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

Corino Therapeutics

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Tolcapone Divided Dose

Drug: Tolcapone

Drug: Tolcapone Modified Release Prototype

Study type

Interventional

Funder types

Industry

Identifiers

NCT03633591

2017-003070-13 (EudraCT Number)

TOLC101MR

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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