Pharmacokinetic Profile of BIA 6-512 in Healthy Elderly Subjects Versus Healthy Young Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03095105
• Date of registration: 23/03/2017
• Prospective Registration: No
• Primary sponsor: Bial - Portela C S.A.
• Public title: Pharmacokinetic Profile of BIA 6-512 in Healthy Elderly Subjects Versus Healthy Young Subjects
• Scientific title: An Open-label, Parallel-group Study to Compare the Pharmacokinetic Profile in Healthy Elderly Subjects Versus Healthy Young Subjects After Single and Repeated Oral Administration of BIA 6-512 (Trans-resveratrol)
• Date of first enrolment: January 24, 2006
• Target sample size: 25
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03095105
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female subjects aged between 18 and 40 years, inclusive (young); or male or
female subjects aged 65 years or more (elderly).

- Body mass index (BMI) between 19 and 30 kg/m2, inclusive.

- Healthy as determined by an inter¬view, pre-study medical history, physical
examination, vital signs, neurological examination and 12-lead ECG; clinical
laboratory test results clinically acceptable at screening and admission.

- Negative tests for HBsAg, anti-HCVAb, anti-HIV-1 Ab and anti-HIV-2 Ab at screening.

- Negative screen for drugs of abuse at screening and admission.

- Informed consent signed by the subject.

- Co-operative and available for the entire study.

- Abstinence from alcohol for 48 hours prior to admission (as stated by subject). An
alcohol breath test performed at screening and at admission to the clinic had to be
negative.

- Non-smokers or who smoke = 10 cigarettes or equivalent per day.

- If female, in the young group: She was not of childbearing potential by reason of
surgery or, if of childbearing potential, she used one of the following methods of
contraception: double barrier, intrauterine device or abstinence; and she had a
negative urine pregnancy test at screening and admission.

Exclusion Criteria:

- Evidence in the subject's medical history or in the medical exa¬mina¬tion of any
clinically significant respiratory, hepatic, renal, gastrointesti¬nal, haematological,
lymphatic, neurological, car¬diovascu¬lar, psychiatric, musculoskeletal,
genitourinary, immunological, dermatological, endocrine, connective tissue or other
significant acute or chronic abnormalities which might influence either the safety of
the subject or the ab¬sorption, dis¬tribution, meta¬bolism or excretion of the active
agent under investigation.

- History of relevant drug or food hypersensitivity.

- Significant infection or known inflammatory process on screening or admission.

- Acute gastrointestinal symptoms at the time of screening or admission (e.g., nausea,
vomiting, diarrhoea, heartburn).

- Regular use of any medication within four weeks prior to study admission
(self-medication or prescription).

- Single use of any medication (including OTC) that was not expressly permitted within
two weeks prior admission to the stu¬dy.

- Abuse of alcohol (equiv¬alent to more than 35 g ethanol per day).

- Vegetarians, vegans or subjects who had medical dietary restrictions.

- History of alcoholism or drug abuse.

- Participation in a clinical investigation within two months prior to screening.

- Blood donation of more than 250 ml within two months prior to screening. Blood
donation of less than 250 ml or plasma donation with¬in one month prior to screening.

- Subjects who were known or suspected:

- not to comply with the study directives

- not to be reliable or trustworthy

- not to be capable of understanding and evaluating the information given to them
as part of the formal information policy (informed consent), in particular
regarding the risks and discomfort to which they would agree to be exposed

- to be in such a precarious financial situation that they no longer weigh up the
possible risks of their participation and the unpleasantness they may be involved
in.

- If female, in the young group: she was pregnant or breast-feeding; she was of
childbearing potential and she did not use an approved effective contraceptive method
(double-barrier, intra-uterine device or abstinence) or she used oral contraceptives.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: 200 mg BIA 6-512

Primary Outcome(s)

AUCt- the area under the plasma concentration versus time curve over the dosing interval, calculated by the linear trapezoidal rule (Single dose) [Time Frame: Day 1: pre-dose 1, and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12 and 16 h post-dose]

AUC0-8 - the area under the plasma concentration versus time curve from time zero to infinity, calculated from AUC0-t + (Clast/lz ), where Clast is the last quantifiable concentration. (multiple dose) [Time Frame: Day 2: pre-dose 2; pre-dose 3 and pre-dose 4; day 3: pre-dose 5, pre-dose 6 and pre-dose 7; day 4: pre-dose 8 and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12 and 16 h post-dose; day 5: 24 h after last dose (dose 8).]

AUC0-8 - the area under the plasma concentration versus time curve from time zero to infinity, calculated from AUC0-t + (Clast/lz ), where Clast is the last quantifiable concentration. (single dose) [Time Frame: Day 1: pre-dose 1, and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12 and 16 h post-dose]

Cmax - the maximum observed plasma concentration (multiple dose) [Time Frame: Day 2: pre-dose 2; pre-dose 3 and pre-dose 4; day 3: pre-dose 5, pre-dose 6 and pre-dose 7; day 4: pre-dose 8 and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12 and 16 h post-dose; day 5: 24 h after last dose (dose 8).]

Cmax - the maximum observed plasma concentration (single dose) [Time Frame: Day 1: pre-dose 1, and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12 and 16 h post-dose]

AUCt - the area under the plasma concentration versus time curve over the dosing interval, calculated by the linear trapezoidal rule (multiple dose) [Time Frame: Day 2: pre-dose 2; pre-dose 3 and pre-dose 4; day 3: pre-dose 5, pre-dose 6 and pre-dose 7; day 4: pre-dose 8 and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12 and 16 h post-dose; day 5: 24 h after last dose (dose 8).]

Secondary ID(s)

BIA-6512-105

Source(s) of Monetary Support

Please refer to primary and secondary sponsors