Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-03-03 @ 2:06 PM
Study NCT ID:
NCT03665194
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2018-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Effects of Cortexolone 17α-propionate (and Its Metabolites) on Healthy Volunteers' Heart
Sponsor:
Cassiopea SpA
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: