Tildacerfont for Adrenocortical Hyperfunction

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Adrenocortical Hyperfunction+5 More
Tildacerfont - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial looks at whether the drug Tildacerfont is safe for children with Congenital Adrenal Hyperplasia.

Eligible Conditions
  • Adrenocortical Hyperfunction
  • Congenital adrenal hyperplasia
  • 21-OHD

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 14 days

14 days
Acceptability assessed using a 5-point hedonic scale following dosing
Area under the plasma concentration versus time curve (AUC)
Number of subjects with TEAE as assessed by CTAE version 5
Palatability (smell taste, texture) assessed using a 5-point hedonic scale following dosing

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

Cohort 1: Age 11-17 Treatment with Tildacerfont
1 of 3
Cohort 3: Age 6-10 Treatment with Tildacerfont
1 of 3
Cohort 2: Age 11-17 Treatment with Tildacerfont
1 of 3

Experimental Treatment

20 Total Participants · 3 Treatment Groups

Primary Treatment: Tildacerfont · No Placebo Group · Phase 2

Cohort 1: Age 11-17 Treatment with Tildacerfont
Drug
Experimental Group · 1 Intervention: Tildacerfont · Intervention Types: Drug
Cohort 3: Age 6-10 Treatment with Tildacerfont
Drug
Experimental Group · 1 Intervention: Tildacerfont · Intervention Types: Drug
Cohort 2: Age 11-17 Treatment with Tildacerfont
Drug
Experimental Group · 1 Intervention: Tildacerfont · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 14 days

Who is running the clinical trial?

Spruce BiosciencesLead Sponsor
5 Previous Clinical Trials
238 Total Patients Enrolled
4 Trials studying Adrenocortical Hyperfunction
199 Patients Enrolled for Adrenocortical Hyperfunction
Will Charlton, MDStudy DirectorSpruce Biosciences
5 Previous Clinical Trials
622 Total Patients Enrolled
Dennis AguilingStudy DirectorDirector of Clinical Operations

Eligibility Criteria

Age < 18 · All Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 31st, 2021

Last Reviewed: November 25th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.