drugset / Trial / NCT02831972

Drug-Drug Interaction Study of AG120 in Healthy Subjects

NCT02831972

Phase 1 Completed 22 enrolled Agios Pharmaceuticals, Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

An Open-Label, 2-Period, Fixed Sequence Study to Determine the Effect of Multiple Oral Doses of Itraconazole on the Single Dose Pharmacokinetics of AG 120 in Healthy Adult Subjects. Period 1 consists of a single oral dose of AG-120 will be administered at Hour 0 followed by PK sampling for 504 hours (21 days). In Period 2, multiple oral doses of itraconazole will be administered once daily (QD) for 18 consecutive days with a single oral dose of AG-120 coadministered at Hour 0 on Day 1. PK sampling for AG-120 will be taken for 504 hours (21 days) following AG-120 dosing on Day 1.

Timeline

Start
2016-06
Primary completion
2016-09
Completion
2016-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Itraconazole Small molecule Oral
Subject Ivosidenib Small molecule Oral

Indications

No indication recorded.