Pharmacokinetics of BIA 9-1067 and Its Metabolites in Healthy Male Elderly Subjects and in Healthy Male Young Subjects

Exclusion Criteria

• •All subjects (young and elderly):
• •General
• •1. Subjects who had participated in a clinical trial with an investigational drug within the 90 days prior to screening.
• •2. Subjects who were likely to be noncompliant with the protocol, or who were felt to be unsuitable by the Investigator for any other reason.
• •3. Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
• •4. Positive findings of urine drug screen (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA \[3,4-ethylenedioxymethamphetamine; ecstasy\]).
• •Medical History
• •5. Any significant cardiovascular, hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes,), immunological, dermatological, haematological, neurological, or psychiatric disease and history thereof.
• •6. Acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study Day 1.
• •7. History of drug abuse within 1 year before study Day 1.
• •8. 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).
• •9. History of any clinically important drug allergy.
• •10. Had previously received BIA 9-1067.
• •Prohibited treatments and dietary restrictions
• •11. 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.
• •12. 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.
• •13. Donation of blood (i.e. 450 ml) within 60 days before study Day 1.
• •Young subjects only:
• •Prohibited treatments and dietary restrictions
• •14. Prohibited Treatments: use of any investigational drug within 90 days (young and elderly subjects) or prescription drug within 30 days before investigational medical product (IMP) administration.
• •Elderly subjects only:
• •Prohibited treatments and dietary restrictions
• •15. For elderly subjects, previously prescribed medications that do not interfere with absorption, distribution, metabolism, and excretion or safety/tolerability evaluation of BIA 9-1067 and adrenal or renal function were allowed if the dose regimen had been stable for at least 4 weeks and was expected to remain stable throughout the study. Such concomitant medications was reviewed and mutually agreed upon by the sponsor and the investigator.