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

NCT03856970 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2019-07-29

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Ironwood Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Zurab Machaidze, MD · Ironwood Pharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-11
Primary Completion
2019-06-25
Completion
2019-07-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03856970 on ClinicalTrials.gov