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NCT03315338
First-in-human Study in Healthy Subjects
Phase 1 trial testing CORT118335, 25 mg in Healthy in 143 participants. Completed in 22 February 2019.
22 February 2019
Quick facts
| Lead sponsor | Corcept Therapeutics |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | basic science |
| Enrollment | 143 |
| Start date | 15 September 2017 |
| Primary completion | 22 February 2019 |
| Estimated completion | 22 February 2019 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- CORT118335, 25 mg
- Prednisone Oral Tablet
- Glucose
- Placebo oral suspension
- CORT118335, 75mg
- CORT118335, 225mg
- CORT118335, 675mg — full drug profile →
- CORT118335, 600mg — full drug profile →
- CORT118335, 630mg
- CORT118335, 375mg — full drug profile →
- CORT118335, 100mg
- CORT118335, 300mg
- CORT118335, 900mg — full drug profile →
- CORT118335, 150mg
- CORT118335, 1500mg
- Placebo oral capsule
- CORT118335, dose to be determined — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Corcept Therapeutics — full company profile →
Who can join
Adults 18 to 60, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This initial Phase I study will evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending doses of CORT118335, the effect of concomitant administration with food on exposure to CORT118335, and its pharmacological effect in healthy subjects.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Effect of Miricorilant, a Selective Glucocorticoid Receptor Modulator, on Olanzapine-Associated Weight Gain in Healthy Subjects: A Proof-of-Concept Study.
Hunt HJ, Donaldson K, Strem M, Tudor IC, et al · · 2021 · cited 6× · PMID 34369902 · DOI 10.1097/jcp.0000000000001470 -
Evaluation of the Pharmacokinetics, Disposition, and Metabolism of Miricorilant, a Novel Glucocorticoid Receptor Modulator for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis in Nonclinical and Clinical Studies.
Hunt HJ, Donaldson KM, Kunta JR, Custodio JM. · · 2026 · PMID 41014112 · DOI 10.1002/jcph.70113
Verify or expand the search:
- PubMed search for NCT03315338
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Corcept Therapeutics trials
Trials by the same sponsor.
- NCT07240116 — Study Evaluating the Bioavailability of Miricorilant With Optional Food Effect Assessment in Healthy Adult Subjects · Phase 1 · completed
- NCT06829537 — Study of the Prevalence of Endogenous Hypercortisolism in Patients With Resistant Hypertension (MOMENTUM) · completed
- NCT06928779 — Effects of Hepatic Impairment on the Pharmacokinetics of Dazucorilant · Phase 1 · completed
- NCT06495944 — Impact of Itraconazole on the Pharmacokinetics and Safety of Dazucorilant in Healthy, Adult Participants · Phase 1 · completed
- NCT05772169 — Study to Determine the Prevalence of Hypercortisolism in Patients With Type 2 Diabetes and Treatment With Korlym® (Mifep · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03315338 (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 Corcept Therapeutics
- Last refreshed: 24 May 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/NCT03315338.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing