NCT03856970

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

A Phase 1, Open-Label, Parallel, Sequential, Multi-part Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of an Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Ironwood Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Microgestin®	30 μg/1500 μg tablets for oral administration
DRUG	Levothyroxine	600 μg tablets for oral administration
DRUG	Glyburide	5 mg tablets for oral administration
DRUG	Digoxin	0.25 mg tablets for oral administration
DRUG	IW-3718	500-mg film-coated tablets for oral administration

Timeline

• Start date: 2019-03-11
• Primary completion: 2019-06-25
• Completion: 2019-07-03
• First posted: 2019-02-27
• Last updated: 2019-07-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study