Effect of Food on Opicapone

NCT03116308 | Completed Phase 1

• 1 other identifier: BIA-91067-128
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• Maximum observed plasma concentration (Cmax) - Day 9 (fasted state)

  Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose

• Time of occurrence of Cmax (tmax) - Day 9 (fasted state)

  Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose

• Maximum observed plasma concentration (Cmax) - Day 10 (fed state)

  Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose

• Time of occurrence of Cmax (tmax) - Day 10 (fed state)

  Before and ½, 1, 2, 3, 4, 6, 12 and 24 h post-dose

Study Arms (1)

50 mg OPC

EXPERIMENTAL

Subjects received 50 mg OPC once-daily in the evening for 12 days. On D9 subjects were to receive 50 mg OPC in the evening after a minimum 6 hours fast. On D10 subjects were to receive the QD dose of 50 mg OPC thirty minutes after the start of moderate meal (with a previous 6 hours fast)

Drug: Opicapone (OPC)

Interventions

Opicapone (OPC) DRUG

50 mg OPC capsules; oral route

Also known as: Ongentys, BIA 9-1067

50 mg OPC

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

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

Study Design

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

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 17, 2017
• Study Start: November 21, 2014
• Primary Completion: January 28, 2015
• Study Completion: January 28, 2015
• Last Updated: April 17, 2017

Record last verified: 2017-04