Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-24 @ 5:45 PM
Study NCT ID:
NCT02092168
Status:
COMPLETED
Last Update Posted:
2015-01-14
First Post:
2012-01-20
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pharmacokinetics of BIA 9-1067 and Its Metabolites in Healthy Male Elderly Subjects and in Healthy Male Young Subjects
Sponsor:
Bial - Portela C S.A.
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: