drugset / Trial / NCT02804178

A Study of ATR-101 for the Treatment of Congenital Adrenal Hyperplasia

NCT02804178 ↗

Phase 2 Completed 10 enrolled Millendo Therapeutics, Inc.
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

EvaluationDrugModalityDoseRoute
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