Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Nebicapone 150 mg

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03097211
• Date of registration: 27/03/2017
• Prospective Registration: No
• Primary sponsor: Bial - Portela C S.A.
• Public title: Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Nebicapone 150 mg
• Scientific title: A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study in Healthy Volunteers to Investigate the Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Nebicapone 150 mg
• Date of first enrolment: July 17, 2006
• Target sample size: 38
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03097211
• 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 negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at
screening

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

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

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

- Subjects who were able and willing to gave 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 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 atopy.

- Subjects who had a history of relevant drug hypersensitivity.

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

- Subjects who consumed more than 14 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 (e.g., nausea, vomiting, diarrhoea,
heartburn) at the time of screening or admission.

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

- Subjects who had previously participated in a clinical trial with BIA 6-512.

- Subjects who had used any investigational drug or participated in any clinical trial
within 6 months prior to screening.

- Subjects who had participated in more than 2 clinical trials within the 12 months
prior to screening.

- Subjects who had donated or received any blood or blood products within the 3 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 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: Madopar® 250

Drug: Nebicapone

Drug: BIA 6-512

Drug: Placebo

Primary Outcome(s)

Day 4 - Area under the plasma concentration versus time curve from time zero to infinity (AUC0-8) [Time Frame: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8 and 16 hours post-dose.]

Day 4 - Time of occurrence of Cmax (tmax) [Time Frame: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8 and 16 hours post-dose.]

Day 5 - Apparent terminal elimination half-life, calculated from ln 2/?z (t1/2) [Time Frame: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 16 and 24 hours post-dose]

Day 5 - Maximum observed plasma drug concentration (Cmax) [Time Frame: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 16 and 24 hours post-dose]

Day 4 - AUC from time zero to 8 h post-dose (AUC0-t) [Time Frame: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8 and 16 hours post-dose.]

Day 4 - Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification (AUC0-t) [Time Frame: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8 and 16 hours post-dose.]

Day 5 - Area under the plasma concentration versus time curve from time zero to infinity (AUC0-8) [Time Frame: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 16 and 24 hours post-dose]

Day 5 - AUC from time zero to 8 h post-dose (AUC0-t) [Time Frame: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 16 and 24 hours post-dose]

Day 4 - Apparent terminal elimination half-life, calculated from ln 2/?z (t1/2) [Time Frame: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8 and 16 hours post-dose.]

Day 4 - Maximum observed plasma drug concentration (Cmax) [Time Frame: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8 and 16 hours post-dose.]

Day 5 - Time of occurrence of Cmax (tmax) [Time Frame: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 16 and 24 hours post-dose]

Day 5 - Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification (AUC0-t) [Time Frame: pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 16 and 24 hours post-dose]

Secondary ID(s)

BIA-6512-107

Source(s) of Monetary Support

Please refer to primary and secondary sponsors