drugset / Trial / NCT01568411

A Fixed-Sequence, Two-Period, Open-Label Drug-Drug Interaction Study to Assess the Effect of an Inhibitor of Cytochrome P450 Isoenzyme 3A4 and Permeability Glycoprotein 1 on the Pharmacokinetics of TD-1211

NCT01568411

Phase 1 Completed 20 enrolled Glycyx Therapeutics Theravance Biopharma · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study will examine the effect of an inhibitor of cytochrome P450 isoenzyme 3A4 (CYP3A4) and permeability glycoprotein 1 (P gp) (200 mg itraconazole) on the PK disposition of a 10 mg tablet of TD- 1211 administered orally to fasted subjects.

Timeline

Start
2012-04
Primary completion
2012-06
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Itraconazole Small molecule 200 mg
Comparator axelopran Small molecule 10 mg Oral

Indications

No indication recorded.