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

NCT ID: NCT03633591

Last Updated: 2019-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-25
• Study Completion Date: 2018-10-22

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Modified Release Prototypes of Tolcapone

Group Type: EXPERIMENTAL

Tolcapone

Intervention Type: DRUG

Multiple doses of tolcapone tablets in the fasted state

Tolcapone Modified Release Prototype

Intervention Type: DRUG

A single dose of tolcapone modified release prototype in the fasted state

Tolcapone Divided Dose

Intervention Type: DRUG

Tolcapone (suspension) in equal divided doses in the fasted state

Tolcapone Modified Release Prototype

Intervention Type: DRUG

A single dose of tolcapone modified release prototype (optionally two doses or fed state of prior MR prototype)

Interventions

Tolcapone

Multiple doses of tolcapone tablets in the fasted state

Intervention Type: DRUG

Tolcapone Modified Release Prototype

A single dose of tolcapone modified release prototype in the fasted state

Intervention Type: DRUG

Tolcapone Divided Dose

Tolcapone (suspension) in equal divided doses in the fasted state

Intervention Type: DRUG

Tolcapone Modified Release Prototype

A single dose of tolcapone modified release prototype (optionally two doses or fed state of prior MR prototype)

Intervention Type: DRUG

Other Intervention Names

Tasmar

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Quotient Sciences

INDUSTRY

Sponsor Role: collaborator

Corino Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Litza McKenzie

Role: PRINCIPAL_INVESTIGATOR

Quotient Sciences

Locations

Quotient Sciences

Ruddington, Nottingham, United Kingdom

Countries

United Kingdom

Other Identifiers

2017-003070-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TOLC101MR

Identifier Type: -

Identifier Source: org_study_id