Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT02169414
• Date of registration: 24/01/2012
• Prospective Registration: No
• Primary sponsor: Bial - Portela C S.A.
• Public title: Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics
• Scientific title: Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics of a Single-dose of Immediate Release 100/25 mg Levodopa/Carbidopa and 100/25 mg Levodopa/Benserazide in Healthy Subjects
• Date of first enrolment: February 2010
• Target sample size: 74
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02169414
• Study type: Interventional
• Phase: Phase 1

Countries of recruitment

France

Key inclusion & exclusion criteria

Inclusion Criteria:

- able to participate and willing to give written informed consent;

- male and female subjects;

- aged 18 to 45 years, inclusive;

- body mass index (BMI) between 18 and 30 kg/m2;

- healthy as determined by the Investigator on the basis of medical history, physical
examination, clinical laboratory test results, vital signs, complete neurological
examination and 12-lead electrocardiogram (ECG);

- negative tests for hepatitis B surface (HBs) antigen, anti-hepatitis C virus (HCV),
human immunodeficiency virus-1 (HIV-1) and HIV-2 antibodies at screening;

- negative screen for drugs of abuse and alcohol at screening and admission to the
treatment period;

- non-smokers or ex-smokers for at least 3 months;

- if sexually active, agreed to use a medically acceptable form of contraception
throughout the study;

- if female of childbearing potential, had a negative human chorionic gonadotropin (HCG)
beta serum pregnancy test at screening and admission to the treatment period.

Exclusion Criteria:

- who did not conform to the above inclusion criteria, or in case of volunteers who had
a clinically relevant surgical history, a clinically relevant family history; or who
had a history of relevant atopy;

- who had a significant infection or known inflammatory process at screening or
admission to the treatment period; acute gastrointestinal symptoms (e.g., nausea,
vomiting, diarrhea, heartburn) at the time of screening or admission to the treatment
period;

- who were vegetarians, vegans or had medical dietary restrictions;

- who could not communicate reliably with the Investigator;

- who were unlikely to co-operate with the requirements of the study; history of
hypersensitivity to BIA 9 1067, tolcapone, entacapone, levodopa, carbidopa,
benserazide or any related products (including excipients of the formulations) as well
as severe hypersensitivity reactions (like angioedema) to any drugs;

- any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g.
childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia),
immunologic, dermatological, haematological, neurologic, or psychiatric disease;

- any clinically significant illness in the previous 28 days before day 1 of this study;
history of drug abuse within 1 year before study day 1; history of alcoholism within 1
year before day 1.

- Consumption of more than 50 g of ethanol per day (12.5 cL glass of 10° [10%] wine = 12
g; 4 cL of aperitif, 42° [42%] whiskey = 17 g; 25 cL glass of 3° [3%] beer = 7.5 g; 25
cL glass of 6° [6%] beer = 15 g);

- poor motivation, intellectual problems likely to limit the validity of consent to
participate in the study or limit the ability to comply with the protocol requirements
or inability to cooperate adequately, inability to understand and to observe the
instructions of the physician;

- donation of blood (i.e., 450 mL) within 60 days before study day 1;

- positive urine screening of ethyl alcohol or drugs of abuse upon admission to the
treatment period;

- any history of tuberculosis and/or prophylaxis for tuberculosis; positive results to
HIV, hepatitis B surface antigen (HBsAg) or anti-HCV tests;

- participation in any previous clinical study with BIA 9 1067;

- if female, being pregnant or breast-feeding.



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

Health Condition(s) or Problem(s) studied

Parkinson's Disease (PD)

Intervention(s)

Drug: BIA 9-1067 5 mg

Drug: levodopa/benserazide 100/25 mg

Drug: BIA 9-1067 25 mg

Drug: levodopa/carbidopa 100/25

Drug: Placebo

Primary Outcome(s)

Tmax - Time to Reach Maximum Plasma Concentration of Levodopa (Levodopa/Carbidopa) [Time Frame: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.]

AUC0-8 - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity (Levodopa/Benserazide) [Time Frame: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.]

AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification. (Levodopa/Benserazide) [Time Frame: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose]

AUC0-8 - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity (Levodopa/Carbidopa) [Time Frame: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.]

AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification. (Levodopa/Carbidopa) [Time Frame: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.]

Tmax - Time to Reach Maximum Plasma Concentration of Levodopa (Levodopa/Benserazide) [Time Frame: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.]

Cmax - Maximum Plasma Concentration of Levodopa (Levodopa/Benserazide ) [Time Frame: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.]

Cmax - Maximum Plasma Concentration of Levodopa (Levodopa/Carbidopa) [Time Frame: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.]

Secondary ID(s)

BIA-91067-123

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/12/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02169414