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

• Status: Completed
• Trial end date: 2019-07-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ironwood Pharmaceuticals, Inc.
• Treatments: Contraceptive Agents; Contraceptives, Oral; Digoxin; Estradiol; Ethinyl Estradiol; Glyburide; Norethindrone

Criteria

Inclusion Criteria:

• Is healthy, ambulatory, and 18-50 years of age (inclusive) at screening visit.

• Weighs at least 50 kg and has a body mass index within 18-35 kg/m2 at the screening visit.

• Is not pregnant or breastfeeding at the time of the screening visit and has negative serum pregnancy tests at the screening visit and check-in.

• Other inclusion criteria per protocol.

Exclusion Criteria:

• Has used any prescription drugs, herbal supplements, over-the-counter medication, or dietary supplements (vitamins included) within 4 weeks prior to dosing. If needed, (ie, incidental and limited need), acetaminophen is acceptable.

• Has consumed grapefruit or grapefruit juice within 4 weeks prior to dosing or plans to consume grapefruit or grapefruit juice before 7 days following the last dose.

• Has a significant illness that has not resolved within 2 weeks prior to dosing.

• Has a history of immunodeficiency diseases, including a positive human immunodeficiency virus test result.

• Has a positive hepatitis B surface antigen or hepatitis C antibody test result.

• Is a smoker or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 6 months before the first dose of study drug.

• Other exclusion criteria per protocol.