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Study to Evaluate the PK of Single and Optional Multiple Dosing Regimens of MR Formulations of PCS499 Compared to Trental® Administered to Healthy Subjects

NCT03836222 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-02-12

No results posted yet for this study

Summary

This was a Phase I, single centre, open-label, non-randomised study and was designed to be conducted in up to 2 parts. The purpose of Part 1 was to identify a MR formulation of PCS499 that would provide an optimal dosing regimen in patients. The purpose of Part 2 of the study was to generate repeat dose information for the selected MR formulation of PCS499 in order to provide additional PK information for future patient studies.

Conditions

  • Healthy

Interventions

DRUG

PCS499

MR tablet

DRUG

Trental

comparator tablet

Sponsors & Collaborators

  • Quotient Sciences

    collaborator INDUSTRY

  • Processa Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Sharan Sidhu, MBChB · Quotient Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2018-02-26
Primary Completion
2018-06-04
Completion
2018-06-04

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 NCT03836222 on ClinicalTrials.gov