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

BIAL

Status and phase: Completed; Phase 1

Conditions: Parkinson Disease

Treatments: Drug: Placebo; Drug: BIA 9-1067

Study type: Interventional

Funder types: Industry

Identifiers

NCT01520727

BIA-91067-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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64 participants in 9 patient groups, including a placebo group

BIA 9-1067 10 mg

Experimental group

Description:

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

Treatment:

Drug: BIA 9-1067

BIA 9-1067 25 mg

Experimental group

Description:

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

Treatment:

Drug: BIA 9-1067

BIA 9-1067 50 mg

Experimental group

Description:

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

Treatment:

Drug: BIA 9-1067

BIA 9-1067 100 mg

Experimental group

Description:

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

Treatment:

Drug: BIA 9-1067

BIA 9-1067 200 mg

Experimental group

Description:

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

Treatment:

Drug: BIA 9-1067

BIA 9-1067 400 mg

Experimental group

Description:

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

Treatment:

Drug: BIA 9-1067

BIA 9-1067 800 mg

Experimental group

Description:

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

Treatment:

Drug: BIA 9-1067

BIA 9-1067 1200 mg

Experimental group

Description:

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

Treatment:

Drug: BIA 9-1067

Placebo

Placebo Comparator group

Description:

Placebo (PLC): single-dose

Treatment:

Drug: Placebo