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

NCT01520727 | Completed Phase 1 Results

• 1 other identifier: BIA-91067-101
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

BIA 9-1067

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AEs)

  Safety was evaluated from the number of reported adverse events (AEs)

  7 weeks

Secondary Outcomes (2)

• 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

• 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

Study Arms (9)

BIA 9-1067 10 mg

EXPERIMENTAL

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

Drug: BIA 9-1067

BIA 9-1067 25 mg

EXPERIMENTAL

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

Drug: BIA 9-1067

BIA 9-1067 50 mg

EXPERIMENTAL

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

Drug: BIA 9-1067

BIA 9-1067 100 mg

EXPERIMENTAL

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

Drug: BIA 9-1067

BIA 9-1067 200 mg

EXPERIMENTAL

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

Drug: BIA 9-1067

BIA 9-1067 400 mg

EXPERIMENTAL

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

Drug: BIA 9-1067

BIA 9-1067 800 mg

EXPERIMENTAL

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

Drug: BIA 9-1067

BIA 9-1067 1200 mg

EXPERIMENTAL

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

Drug: BIA 9-1067

Placebo

PLACEBO COMPARATOR

Placebo (PLC): single-dose

Drug: Placebo

Interventions

BIA 9-1067 DRUG

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

Also known as: Entacapone

BIA 9-1067 10 mg; BIA 9-1067 100 mg; BIA 9-1067 1200 mg; BIA 9-1067 200 mg; BIA 9-1067 25 mg; BIA 9-1067 400 mg; BIA 9-1067 50 mg; BIA 9-1067 800 mg

Placebo DRUG

single-dose

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 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.

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
• 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

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

BIOTRIAL

Rennes, F-35000, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

opicapone; entacapone

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

• Nicolas Fauchoux, 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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2012
• First Posted: January 30, 2012
• Study Start: October 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: April 1, 2009
• Last Updated: January 8, 2015
• Results First Posted: January 8, 2015

Record last verified: 2014-12

Locations

FR (1)