Relative Bioavailability and Bioequivalence Of Different Formulations of Opicapone in Healthy Volunteers

Parkinson Clinical Trial

Official title:

Relative Bioavailability and Bioequivalence Of Different Formulations of Opicapone in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02305277
• Other study ID #: BIA-91067-119
• Status: Completed
• Phase: Phase 1
• First received: November 28, 2014
• Last updated: October 14, 2015
• Start date: March 2014
• Est. completion date: June 2014

Study information

• Verified date: October 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, three-part, two-way crossover study in 84 healthy volunteers. In each part, the study consisted of two consecutive single-dose treatment periods separated by a washout period of at least 14 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• A signed and dated informed consent form before any study-specific screening procedure was performed;

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

• Body mass index (BMI) between 18 and 30 kg/m2 inclusive;

• 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 antibodies (HCV Ab) and anti-human immunodeficiency virus antibodies (HIV-1 and HIV-2 Ab) 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 to participate, and willing to give written informed consent and comply with the study restrictions.

• If female:

• She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used 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 all the duration of the study;

• She had a negative serum pregnancy test at screening and a negative urine pregnancy test at admission to each treatment period.

Exclusion Criteria:

• Subjects who had 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, or had a clinically relevant surgical history;

• Had clinically relevant findings in laboratory tests, particularly any abnormality in the coagulation tests, or any abnormality in the liver function tests;

• Had a history of relevant atopy or drug hypersensitivity;

• Had a history of alcoholism and/or drug abuse;

• Consumed 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°)];

• Had a significant infection or known inflammatory process on screening or admission to each treatment period;

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

• Had used medicines within 2 weeks of admission to first period that could affect the safety or other study assessments, in the Investigator's opinion;

• Had previously received opicapone;

• Had used any investigational drug or participated in any clinical trial within 90 days prior to screening;

• Had participated in more than 2 clinical trials within the 12 months prior to screening;

• Had donated or received any blood or blood products within the 3 months prior to screening;

• Were vegetarians, vegans or had medical dietary restrictions;

• Could not communicate reliably with the Investigator;

• Were unlikely to co-operate with the requirements of the study;

• Were unwilling or unable to give written informed consent;

If female:

• She was pregnant or breast-feeding.

Study Design

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

Related Conditions & MeSH terms

• Parkinson

Intervention

Drug:
• BIA 9-1067 (clinical micronized, CM)

• BIA 9-1067 (to-be-marketed, TBM)

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		before OPC dosing, and ½, 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 for BIA 9-1067	Area Under the plasma concentration-time Curve from time 0 to the time of last quantifiable concentration	before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose	No
Secondary	Tmax - Time of Occurrence of Cmax		before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose	No