Effect of Food on Opicapone

Parkinson Disease Clinical Trial

Official title:

Effect of Food on Opicapone Bioavailability and Pharmacodynamics in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03116308
• Other study ID #: BIA-91067-128
• Status: Completed
• Phase: Phase 1
• First received: April 12, 2017
• Last updated: April 12, 2017
• Start date: November 21, 2014
• Est. completion date: January 28, 2015

Study information

• Verified date: April 2017
• Source: Bial - Portela C S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of food on the catechol-O-Methyltransferase (COMT) activity after repeated doses of opicapone (OPC, development code BIA 9-1067) in healthy subjects and to characterize the effects of food on the pharmacokinetics (PK) and tolerability of OPC after repeated doses.

Description:

Single-centre, open-label, single-arm study in 28 healthy subjects. Subjects received a single-dose of 50 mg OPC once-daily (QD) in the evening for 12 days. On Day 1 (D1), 50 mg OPC was orally administered in the evening (reference hour for all other administrations) after a minimum of 6 hours fast. From D2 to D8 subjects were in ambulatory and received 50 mg OPC once-daily (evening administration after 2 hours fast). On D9, 50 mg OPC was orally administered in the evening after a minimum of 6 hours fast. On D10, 50 mg OPC was orally administered in the evening, thirty minutes after the start of a moderate meal (with a previous 6 hours fast). On D11 and D12 subjects received the last doses of 50 mg OPC (evening administration after 2 hours fast).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 28, 2015
• Est. primary completion date: January 28, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Able and willing to give written informed consent and to comply with the study restrictions.

• Male or female subjects aged between 18 and 45 years, inclusive.

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

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

• Negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at screening.

• Clinical laboratory test results clinically acceptable at screening and admission.

• Negative screen for alcohol and drugs of abuse at screening and admission.

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

• If female:

• Not of childbearing potential by reason of surgery or, if of childbearing potential, she 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 is the sole partner of that subject) for all the duration of the study.

• Negative serum pregnancy test at screening and a negative urine pregnancy test on admission.

Exclusion Criteria:

• 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.

• Clinically relevant surgical history.

• Clinically relevant abnormality in the coagulation tests.

• Clinically relevant abnormality in the liver function tests.

• History of relevant atopy or drug hypersensitivity, particularly to any COMT inhibitor.

• History of alcoholism or drug abuse.

• Consume more than 14 units of alcohol a week.

• Significant infection or known inflammatory process at screening or admission.

• Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission.

• Used medicines within 2 weeks of admission that may affect the safety or other study assessments, in the investigator's opinion.

• Previously received OPC.

• 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.

• Cannot communicate reliably with the investigator.

• Unlikely to co-operate with the requirements of the study.

• If female:

• Pregnant or breast-feeding.

• Of childbearing potential and not used an approved effective contraceptive method or she uses oral contraceptives.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Opicapone (OPC)
50 mg OPC capsules; oral route

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	Maximum observed effect on COMT activity (Emax) - Day 9 (fasted state)	Pharmacodynamic parameters for opicapone	Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Primary	Time to occurrence of Emax (tEmax) - Day 9 (fasted state)	Pharmacodynamic parameters for opicapone	Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Primary	Area under the effect-time curve (AUEC) - Day 9 (fasted state)	Pharmacodynamic parameters for opicapone	Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Primary	Maximum observed effect on COMT activity (Emax) - Day 10 (fed state)	Pharmacodynamic parameters for opicapone	Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Primary	Time to occurrence of Emax (tEmax) - Day 10 (fed state)	Pharmacodynamic parameters for opicapone	Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Primary	Area under the effect-time curve (AUEC) - Day 10 (fed state)	Pharmacodynamic parameters for opicapone	Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Secondary	Maximum observed plasma concentration (Cmax) - Day 9 (fasted state)	Pharmacokinetic parameters for opicapone	Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Secondary	Time of occurrence of Cmax (tmax) - Day 9 (fasted state)	Pharmacokinetic parameters for opicapone	Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Secondary	Maximum observed plasma concentration (Cmax) - Day 10 (fed state)	Pharmacokinetic parameters for opicapone	Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose
Secondary	Time of occurrence of Cmax (tmax) - Day 10 (fed state)	Pharmacokinetic parameters for opicapone	Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose