Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02305017
Recruitment Status : Completed
First Posted : December 2, 2014
Results First Posted : November 18, 2015
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: BIA 9-1067 Drug: Paracetamol Phase 1

Detailed Description:
Single-centre, open-label, randomised, two-way cross-over study consisting of 2 periods separated by a washout period of 14 days or more. In one period, subjects received three single-doses of 1 g paracetamol separated by 6 hours and 1.5 hours after the last paracetamol dose a single-dose of 50 mg OPC was administered.In the other period, a single-dose of 50 mg OPC was administered alone.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers
Study Start Date : March 2014
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Period 1 OPC + Paracetamol; Period 2 OPC
Period 1 BIA 9-1067 (Opicapone, OPC) + Paracetamol; Period 2 BIA 9-1067 (Opicapone, OPC)
Drug: BIA 9-1067
BIA 9-1067 50 mg
Other Name: OPC, Opicapone

Drug: Paracetamol
Paracetamol 1g
Other Name: acetaminophen

Experimental: Period 1 OPC; Period 2 OPC+ Paracetamol
Period 1 BIA 9-1067 (Opicapone, OPC) Period 2 BIA 9-1067 (Opicapone, OPC) + Paracetamol;
Drug: BIA 9-1067
BIA 9-1067 50 mg
Other Name: OPC, Opicapone

Drug: Paracetamol
Paracetamol 1g
Other Name: acetaminophen




Primary Outcome Measures :
  1. Cmax - Maximum Plasma Concentration [ Time Frame: before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose ]
    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


Secondary Outcome Measures :
  1. Tmax - Time of Occurrence of Cmax [ Time Frame: before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose ]
    Tmax - time of occurrence of Cmax following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration.

  2. 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 [ Time Frame: 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 following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration

  3. AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity. [ Time Frame: before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose ]
    AUC0-∞ - AUC from time 0 to infinity following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 any clinically relevant abnormality in the liver function tests (a case-by-case decision for any abnormality must be discussed with the Sponsor before inclusion).
  • 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.
  • Subjects who cannot communicate reliably with the investigator.
  • Subjects who are unlikely to co-operate with the requirements of the study.
  • Subjects who are unwilling or unable to give written informed consent.
  • (If female) She is pregnant or breast-feeding.
  • (If female) She is of childbearing potential and she does not use an approved effective contraceptive method or she uses oral contraceptives.

Layout table for additonal information
Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02305017    
Other Study ID Numbers: BIA-91067-125
First Posted: December 2, 2014    Key Record Dates
Results First Posted: November 18, 2015
Last Update Posted: November 18, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Acetaminophen
Opicapone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Catechol O-Methyltransferase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiparkinson Agents
Anti-Dyskinesia Agents