A Study Assessing the Safety and Pharmacokinetic Profile of Modified Release Formulations of Tolcapone

January 30, 2019 updated by: Corino Therapeutics, Inc.

A Phase 1, Single-Part, 6-Period, Sequential, Non-Randomized, Open-Label Study Designed to Evaluate the Pharmacokinetic Profile of Tolcapone Following Administration of Modified Release Prototype Formulations and an Experimental Divided Dose Regimen in Healthy Subjects

The purpose of this study is to assess the pharmacokinetic profiles of tolcapone in healthy subjects after administration of one or two oral doses of multiple modified release prototype formulations.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Nottingham
      • Ruddington, Nottingham, United Kingdom, NG11 6JS
        • Quotient Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy males or non-pregnant, non-lactating healthy females
  • Age 18 to 65 years of age at the time of signing informed consent
  • Body mass index (BMI) of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
  • Must be willing and able to communicate and participate in the whole study
  • Must provide written informed consent
  • Must agree to use an adequate method of contraception

Exclusion Criteria:

  • Subjects who have received any IMP in a clinical research study within the previous 3 months prior to first dose.
  • Subjects who are study site employees, or immediate family members of a study site or sponsor employee.
  • Subjects who have previously been enrolled in this study.
  • History of any drug or alcohol abuse in the past 2 years.
  • Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
  • Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
  • Females of childbearing potential who are pregnant or lactating
  • Subjects who do not have suitable veins for multiple venepunctures / cannulation as assessed by the investigator at screening
  • Clinically significant abnormal biochemistry, hematology or urinalysis as judged by the investigator
  • Hemoglobin below the lower limit of normal
  • ALT or AST outside the normal reference range at screening or admission.
  • Confirmed positive drugs of abuse test result
  • Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
  • History of clinically significant cardiovascular, neurological, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorder, as judged by the investigator
  • Subjects with a history of cholecystectomy or gall stones
  • Serious adverse reaction or serious hypersensitivity to any drug, the formulation excipients, or lactose intolerance
  • Presence or history of clinically significant allergy requiring treatment, as judged by the investigator.
  • Donation or loss of greater than 400 mL of blood within the previous 3 months
  • Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies in the 14 days before IMP administration.
  • Contraindication for Tasmar®
  • Failure to satisfy the investigator of fitness to participate for any other reason

NOTE: Other inclusion/exclusion criteria may apply, per protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Modified Release Prototypes of Tolcapone
Drug: Tolcapone
Multiple doses of tolcapone tablets in the fasted state
Other Names:
  • Tasmar
Drug: Tolcapone Modified Release Prototype
A single dose of tolcapone modified release prototype in the fasted state
Drug: Tolcapone Divided Dose
Tolcapone (suspension) in equal divided doses in the fasted state
Drug: Tolcapone Modified Release Prototype
A single dose of tolcapone modified release prototype (optionally two doses or fed state of prior MR prototype)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetic Assessment: Time to maximum concentration (Tmax)
Time Frame: Pre-dose to 24 hours post-dose
Time to maximum concentration (Tmax)
Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment: Maximum observed concentration (Cmax)
Time Frame: Pre-dose to 24 hours post-dose
Maximum observed concentration (Cmax)
Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment: Area under the curve (AUC)
Time Frame: Pre-dose to 24 hours post-dose
Area under the curve (AUC)
Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment: Plasma half-life (t1/2)
Time Frame: Pre-dose to 24 hours post-dose
Plasma half-life (t1/2)
Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment: Relative bioavailability (Frel)
Time Frame: Pre-dose to 24 hours post-dose
Relative bioavailability (Frel)
Pre-dose to 24 hours post-dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetic Assessment of 3-O-Methyltolcapone: Time to maximum concentration (Tmax)
Time Frame: Pre-dose to 24 hours post-dose
Time to maximum concentration (Tmax)
Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment of 3-O-Methyltolcapone: Maximum observed concentration (Cmax)
Time Frame: Pre-dose to 24 hours post-dose
Maximum observed concentration (Cmax)
Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment of 3-O-Methyltolcapone: Area under the curve (AUC)
Time Frame: Pre-dose to 24 hours post-dose
Area under the curve (AUC)
Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment of 3-O-Methyltolcapone: Plasma half-life (t1/2)
Time Frame: Pre-dose to 24 hours post-dose
Plasma half-life (t1/2)
Pre-dose to 24 hours post-dose
Pharmacokinetic Assessment of 3-O-Methyltolcapone: Relative Bioavailability (Frel)
Time Frame: Pre-dose to 24 hours post-dose
Relative Bioavailability (Frel)
Pre-dose to 24 hours post-dose
Number of subjects reporting treatment-related Adverse Events (AEs)
Time Frame: Screening to 10 days following last dose
Abnormalities in safety laboratory tests, vital signs, electrocardiogram, physical examination that meet the protocol definition will be captured as AEs
Screening to 10 days following last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Corino Therapeutics, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Quotient Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Litza McKenzie, Quotient Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 25, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 22, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 22, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TOLC101MR
  • 2017-003070-13 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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