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

Inclusion Criteria

All subjects (young and elderly):

• A signed and dated informed consent form before any study-specific screening procedure is performed.
• Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead electrocardiogram (ECG).
• Non-smoker or smoker of fewer than 10 cigarettes per day as determined by history. Had to be able to abstain from smoking during the inpatient stay.
• With a body mass index (BMI) between 19 and 30 kg/m2, inclusive.

Young subjects only:

• Males aged between 18 and 40 years, inclusive.

Elderly subjects only:

• Males older than 65 years, inclusive.

Exclusion Criteria

All subjects (young and elderly):

General

• Subjects who had participated in a clinical trial with an investigational drug within the 90 days prior to screening.
• Subjects who were likely to be noncompliant with the protocol, or who were felt to be unsuitable by the Investigator for any other reason.
• 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 (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA [3,4-ethylenedioxymethamphetamine; ecstasy]).

Medical History

• 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.
• 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).
• History of any clinically important drug allergy.
• Had previously received BIA 9-1067.

Prohibited treatments and dietary restrictions

• 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.

Young subjects only:

Prohibited treatments and dietary restrictions

• 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

• 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.