drugset
drugset / Trial / NCT03856970

Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers

NCT03856970 ↗

Phase 1 Completed 87 enrolled Ironwood Pharmaceuticals, Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The primary objectives of this study are the following: * To evaluate the pharmacokinetics (PK) of a monophasic oral contraceptive's active components, ethinyl estradiol (EE) and norethindrone acetate (NET), following a single oral dose alone and in combination with IW-3718 in healthy adult female participants. * To evaluate the PK of levothyroxine following a single oral dose alone and in combination with IW-3718 in healthy adult participants. * To evaluate the PK of glyburide following a single oral dose alone and in combination with IW-3718 in healthy adult participants. * To evaluate the PK of digoxin following a single oral dose alone and in combination with IW-3718 in healthy adult participants.

Timeline

Start
2019-03-11
Primary completion
2019-06-25
Completion
2019-07-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Colesevelam Other / unclassified 1500 mg Oral
Subject Digoxin Other / unclassified 0.25 mg Oral
Subject Glyburide Small molecule 5 mg Oral
Subject Levothyroxine Other / unclassified 600 ug Oral
Subject Norethindrone Unknown 1500 ug Oral
Subject ethinyl estradiol Small molecule 30 ug Oral

Indications

No indication recorded.