Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation

Epilepsy Clinical Trial

Official title:

Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02305329
• Other study ID #: BIA-91067-121
• Status: Completed
• Phase: Phase 1
• First received: November 28, 2014
• Last updated: July 22, 2015
• Start date: February 2014
• Est. completion date: April 2014

Study information

• Verified date: July 2015
• Source: Bial - Portela C S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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. In Group 1 the volunteers received a single oral dose of 25 mg OPC. In Group 2 the volunteers received a single oral dose of 50 mg OPC

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;

• Not able to communicate reliably with the investigator;

• Unlikely to co-operate with the requirements of the study; unwilling or unable to give written informed consent;

• If female: she was pregnant or breast-feeding; she had a positive serum pregnancy test; she was of childbearing potential and did not use an accepted effective contraceptive method or she 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

• Epilepsy

Intervention

Drug:
• BIA 9-1067

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 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	No
Secondary	Tmax - Time of Occurrence of Cmax of 9-1067	tmax - time of occurrence of 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	No
Secondary	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	No
Secondary	AUC0-8 - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity	AUC0-8 - 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	No