Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Benserazide (100/25 mg)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 May 2016
• Main ID: NCT02763852
• Date of registration: 04/05/2016
• Prospective Registration: No
• Primary sponsor: Bial - Portela C S.A.
• Public title: Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Benserazide (100/25 mg)
• Scientific title: Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Benserazide (100/25 mg): a Double-blind, Randomised, Crossover, Placebo Controlled Study in Healthy Volunteers
• Date of first enrolment: April 2001
• Target sample size: 18
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02763852
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Portugal

Key inclusion & exclusion criteria

Inclusion Criteria:

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

- Subjects of body mass index (BMI) between 19 and 28 kg/m2, inclusive.

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

- Subjects who had clinical laboratory tests acceptable to the investigator.

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

- Subjects who were negative for drugs of abuse at screening and admission.

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

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

- (If a woman) 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.

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, 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 28 units of alcohol a week.

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

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

- Subjects who had an acute infection such as influenza at the time of screening and/or
admission.

- Subjects who had used prescription drugs within 4 weeks of first dosing.

- Subjects who had used oral contraceptives or over the counter medication excluding
oral routine vitamins but including mega dose vitamin therapy within one week of
first dosing.

- Subjects who had used any investigational drug and/or participated in any clinical
trial within 3 months of their first admission to the study.

- Subjects who had previously received BIA 3-202.

- Subjects who had donated and/or received any blood or blood products within the
previous 3 months prior to screening.

- Subjects who were vegetarians, vegans and/or had medical dietary restrictions.

- Subjects who could not communicate reliably with the investigator.

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

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

- (If woman) She was at childbearing potential and she did not use an approved
effective contraceptive method or she used oral contraceptives.

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



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Placebo

Drug: BIA 3-202

Drug: Madopar® 125

Primary Outcome(s)

Maximum observed plasma concentration (Cmax) [Time Frame: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18 and 24 h post-dose]

Area under the plasma concentration time curve extrapolated to infinity (AUC0-8) [Time Frame: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18 and 24 h post-dose]

Apparent terminal elimination half-life (t1/2) [Time Frame: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18 and 24 h post-dose]

Secondary ID(s)

BIA-3202-104

Source(s) of Monetary Support

Please refer to primary and secondary sponsors