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

NCT02305316 | Completed Phase 1 Results

• 1 other identifier: BIA-91067-120
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration

  before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.

• Tmax - Time of Occurrence of Cmax 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.

• 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.

Study Arms (2)

BIA 9-1067 non-micronized - micronized

EXPERIMENTAL

Each subject was orally administered with 50 mg OPC non-micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC micronized

Drug: BIA 9-1067 non-micronized; Drug: BIA 9-1067 micronized

BIA 9-1067 micronized - non-micronized

EXPERIMENTAL

Each subject was orally administered 50 mg OPC micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC non-micronized

Drug: BIA 9-1067 non-micronized; Drug: BIA 9-1067 micronized

Interventions

BIA 9-1067 non-micronized DRUG

Also known as: OPC, Opicapone

BIA 9-1067 micronized - non-micronized; BIA 9-1067 non-micronized - micronized

BIA 9-1067 micronized DRUG

Also known as: OPC, Opicapone

BIA 9-1067 micronized - non-micronized; BIA 9-1067 non-micronized - micronized

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

MeSH Terms

Conditions

Parkinson Disease

Interventions

opicapone

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Head of Clinical Research
• Organization: Bial - Portela & Cª, S.A.

jose.rocha@bial.com

+351 229 866 100

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2014
• First Posted: December 2, 2014
• Study Start: February 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: August 21, 2015
• Results First Posted: August 21, 2015

Record last verified: 2015-07