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Completed

NCT Number: NCT03856970

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Microgestin®

Drug

30 μg/1500 μg tablets for oral administration

Other names: ethinyl estradiol 30 μg and norethindrone 1500 μg

Levothyroxine

Drug

600 μg tablets for oral administration

Glyburide

Drug

5 mg tablets for oral administration

Digoxin

Drug

0.25 mg tablets for oral administration

IW-3718

Drug

500-mg film-coated tablets for oral administration

Primary outcomes

  1. PK of EE and NET: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-t)

    Time frame: Treatment Period 1 (Days 1-6) and Treatment Period 2 (Days 14-19): predose, up to 120 hours postdose

  2. PK of EE and NET: AUC From Time 0 Extrapolated to Infinity (AUC0-inf)

    Time frame: Treatment Period 1 (Days 1-6) and Treatment Period 2 (Days 14-19): predose, up to 120 hours postdose

  3. PK of EE and NET: Maximum Observed Plasma Concentration (Cmax)

    Time frame: Treatment Period 1 (Days 1-6) and Treatment Period 2 (Days 14-19): predose, up to 120 hours postdose

  4. PK of EE and NET: Time to Maximum Observed Plasma Concentration (Tmax)

    Time frame: Treatment Period 1 (Days 1-6) and Treatment Period 2 (Days 14-19): predose, up to 120 hours postdose

  5. PK of EE and NET: Terminal Phase Half-Life (t1/2)

    Time frame: Treatment Period 1 (Days 1-6) and Treatment Period 2 (Days 14-19): predose, up to 120 hours postdose

  6. PK of Levothyroxine: AUC0-t

    Time frame: Treatment Period 1 (Days 1-3) and Treatment Period 2 (Days 39-41): predose, up to 48 hours postdose

  7. PK of Levothyroxine: AUC0-inf

    Time frame: Treatment Period 1 (Days 1-3) and Treatment Period 2 (Days 39-41): predose, up to 48 hours postdose

  8. PK of Levothyroxine: Cmax

    Time frame: Treatment Period 1 (Days 1-3) and Treatment Period 2 (Days 39-41): predose, up to 48 hours postdose

  9. PK of Levothyroxine: Tmax

    Time frame: Treatment Period 1 (Days 1-3) and Treatment Period 2 (Days 39-41): predose, up to 48 hours postdose

  10. PK of Levothyroxine: t1/2

    Time frame: Treatment Period 1 (Days 1-3) and Treatment Period 2 (Days 39-41): predose, up to 48 hours postdose

  11. PK of Glyburide: AUC0-t

    Time frame: Treatment Period 1 (Days 1-4) and Treatment Period 2 (Days 11-14): predose, up to 72 hours postdose

  12. PK of Glyburide: AUC0-inf

    Time frame: Treatment Period 1 (Days 1-4) and Treatment Period 2 (Days 11-14): predose, up to 72 hours postdose

  13. PK of Glyburide: Cmax

    Time frame: Treatment Period 1 (Days 1-4) and Treatment Period 2 (Days 11-14): predose, up to 72 hours postdose

  14. PK of Glyburide: Tmax

    Time frame: Treatment Period 1 (Days 1-4) and Treatment Period 2 (Days 11-14): predose, up to 72 hours postdose

  15. PK of Glyburide: t1/2

    Time frame: Treatment Period 1 (Days 1-4) and Treatment Period 2 (Days 11-14): predose, up to 72 hours postdose

  16. PK of Digoxin: AUC0-t

    Time frame: Treatment Period 1 (Days 23-30) and Treatment Period 2 (Days 35-42): predose, up to 168 hours postdose

  17. PK of Digoxin: AUC0-inf

    Time frame: Treatment Period 1 (Days 23-30) and Treatment Period 2 (Days 35-42): predose, up to 168 hours postdose

  18. PK of Digoxin: Cmax

    Time frame: Treatment Period 1 (Days 23-30) and Treatment Period 2 (Days 35-42): predose, up to 168 hours postdose

  19. PK of Digoxin: Tmax

    Time frame: Treatment Period 1 (Days 23-30) and Treatment Period 2 (Days 35-42): predose, up to 168 hours postdose

  20. PK of Digoxin: t1/2

    Time frame: Treatment Period 1 (Days 23-30) and Treatment Period 2 (Days 35-42): predose, up to 168 hours postdose

Secondary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations due to TEAEs

    Time frame: Part 1: up to Day 27 (±1 day); Part 2: up to Day 49 (±1 day); Part 3: Day 50 (±1 day)

  2. Number of Participants With ≥1 Clinically Significant Changes in Clinical Laboratory Test Results

    Time frame: Part 1: up to Day 19; Part 2: up to Day 41; Part 3: up to Day 42

  3. Number of Participants With ≥1 Clinically Significant Changes in Vital Sign Measurements

    Time frame: Part 1: up to Day 19; Part 2: up to Day 41; Part 3: up to Day 42

  4. Number of Participants With ≥1 Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Results

    Time frame: Part 1: up to Day 19; Part 2: up to Day 41; Part 3: up to Day 42

  5. Number of Participants With ≥1 Clinically Significant Changes in Physical Examination Findings

    Time frame: Part 1: up to Day 19; Part 2: up to Day 41; Part 3: up to Day 42

Sponsors and collaborators

Lead sponsor

Ironwood Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Phase 1, Open-Label, Parallel, Sequential, Multi-part Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of an Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 27, 2019
Registry last updated
Jul 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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