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

NCT ID: NCT02169414

Last Updated: 2015-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-07-31

Brief Summary

The purpose of this study is to determine the effect of BIA 9 1067 (5 mg, 15 mg and 50 mg) in steady-state conditions on the levodopa pharmacokinetics of a single dose of immediate-release levodopa/carbidopa 100/25 mg and of a single dose of immediate-release levodopa/benserazide 100/25 mg.

Detailed Description

A single-centre, randomized, double-blind, gender-balanced, placebo-controlled study in 4 groups of 18 healthy subjects each. This study consisted of a once-daily administration of BIA 9 1067 (5 mg, 15 mg or 50 mg) or placebo for 18 days. Twelve (12) hours after the BIA 9 1067 dose, a single-dose of levodopa/carbidopa 100/25 mg was administered on Day 11 and a single-dose of levodopa/benserazide 100/25 mg was administered on Day 18.

Conditions

Parkinson's Disease (PD)

Keywords

Parkinson's disease (PD); BIA 9-1067; Opicapone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BIA 9-1067 5 mg

1 capsule of 5 mg + 2 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.

Group Type: EXPERIMENTAL

BIA 9-1067 5 mg

Intervention Type: DRUG

OPC, Opicapone

levodopa/carbidopa 100/25

Intervention Type: DRUG

immediate (standard) release levodopa/carbidopa 100/25

Placebo

Intervention Type: DRUG

PLC, Placebo

levodopa/benserazide 100/25 mg

Intervention Type: DRUG

immediate (standard) release levodopa/benserazide

BIA 9-1067 15 mg

3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.

Group Type: EXPERIMENTAL

BIA 9-1067 5 mg

Intervention Type: DRUG

OPC, Opicapone

levodopa/carbidopa 100/25

Intervention Type: DRUG

immediate (standard) release levodopa/carbidopa 100/25

levodopa/benserazide 100/25 mg

Intervention Type: DRUG

immediate (standard) release levodopa/benserazide

BIA 9-1067 50 mg

2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.

Group Type: EXPERIMENTAL

BIA 9-1067 25 mg

Intervention Type: DRUG

OPC, Opicapone

levodopa/carbidopa 100/25

Intervention Type: DRUG

immediate (standard) release levodopa/carbidopa 100/25

Placebo

Intervention Type: DRUG

PLC, Placebo

levodopa/benserazide 100/25 mg

Intervention Type: DRUG

immediate (standard) release levodopa/benserazide

Placebo

3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.

Group Type: PLACEBO_COMPARATOR

levodopa/carbidopa 100/25

Intervention Type: DRUG

immediate (standard) release levodopa/carbidopa 100/25

Placebo

Intervention Type: DRUG

PLC, Placebo

levodopa/benserazide 100/25 mg

Intervention Type: DRUG

immediate (standard) release levodopa/benserazide

Interventions

BIA 9-1067 5 mg

OPC, Opicapone

Intervention Type: DRUG

BIA 9-1067 25 mg

OPC, Opicapone

Intervention Type: DRUG

levodopa/carbidopa 100/25

immediate (standard) release levodopa/carbidopa 100/25

Intervention Type: DRUG

Placebo

PLC, Placebo

Intervention Type: DRUG

levodopa/benserazide 100/25 mg

immediate (standard) release levodopa/benserazide

Intervention Type: DRUG

Other Intervention Names

OPC, Opicapone; OPC, Opicapone; Sinemet®; PLC, Placebo; Madopar®

Eligibility 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bial - Portela C S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

BIOTRIAL

Rennes, , France

Countries

France

Other Identifiers

BIA-91067-123

Identifier Type: -

Identifier Source: org_study_id