drugset / Trial / NCT02804178
A Study of ATR-101 for the Treatment of Congenital Adrenal Hyperplasia
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase 2 multicenter, single-blind, multiple dose study to evaluate the safety and efficacy of orally administered ATR-101 in subjects with classic congenital adrenal hyperplasia (CAH). Treatment duration will range from a minimum of approximately 2 months to 6 months per subject. A subject may receive a minimum of one dose level or up to a maximum of 5 dose levels, in sequentially increasing dose strengths. Each dose level will last 28 days.
Timeline
- Start
- 2016-05-18
- Primary completion
- 2017-08-17
- Completion
- 2017-08-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nevanimibe | Small molecule | 125 mg | Oral |
| Subject | Nevanimibe | Small molecule | 250 mg | Oral |
| Subject | Nevanimibe | Small molecule | 500 mg | Oral |
| Subject | Nevanimibe | Small molecule | 750 mg | Oral |
| Subject | Nevanimibe | Small molecule | 1000 mg | Oral |