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

Sponsor
Corino Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03633591
Collaborator
Quotient Sciences (Industry)
12
Enrollment
1
Location
1
Arm
3.9
Actual Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tolcapone
  • Drug: Tolcapone Modified Release Prototype
  • Drug: Tolcapone Divided Dose
  • Drug: Tolcapone Modified Release Prototype
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
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
Actual Study Start Date :
Jun 25, 2018
Actual Primary Completion Date :
Oct 22, 2018
Actual Study Completion Date :
Oct 22, 2018

Arms and Interventions

Arm Intervention/Treatment
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)

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetic Assessment: Time to maximum concentration (Tmax) [Pre-dose to 24 hours post-dose]

      Time to maximum concentration (Tmax)

    2. Pharmacokinetic Assessment: Maximum observed concentration (Cmax) [Pre-dose to 24 hours post-dose]

      Maximum observed concentration (Cmax)

    3. Pharmacokinetic Assessment: Area under the curve (AUC) [Pre-dose to 24 hours post-dose]

      Area under the curve (AUC)

    4. Pharmacokinetic Assessment: Plasma half-life (t1/2) [Pre-dose to 24 hours post-dose]

      Plasma half-life (t1/2)

    5. Pharmacokinetic Assessment: Relative bioavailability (Frel) [Pre-dose to 24 hours post-dose]

      Relative bioavailability (Frel)

    Secondary Outcome Measures

    1. Pharmacokinetic Assessment of 3-O-Methyltolcapone: Time to maximum concentration (Tmax) [Pre-dose to 24 hours post-dose]

      Time to maximum concentration (Tmax)

    2. Pharmacokinetic Assessment of 3-O-Methyltolcapone: Maximum observed concentration (Cmax) [Pre-dose to 24 hours post-dose]

      Maximum observed concentration (Cmax)

    3. Pharmacokinetic Assessment of 3-O-Methyltolcapone: Area under the curve (AUC) [Pre-dose to 24 hours post-dose]

      Area under the curve (AUC)

    4. Pharmacokinetic Assessment of 3-O-Methyltolcapone: Plasma half-life (t1/2) [Pre-dose to 24 hours post-dose]

      Plasma half-life (t1/2)

    5. Pharmacokinetic Assessment of 3-O-Methyltolcapone: Relative Bioavailability (Frel) [Pre-dose to 24 hours post-dose]

      Relative Bioavailability (Frel)

    6. Number of subjects reporting treatment-related Adverse Events (AEs) [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Quotient Sciences Ruddington Nottingham United Kingdom NG11 6JS

    Sponsors and Collaborators

    • Corino Therapeutics, Inc.
    • Quotient Sciences

    Investigators

    • Principal Investigator: Litza McKenzie, Quotient Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Corino Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT03633591
    Other Study ID Numbers:
    • TOLC101MR
    • 2017-003070-13
    First Posted:
    Aug 16, 2018
    Last Update Posted:
    Jan 31, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Tolcapone

    Study Results

    No Results Posted as of Jan 31, 2019