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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT03856970

Run by

Ironwood Pharmaceuticals, Inc.

People needed

87

Starts

2019-03-11

Expected to finish

2019-07-03

Last updated by the study team

2019-07-29

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• PPD — Austin, Texas, United States

Full record on ClinicalTrials.gov

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