Single-dose and Steady-state Pharmacokinetics of BIA 9-1067 and Its Metabolites in Healthy Male Elderly Subjects Compared With Those in Healthy Male Young Subjects
Overview
- Phase
- Phase 1
- Intervention
- BIA 9-1067
- Conditions
- Parkinson Disease
- Sponsor
- Bial - Portela C S.A.
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Cmax - Maximum Plasma Concentration
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this study is to determine the effects of age on the pharmacokinetic (PK) profile of BIA 9-1067 and its metabolites.
Detailed Description
Methodology: Single-centre, open-label, parallel group, non-randomised multiple-dose 7-day study in 12 healthy elderly and 12 healthy younger male subjects. Duration of treatment: Each subject participated in the study for approximately 6 weeks. Participation included a screening evaluation within 28 days before inpatient period, a 12 day inpatient period and an end of study visit (ESV) 7 to 10 days after the discharge from the Unit. The study design followed the recommendations of the CPMP/ICH/379/95 (ICH Topic E7) Note for Guidance on Studies in Support of Special Populations: Geriatrics, namely in the inclusion of subjects aged 65 years or older and contemplating single-dose and steady-state PK profiles. As the primary endpoint of the study was to characterize the pharmacokinetic profile of BIA 9-1067 and its metabolites in different parallel groups, there was no need to implement blinding procedures or to include a control group. Consequently, the trial was an open label study. Healthy subjects rather than patients with Parkinson's disease have been chosen as the study population, due to the lack of over-toxicity of the drug and an acceptable risk-benefit ratio. This allowed for a better interpretation of the study results, as there were no confounding factors resulting from changes in disease state and or concomitant medications. The subjects were given a screening number after signing the informed consent by chronological order of inclusion in each group (young/elderly).
Investigators
Eligibility Criteria
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):
- •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
- •History of drug abuse within 1 year before study Day
- •History of alcoholism within 1 year before Day
Arms & Interventions
BIA 9-1067 30 mg (once daily) - Elderly Subjects
BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
Intervention: BIA 9-1067
BIA 9-1067 30 mg (once daily) - Young Subjects
BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
Intervention: BIA 9-1067
Outcomes
Primary Outcomes
Cmax - Maximum Plasma Concentration
Time Frame: Day 1 and Day 7
Cmax (BIA 9-1067) - maximum plasma concentration of BIA 9-1067
Tmax - Time to Reach Cmax
Time Frame: Day 1 and Day 7
Tmax - Time to reach maximum plasma concentration of BIA 9-1067
AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration
Time Frame: Day 1 and Day 7
AUC0-t - Area under the plasma concentration-time curve of BIA 9-1067 from time 0 to last observed concentration