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NCT06495944 · ClinicalTrials.gov registry record · Phase 1
Impact of Itraconazole on the Pharmacokinetics and Safety of Dazucorilant in Healthy, Adult Participants
A Phase 1 study of Healthy Adults, sponsored by Corcept Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT06495944 is a Phase 1 study of Healthy Adults that has completed, run by Corcept Therapeutics. The registered enrollment target is 21 participants, below the 86-participant average among 33 other Healthy Adults trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06495944, a Phase 1 study of Healthy Adults, has completed, sponsored by Corcept Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
This study aims to answer how repeat doses of itraconazole impact the pharmacokinetics, safety, and tolerability of single doses of dazucorilant in healthy adults. Participants in this study will complete screening assessments within 28 days before the first dose of study drug. Those participants who can participate will be admitted to the clinical pharmacology center (CPC) and complete pretreatment tests. Those participants will stay at the CPC for the duration of the study. On Days 1 and 8, each participant will receive a single oral dose of dazucorilant 300 mg, after eating. On Days 5-11, all participants will receive once daily, oral doses of itraconazole 200 mg, after eating. Blood and safety assessments will continue for 96-hours after dosing on Day 1 and Day 8. Participants will leave the CPC following completion of all procedures on Day 12. Participants will return to the CPC for a final visit 7 (±1) days after their final dose of study medication.
Conditions Studied
Interventions
- DRUG Itraconazole
- DRUG Dazucorilant
Study Locations (1)
Maryland
- Site 01 - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2024-05-31 |
| Est. Completion | 2024-08-02 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06495944
The ClinicalTrials.gov registry entry for NCT06495944 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 86-participant average among 33 other Healthy Adults trials with a reported enrollment target (76% lower). The listed sponsor is Corcept Therapeutics, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy Adults appearing as the primary indexed condition, and to 2 interventions - of which Itraconazole is the first listed.
NCT06495944 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06495944 about?
NCT06495944 is a clinical study titled "Impact of Itraconazole on the Pharmacokinetics and Safety of Dazucorilant in Healthy, Adult Participants". This study aims to answer how repeat doses of itraconazole impact the pharmacokinetics, safety, and tolerability of single doses of dazucorilant in healthy adults. Participants in this study will complete screening assessments within 28 days before the first dose of study drug. Those participants w...
What is the current status of trial NCT06495944?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2024-05-31. Estimated completion is 2024-08-02.
What conditions does trial NCT06495944 study?
This clinical trial studies the following conditions: Healthy Adults.
What interventions are being tested in trial NCT06495944?
The interventions under investigation include: Itraconazole (DRUG), Dazucorilant (DRUG).
Who is sponsoring clinical trial NCT06495944?
This trial is sponsored by Corcept Therapeutics, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06495944 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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