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

NCT ID: NCT03856970

Last Updated: 2019-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-11
• Study Completion Date: 2019-07-03

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 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1: Healthy Volunteers

Microgestin® (EE 30 μg and NET 1500 μg) single dose (Day 1). After a 10-14 day washout, Microgestin® single dose (Day 14) PLUS IW-3718 1500 mg twice daily (Days 13 to 19).

Group Type: EXPERIMENTAL

Microgestin®

Intervention Type: DRUG

30 μg/1500 μg tablets for oral administration

IW-3718

Intervention Type: DRUG

500-mg film-coated tablets for oral administration

Part 2: Healthy Volunteers

Levothyroxine 600 μg single dose (Day 1). After a 35-39 day washout, levothyroxine 600 μg single dose (Day 39) PLUS IW-3718 1500 mg twice daily (Days 38 to 41).

Group Type: EXPERIMENTAL

Levothyroxine

Intervention Type: DRUG

600 μg tablets for oral administration

IW-3718

Intervention Type: DRUG

500-mg film-coated tablets for oral administration

Part 3: Healthy Volunteers

Phase 1: Glyburide 5 mg single dose (Day 1). After a 7-10 day washout, glyburide 5 mg single dose (Day 11) PLUS IW-3718 1500 mg twice daily (ie, Days 10 to 14).

Phase 2: Digoxin 0.25 mg single dose (Day 23). After a 10-14 day washout, digoxin 0.25 mg mg single dose (Day 35) PLUS IW-3718 1500 mg twice daily (Days 34 to 42).

Group Type: EXPERIMENTAL

Glyburide

Intervention Type: DRUG

5 mg tablets for oral administration

Digoxin

Intervention Type: DRUG

0.25 mg tablets for oral administration

IW-3718

Intervention Type: DRUG

500-mg film-coated tablets for oral administration

Interventions

Microgestin®

30 μg/1500 μg tablets for oral administration

Intervention Type: DRUG

Levothyroxine

600 μg tablets for oral administration

Intervention Type: DRUG

Glyburide

5 mg tablets for oral administration

Intervention Type: DRUG

Digoxin

0.25 mg tablets for oral administration

Intervention Type: DRUG

IW-3718

500-mg film-coated tablets for oral administration

Intervention Type: DRUG

Other Intervention Names

ethinyl estradiol 30 μg and norethindrone 1500 μg

Eligibility 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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ironwood Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zurab Machaidze, MD

Role: STUDY_DIRECTOR

Ironwood Pharmaceuticals, Inc.

Locations

PPD

Austin, Texas, United States

Countries

United States

Other Identifiers

C3718-103

Identifier Type: -

Identifier Source: org_study_id