drugset / Trial / NCT03540836

A Study to Determine the Relative Bioavailability of Two New Relacorilant Capsule Variants

NCT03540836

Phase 1 Completed 30 enrolled Corcept Therapeutics
RandomizedCrossoverOpen-labelOther

Summary

This is an open-label, randomized, 3 treatment, 3-period, 6-sequence, crossover study conducted at a single study center to characterize the relative bioavailability of relacorilant administered as 3×100-mg softgel capsules (Treatment A), 3×100 mg hard-shell capsules (Treatment B), and 6×50-mg hard shell capsules (Treatment C/reference) in healthy, fasted, adult subjects. Eligible subjects will participate in 3 treatment periods. During each treatment period, subjects will receive a single 300-mg relacorilant dose. An equal number of subjects will be randomized to each of 6 sequences.

Timeline

Start
2018-05-24
Primary completion
2018-07-16
Completion
2018-07-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Relacorilant Small molecule 300 mg

Indications

No indication recorded.