NCT01520727CompletedPhase 1
A Single Oral Ascending Dose Study to Investigate the Safety, Pharmacokinetics and Catechol-O-methyltransferase (COMT) Inhibition Profiles of BIA 9-1067 in Healthy Male Subjects
Bial - Portela C S.A.1 site in 1 country64 target enrollmentStarted: October 2007Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Adverse Events (AEs)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
- •History of drug abuse within 1 year before study day
- •History of alcoholism within 1 year before day
- •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
- •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
Arms & Interventions
BIA 9-1067 1200 mg
Experimental
BIA 9-1067 (Opicapone, OPC) - 1200 mg
Intervention: BIA 9-1067 (Drug)
Placebo
Placebo Comparator
Placebo (PLC): single-dose
Intervention: Placebo (Drug)
BIA 9-1067 10 mg
Experimental
BIA 9-1067 (Opicapone, OPC) - 10 mg
Intervention: BIA 9-1067 (Drug)
BIA 9-1067 25 mg
Experimental
BIA 9-1067 (Opicapone, OPC) - 25 mg
Intervention: BIA 9-1067 (Drug)
BIA 9-1067 50 mg
Experimental
BIA 9-1067 (Opicapone, OPC) - 50 mg
Intervention: BIA 9-1067 (Drug)
BIA 9-1067 100 mg
Experimental
BIA 9-1067 (Opicapone, OPC) - 100 mg
Intervention: BIA 9-1067 (Drug)
BIA 9-1067 200 mg
Experimental
BIA 9-1067 (Opicapone, OPC) - 200 mg
Intervention: BIA 9-1067 (Drug)
BIA 9-1067 400 mg
Experimental
BIA 9-1067 (Opicapone, OPC) - 400 mg
Intervention: BIA 9-1067 (Drug)
BIA 9-1067 800 mg
Experimental
BIA 9-1067 (Opicapone, OPC) - 800 mg
Intervention: BIA 9-1067 (Drug)
Outcomes
Primary Outcomes
Adverse Events (AEs)
Time Frame: 7 weeks
Safety was evaluated from the number of reported adverse events (AEs)
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
Loading locations...
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