Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation

NCT02305329 | Completed Phase 1 Results

• 1 other identifier: BIA-91067-121
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

Single-centre, open-label, randomized, two-sequence, two-way crossover study. The study consisted of two consecutive single-dose treatment periods separated by a washout period of 10 to 14 days or more.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Cmax - Maximum Observed Plasma Concentration of 9-1067

  Cmax - maximum observed plasma concentration of 9-1067.

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

Secondary Outcomes (3)

• Tmax - Time of Occurrence of Cmax of 9-1067

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

• AUC0-t - Area Under the Plasma Concentration-time Curve Calculated Between Time of Administration and Time t

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

• AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity

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

Study Arms (4)

Group 1 BIA 9-1067 25 mg

EXPERIMENTAL

Period 1 - 5x5 mg OPC Period 2 - 1x25 mg OPC

Drug: BIA 9-1067

Group 2 BIA 9-1067 25 mg

EXPERIMENTAL

Period 1 - 1x25 mg OPC Period 2 - 5x5 mg OPC

Drug: BIA 9-1067

Group 1 BIA 9-1067 50 mg

EXPERIMENTAL

Period 1 - 2x25 mg OPC Period 2 - 1x50 mg OPC

Drug: BIA 9-1067

Group 2 BIA 9-1067 50 mg

EXPERIMENTAL

Period 1 - 1x50 mg OPC Period 2 - 2x25 mg OPC

Drug: BIA 9-1067

Interventions

BIA 9-1067 DRUG

Also known as: OPC, Opicapone

Group 1 BIA 9-1067 25 mg; Group 1 BIA 9-1067 50 mg; Group 2 BIA 9-1067 25 mg; Group 2 BIA 9-1067 50 mg

Eligibility Criteria

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

You may qualify if:

• 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 ECG; - Negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C vírus (anti-HCV) antibodies, and anti-human immunodeficiency virus (HIV)-1/-2 antibodies at screening;
• Clinical laboratory test results clinically acceptable at screening and admission to each treatment period;
• Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period;
• Non-smokers or ex-smokers for at least 3 months;
• Able and willing to give written informed consent;
• If female: She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used an effective nonhormonal 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 all the duration of the study; and she had a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1 of each treatment period.

You may not qualify if:

• A 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;
• A clinically relevant surgical history;
• Any clinically relevant abnormality in the coagulation tests;
• Any clinically relevant abnormality in the liver function tests. If the subject had a borderline clinically relevant abnormality that was not considered clinically significant, a retest could be done after discussion with the sponsor's medical monitor;
• A history of relevant atopy or drug hypersensitivity;
• A history of alcoholism or drug abuse;
• Consume more than 14 units of alcohol a week;
• A significant infection or known inflammatory process on screening or admission to each treatment period;
• Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period;
• Used medicines within 2 weeks of admission to first period that could have affected the subject's safety or other study assessments in the investigator's opinion;
• Previously received OPC. Previous use of OPC was documented by questioning the subjects;
• Used any investigational drug or participated in any clinical trial within 90 days prior to screening
• Participated in more than 2 clinical trials within the 12 months prior to screening;
• Donated or received any blood or blood products within the 3 months prior to screening;
• Vegetarians, vegans or have medical dietary restrictions;

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

MeSH Terms

Conditions

Epilepsy

Interventions

opicapone

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System 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: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: August 21, 2015
• Results First Posted: August 21, 2015

Record last verified: 2015-07