NCT03665194

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

A Randomised, Double Blind, Placebo Controlled Phase I Study to Investigate the Effects of Systemically Absorbed Cortexolone 17α-propionate (and Its Metabolites) on QT Interval Following Repeat Topical Administration in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Cassiopea SpA · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

Thirty-two volunteers will be enrolled and evaluated (i.e. complete the study). Subjects will be dosed in four groups of eight (purely for logistical reasons relating to the procedure times expected with dosing and ECG). Volunteers will receive either the active drug or matching placebo in a 3:1 ratio. Therefore within each cohort, six volunteers will receive the active drug and two will receive matching placebo. Volunteers will be screened within 20 days prior to entering the study on Day -1. Each volunteer will receive verbal and written information followed by signing of the ICF prior to any screening procedures taking place. Volunteers will be admitted to the study unit on Day -1, dosed twice daily on Days 1-3 and once on Day 4 (morning dose only). They will be discharged on Day 6 and will have a telephone follow-up on Day 14. If they report any relevant Adverse Event (AE) they will be invited to attend the unit for an outpatient visit as close to Day 14 as is possible.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-06-06
• Primary completion: 2018-09-12
• Completion: 2018-09-12
• First posted: 2018-09-11
• Last updated: 2019-02-04

Locations

1 site across 1 country: United Kingdom