IMP) administration.

10. 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.

11. 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.

12. Donation of blood (ie 450 ml) within 90 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

Dikran Mouradian, MD

Role: PRINCIPAL_INVESTIGATOR

Biotrial

Locations

BIOTRIAL

Rueil, Malmaison, France

Countries

France

Other Identifiers

BIA-91067-102

Identifier Type: -

Identifier Source: org_study_id