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A Study to Investigate the Effects of Cortexolone 17α-propionate (and Its Metabolites) on Healthy Volunteers' Heart

NCT03665194 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-02-04

No results posted yet for this study

Summary

This is a randomised, double blind placebo controlled Phase I study which will assess the safety, tolerability and PK of Cortexolone 17α-propionate (and its metabolites), and its effects on the QTc interval when administered as multiple doses to healthy adult volunteers. Volunteers will receive a morning and evening dose (12 hours apart) of 225 mg (3 mL Cortexolone 17α-propionate applied topically as a 7.5 % solution (75 mg in 1 mL), giving a total daily dose of 450 mg (6 mL) per individual.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Cortexolone 17α-propionate solution

Single topical application to be applied twice daily (0 hour and 12 hour) on Days 1-3 and Once Daily (0 hour) on Day 4.

DRUG

Placebo

matching placebo

Sponsors & Collaborators

  • Cassiopea SpA

    lead INDUSTRY

Principal Investigators

  • Jorg Taubel, MD FFPM · Richmond Pharmacology Limited

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-06-06
Primary Completion
2018-09-12
Completion
2018-09-12

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT03665194 on ClinicalTrials.gov