Tolerability and Steady-state Pharmacokinetics of BIA 6-512

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03093389
• Date of registration: 22/03/2017
• Prospective Registration: No
• Primary sponsor: Bial - Portela C S.A.
• Public title: Tolerability and Steady-state Pharmacokinetics of BIA 6-512
• Scientific title: A Double-blind, Randomised, Placebo-controlled, Rising Multiple-dose Study to Investigate the Tolerability and Steady-state Pharmacokinetics of BIA 6-512 (Trans-resveratrol) in Healthy Volunteers
• Date of first enrolment: May 11, 2005
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03093389
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

Portugal

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female subjects aged between 18 and 45 years, inclusive.

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

- Subjects who were healthy as determined by pre-study medical history, physical
examination, vital signs, complete neurological examination and 12-lead ECG.

- Subjects who had clinical laboratory test results clinically acceptable at screening
and admission.

- Subjects who had negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at
screening.

- Subjects who had a negative screen for alcohol and drugs of abuse at screening and
admission.

- Subjects who were non-smokers or who smoke = 10 cigarettes or equivalent per day.

- Subjects who were able and willing to give written informed consent.

- (If female) 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.

- (If female) She had a negative urine pregnancy test at screening and admission.

Exclusion Criteria:

- Subjects who did not conform to the above inclusion criteria, or

- Subjects who had a clinically relevant history or presence of respiratory,
gastrointestinal, renal, hepatic, haematological, lymphatic, neurological,
cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological,
dermatological, endocrine, connective tissue diseases or disorders.

- Subjects who had a clinically relevant surgical history.

- Subjects who had a clinically relevant family history.

- Subjects who had a history of relevant drug or food hypersensitivity.

- Subjects who had a history of alcoholism or drug abuse.

- Subjects who consumed more than 21 units of alcohol a week.

- Subjects who had a significant infection or known inflammatory process on screening or
admission.

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

- Subjects who had used medicines within 2 weeks of first admission that, in the opinion
of the investigator, may affect the safety or other study assessments.

- Subjects who had used any investigational drug or participated in any clinical trial
within 2 months of their admission.

- Subjects who had donated or received any blood or blood products within the previous 2
months prior to screening.

- Subjects who were vegetarians, vegans or have medical dietary restrictions.

- Subjects who cannot communicate reliably with the investigator.

- Subjects who were unlikely to co-operate with the requirements of the study.

- Subjects who were unwilling or unable to give written informed consent.

- (If female) She was pregnant or breast-feeding.

- (If female) 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: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: BIA 6-512

Drug: Placebo

Primary Outcome(s)

AUC0-t - the area under the plasma concentration-time curve from time zero to the last sampling time at which concentrations are at or above the limit of quantification, calculated by the linear trapezoidal rule - first dose (dose 1) [Time Frame: Dose 1: pre-dose and ¼, ½, ¾, 1, 1½, 2, and 3 hours post-dose]

Cmax - the maximum plasma concentration - last dose (dose 13) [Time Frame: Dose 13: pre-dose and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose]

AUC0-t - the area under the plasma concentration versus time curve over the dosing interval (4 h), calculated by the linear trapezoidal rule - first dose (dose 1) [Time Frame: Dose 1: pre-dose and ¼, ½, ¾, 1, 1½, 2, and 3 hours post-dose]

AUC0-t - the area under the plasma concentration versus time curve over the dosing interval (4 h), calculated by the linear trapezoidal rule - last dose (dose 13) [Time Frame: Dose 13: pre-dose and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose]

t½ - the apparent elimination half-life, calculated from ln 2/lz - last dose (dose 13) [Time Frame: Dose 13: pre-dose and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose]

AUC0-t - the area under the plasma concentration-time curve from time zero to the last sampling time at which concentrations are at or above the limit of quantification, calculated by the linear trapezoidal rule - last dose (dose 13) [Time Frame: Dose 13: pre-dose and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose]

AUC0-¥ - 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 and lz the apparent terminal rate constant - first dose (dose 1) [Time Frame: Dose 1: pre-dose and ¼, ½, ¾, 1, 1½, 2, and 3 hours post-dose]

AUC0-¥ - 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 and lz the apparent terminal rate constant - last dose (dose 13) [Time Frame: Dose 13: pre-dose and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose]

Cmax - the maximum plasma concentration - first dose (dose 1) [Time Frame: Dose 1: pre-dose and ¼, ½, ¾, 1, 1½, 2, and 3 hours post-dose]

t½ - the apparent elimination half-life, calculated from ln 2/lz - first dose (dose 1) [Time Frame: Dose 1: pre-dose and ¼, ½, ¾, 1, 1½, 2, and 3 hours post-dose]

tmax - the time of occurrence of Cmax - first dose (dose 1) [Time Frame: Dose 1: pre-dose and ¼, ½, ¾, 1, 1½, 2, and 3 hours post-dose]

tmax - the time of occurrence of Cmax - last dose (dose 13) [Time Frame: Dose 13: pre-dose and ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose]

Secondary ID(s)

BIA-6512-103

Source(s) of Monetary Support

Please refer to primary and secondary sponsors