Overview

Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453

Status:
Completed
Trial end date:
2008-07-01
Target enrollment:
0
Participant gender:
Male
Summary
The purpose of this study is to assess the tolerability of BIA 5-453 after six multiple rising dose regimens of BIA 5-453.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Bial - Portela C S.A.
Criteria
Inclusion Criteria:

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

4. Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must
have been able to abstain from smoking during the inpatient stay.

5. Have a high probability for compliance with and completion of the study.

Exclusion Criteria:

Medical History

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 Day1.

3. History of drug abuse within 1 year before study Day1.

4. History of alcoholism within 1 year before Day1. 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. History of any clinically important drug allergy.

Physical and Laboratory Findings

6. An automatic ECG QTc interval reading at screening or enrolment >450 ms.

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

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

Prohibited treatments

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 72 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 Day1.