Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone

Parkinson Disease Clinical Trial

Official title:

Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02305316
• Other study ID #: BIA-91067-120
• Status: Completed
• Phase: Phase 1
• First received: November 28, 2014
• Last updated: July 22, 2015
• Start date: February 2014
• Est. completion date: March 2014

Study information

• Verified date: July 2015
• Source: Bial - Portela C S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

Single-centre, open-label, randomised, two-way crossover study in 28 healthy volunteers. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 14 days or more.

Description:

Single-centre, open-label, randomised, two-way crossover study in 28 healthy volunteers. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 14 days or more. A total of twenty-eight (28) healthy volunteers received a single dose of 50 mg OPC, orally.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• A signed and dated informed consent form (ICF) before any study-specific screening procedure was performed,

• Male or female subjects aged 18 to 45 years, inclusive,

• Body mass index (BMI) between 19 and 30 kg/m2,

• Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead electrocardiogram (ECG),

• Negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies and anti-human immunodeficiency virus (HIV) antibodies at screening,

• Clinical laboratory test results clinically acceptable at screening and on D-1 of each treatment period,

• Negative screen for alcohol and drugs of abuse at screening and on D-1 of each treatment period,

• Non-smokers or ex-smokers for at least 3 months,

• Volunteer able to participate, and willing to give written informed consent and comply with the study restrictions,

If female:

• Was not of childbearing potential by reason of surgery or, if of childbearing potential, uses an effective non-hormonal method of contraception (intrauterine device or intrauterine system; condom or occlusive cap [diaphragm or cervical or vault caps] with spermicidal foam or gel or film or cream or suppository; true abstinence; or vasectomized male partner, provided that he was the sole partner of that subject) for the entire duration of the study,

• Negative serum pregnancy test at screening and a negative urine pregnancy test on D-1 of each treatment period.

Exclusion Criteria:

• Any 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, or had a clinically relevant surgical history,

• Any clinically relevant abnormality in the coagulation tests,

• Any clinically relevant abnormality in the liver function tests,

• History of relevant atopy or drug hypersensitivity,

• History of alcoholism and/or drug abuse,

• Current consumption of more than 14 units of alcohol per week [1 unit of alcohol = 280 mL beer (3-4°) = 100 mL wine (10-12°) = 30 mL spirits (40°)],

• Any significant infection or known inflammatory process on screening or admission to each treatment period,

• Any acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period,

• Use of medicines within 2 weeks of admission to first period that could affect the subject's safety or other study assessments, in the investigator's opinion,

• Previously received opicapone,

• Involvement in other clinical trials of any type within 90 days prior to screening,

• Participation in more than 2 clinical trials within the 12 months prior to screening,

• Blood donation or received any blood transfusion or any blood products within the 3 months prior to screening,

• Vegetarian, vegan or had medical dietary restrictions,

• Subject not able to 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:

• Pregnant or breast-feeding,

• If of childbearing potential, a positive serum pregnancy test,

• Volunteer who did not use an accepted effective contraceptive method or used oral contraceptives,

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• BIA 9-1067 non-micronized

• BIA 9-1067 micronized

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bial - Portela C S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax - Maximum Observed Plasma Concentration	Maximum observed plasma concentration of BIA 9-1067	before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.	No
Secondary	AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration	AUC0-t - Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration of BIA 9-1067	before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.	No
Secondary	Tmax - Time of Occurrence of Cmax of BIA 9-1067	tmax - time of occurrence of maximum observed plasma concentration of BIA 9-1067	before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.	No
Secondary	AUC0-inf - Area Under the Plasma Concentration-time Curve From Time 0 to the Infinity	AUC0-inf - Area under the plasma concentration-time curve from time 0 to the infinity.	before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.	No