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

Phase 1

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: BIA 9-1067; Drug: Placebo

• Registration Number: NCT01520727
• Lead Sponsor: Bial - Portela C S.A.

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.

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2007-12
• Study Completion: 2009-04
• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-26
• Study First Posted: 2012-01-30
• Status Verified: 2014-12
• Results First Submitted: 2014-12-29
• Results First Submitted QC: 2014-12-29
• Last Update Submitted: 2014-12-29
• Results First Posted: 2015-01-08
• Last Update Posted: 2015-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
BIA 9-1067 25 mg	BIA 9-1067	BIA 9-1067 (Opicapone, OPC) - 25 mg
BIA 9-1067 1200 mg	BIA 9-1067	BIA 9-1067 (Opicapone, OPC) - 1200 mg
BIA 9-1067 200 mg	BIA 9-1067	BIA 9-1067 (Opicapone, OPC) - 200 mg
Placebo	Placebo	Placebo (PLC): single-dose
BIA 9-1067 50 mg	BIA 9-1067	BIA 9-1067 (Opicapone, OPC) - 50 mg
BIA 9-1067 100 mg	BIA 9-1067	BIA 9-1067 (Opicapone, OPC) - 100 mg
BIA 9-1067 400 mg	BIA 9-1067	BIA 9-1067 (Opicapone, OPC) - 400 mg
BIA 9-1067 800 mg	BIA 9-1067	BIA 9-1067 (Opicapone, OPC) - 800 mg
BIA 9-1067 10 mg	BIA 9-1067	BIA 9-1067 (Opicapone, OPC) - 10 mg

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Cmax - BIA 9-1067	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	Cmax - maximum plasma concentration
Time to Cmax (Tmax)	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

Trial Locations

Locations (1)

BIOTRIAL; 🇫🇷 Rennes, France