drugset / Trial / NCT03072056

A Pharmacokinetic Study of MIN-101 and Its Metabolites in Healthy Subjects to Compare MIN-101 in Poor and Extensive Metabolizers

NCT03072056

Phase 1 Completed 23 enrolled Minerva Neurosciences
Non-randomizedCrossoverOpen-labelOther

Summary

* To evaluate the pharmacokinetic (PK) profile of MIN-101 and its metabolites in extensive (EM) and poor (PM) metabolizers * To evaluate the relationship between plasma levels of MIN-101 and changes in QT/QTcF intervals * To evaluate safety and tolerability of MIN-101.

Timeline

Start
2017-01-09
Primary completion
2017-07-07
Completion
2017-07-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Roluperidone Small molecule 4 mg Oral
Subject Roluperidone Small molecule 8 mg Oral
Subject Roluperidone Small molecule 16 mg Oral

Indications

No indication recorded.