Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers

NCT02305017 | Completed Phase 1 Results

• 1 other identifier: BIA-91067-125
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

Single-centre, open-label, randomised, two-way cross-over study consisting of 2 periods separated by a washout period of 14 days or more.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Cmax - Maximum Plasma Concentration

  Cmax - Maximum plasma concentration of opicapone on Day 12 following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration

  before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose

Secondary Outcomes (3)

• Tmax - Time of Occurrence of Cmax

  before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose

• AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification

  before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose

• AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity.

  before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose

Study Arms (2)

Period 1 OPC + Paracetamol; Period 2 OPC

EXPERIMENTAL

Period 1 BIA 9-1067 (Opicapone, OPC) + Paracetamol; Period 2 BIA 9-1067 (Opicapone, OPC)

Drug: BIA 9-1067; Drug: Paracetamol

Period 1 OPC; Period 2 OPC+ Paracetamol

EXPERIMENTAL

Period 1 BIA 9-1067 (Opicapone, OPC) Period 2 BIA 9-1067 (Opicapone, OPC) + Paracetamol;

Drug: BIA 9-1067; Drug: Paracetamol

Interventions

BIA 9-1067 DRUG

BIA 9-1067 50 mg

Also known as: OPC, Opicapone

Period 1 OPC + Paracetamol; Period 2 OPC; Period 1 OPC; Period 2 OPC+ Paracetamol

Paracetamol DRUG

Paracetamol 1g

Also known as: acetaminophen

Period 1 OPC + Paracetamol; Period 2 OPC; Period 1 OPC; Period 2 OPC+ Paracetamol

Eligibility Criteria

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

You may qualify if:

• Subjects who are able and willing to give written informed consent.
• Male or female subjects aged between 18 and 45 years, inclusive.
• Subjects of body mass index (BMI) between 19.0 and 30.0 kg/m2, inclusive.
• Subjects who are healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
• Subjects who have negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening.
• Subjects who have clinical laboratory test results clinically acceptable at screening and admission to each treatment period.
• Subjects who have a negative screen for alcohol and drugs of abuse at screening and admission to each treatment period.
• Subjects who are non-smokers or ex-smokers for at least 3 months.
• (If female) She is 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.
• (If female) She has 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:

• Subjects who have 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.
• Subjects who have a clinically relevant surgical history.
• Subjects who have any clinically relevant abnormality in the coagulation tests.
• Subjects who have a history of relevant atopy or drug hypersensitivity, particularly to paracetamol or any COMT inhibitor.
• Subjects who have a history of alcoholism or drug abuse.
• Subjects who consume more than 14 units of alcohol a week.
• Subjects who have a significant infection or known inflammatory process at screening or admission to each treatment period.
• Subjects who have acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period.
• Subjects who have received paracetamol within 2 weeks of admission to the first period.
• Subjects who have used any other medicines within 2 weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion.
• Subjects who have previously received OPC.
• Subjects who have used any investigational drug or participated in any clinical trial within 90 days prior to screening.
• Subjects who have participated in more than 2 clinical trials within the 12 months prior to screening.
• Subjects who have donated or received any blood or blood products within the 3 months prior to screening.
• Subjects who are vegetarians, vegans or have medical dietary restrictions.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

MeSH Terms

Conditions

Parkinson Disease

Interventions

opicapone; Acetaminophen

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

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: March 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: November 18, 2015
• Results First Posted: November 18, 2015

Record last verified: 2015-10