Status:
COMPLETED
Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers
Lead Sponsor:
Ironwood Pharmaceuticals, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief 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 acetat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 3 2019
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT03856970
Start Date
March 11 2019
End Date
July 3 2019
Last Update
July 29 2019
Active Locations (1)
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1
PPD
Austin, Texas, United States, 78744