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

NCT03633591 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-01-31

No results posted yet for this study

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

Interventions

DRUG

Tolcapone

Multiple doses of tolcapone tablets in the fasted state

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)

Sponsors & Collaborators

  • Quotient Sciences

    collaborator INDUSTRY

  • Corino Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Litza McKenzie · Quotient Sciences

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-25
Primary Completion
2018-10-22
Completion
2018-10-22

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03633591 on ClinicalTrials.gov