NCT03665194 is a Phase 1 clinical trial of Cortexolone 17α-propionate solution in Healthy Volunteers, sponsored by Cassiopea SpA.

Who is sponsoring NCT03665194?

NCT03665194 is sponsored by Cassiopea SpA.

What drugs are being tested in NCT03665194?

Interventions in NCT03665194: Cortexolone 17α-propionate solution, Placebo.

What condition does NCT03665194 study?

NCT03665194 studies Healthy Volunteers.

Is NCT03665194 still recruiting?

NCT03665194 is currently completed. Last updated 4 February 2019.

Last reviewed 2019-02-04 · How we verify

NCT03665194

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 4 February 2019

What this trial tests

Phase 1 trial testing Cortexolone 17α-propionate solution in Healthy Volunteers in 32 participants. Completed in 12 September 2018.

Timeline

6 June 2018

Primary endpoint
12 September 2018

12 September 2018

Quick facts

Lead sponsor	Cassiopea SpA
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	32
Start date	6 June 2018
Primary completion	12 September 2018
Estimated completion	12 September 2018
Sites	1 location across United Kingdom

Drugs / interventions tested

Cortexolone 17α-propionate solution
Placebo

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Cassiopea SpA — full company profile →

Who can join

Adults 18 to 40, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

A Phase 1 Study to Investigate the Effects of Cortexolone 17α-Propionate, Also Known as Clascoterone, on the QT Interval Using the Meal Effect to Demonstrate ECG Assay Sensitivity.
Täubel J, Mazzetti A, Ferber G, Burch W, et al · · 2021 · cited 3× · PMID 33942574 · DOI 10.1002/cpdd.935
Is There a Clinically Relevant Risk of Hyperkalemia with Topical Clascoterone Treatment?
Del Rosso J, Stein Gold L, Squittieri N, Thiboutot D. · · 2023 · cited 1× · PMID 37361363

Verify or expand the search:

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

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NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting

Other Cassiopea SpA trials

Trials by the same sponsor.

NCT05914805 — A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (SCALP2) · Phase 3 · completed
NCT02720627 — An Evaluation of the Adrenal Suppression Potential and PK of CB-03-01 Cream in Pediatric Patients With Acne Vulgaris · Phase 2 · completed
NCT02682264 — An Open-Label, Long-Term Extension Study to Evaluate the Safety of CB-03-01 Cream, 1% in Participants With Acne Vulgaris · Phase 3 · completed
NCT02608450 — A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25) · Phase 3 · completed
NCT02608476 — A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (26) · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03665194 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cassiopea SpA
Last refreshed: 4 February 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03665194.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing