Healthy Volunteers
Conditions
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.
Interventions
DRUGMicrogestin®
30 μg/1500 μg tablets for oral administration
DRUGLevothyroxine
600 μg tablets for oral administration
DRUGGlyburide
5 mg tablets for oral administration
DRUGDigoxin
0.25 mg tablets for oral administration
DRUGIW-3718
500-mg film-coated tablets for oral administration
Sponsors
Ironwood Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK of Digoxin: t1/2 | Treatment Period 1 (Days 23-30) and Treatment Period 2 (Days 35-42): predose, up to 168 hours postdose |
| PK of Glyburide: Tmax | Treatment Period 1 (Days 1-4) and Treatment Period 2 (Days 11-14): predose, up to 72 hours postdose |
| PK of Digoxin: AUC0-t | Treatment Period 1 (Days 23-30) and Treatment Period 2 (Days 35-42): predose, up to 168 hours postdose |
| PK of Digoxin: AUC0-inf | Treatment Period 1 (Days 23-30) and Treatment Period 2 (Days 35-42): predose, up to 168 hours postdose |
| PK of Digoxin: Cmax | Treatment Period 1 (Days 23-30) and Treatment Period 2 (Days 35-42): predose, up to 168 hours postdose |
| PK of Digoxin: Tmax | Treatment Period 1 (Days 23-30) and Treatment Period 2 (Days 35-42): predose, up to 168 hours postdose |
| PK of EE and NET: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-t) | Treatment Period 1 (Days 1-6) and Treatment Period 2 (Days 14-19): predose, up to 120 hours postdose |
| PK of EE and NET: AUC From Time 0 Extrapolated to Infinity (AUC0-inf) | Treatment Period 1 (Days 1-6) and Treatment Period 2 (Days 14-19): predose, up to 120 hours postdose |
| PK of Glyburide: t1/2 | Treatment Period 1 (Days 1-4) and Treatment Period 2 (Days 11-14): predose, up to 72 hours postdose |
| PK of EE and NET: Maximum Observed Plasma Concentration (Cmax) | Treatment Period 1 (Days 1-6) and Treatment Period 2 (Days 14-19): predose, up to 120 hours postdose |
| PK of EE and NET: Time to Maximum Observed Plasma Concentration (Tmax) | Treatment Period 1 (Days 1-6) and Treatment Period 2 (Days 14-19): predose, up to 120 hours postdose |
| PK of EE and NET: Terminal Phase Half-Life (t1/2) | Treatment Period 1 (Days 1-6) and Treatment Period 2 (Days 14-19): predose, up to 120 hours postdose |
| PK of Levothyroxine: AUC0-t | Treatment Period 1 (Days 1-3) and Treatment Period 2 (Days 39-41): predose, up to 48 hours postdose |
| PK of Levothyroxine: AUC0-inf | Treatment Period 1 (Days 1-3) and Treatment Period 2 (Days 39-41): predose, up to 48 hours postdose |
| PK of Levothyroxine: Cmax | Treatment Period 1 (Days 1-3) and Treatment Period 2 (Days 39-41): predose, up to 48 hours postdose |
| PK of Levothyroxine: Tmax | Treatment Period 1 (Days 1-3) and Treatment Period 2 (Days 39-41): predose, up to 48 hours postdose |
| PK of Levothyroxine: t1/2 | Treatment Period 1 (Days 1-3) and Treatment Period 2 (Days 39-41): predose, up to 48 hours postdose |
| PK of Glyburide: AUC0-t | Treatment Period 1 (Days 1-4) and Treatment Period 2 (Days 11-14): predose, up to 72 hours postdose |
| PK of Glyburide: AUC0-inf | Treatment Period 1 (Days 1-4) and Treatment Period 2 (Days 11-14): predose, up to 72 hours postdose |
| PK of Glyburide: Cmax | Treatment Period 1 (Days 1-4) and Treatment Period 2 (Days 11-14): predose, up to 72 hours postdose |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With ≥1 Clinically Significant Changes in Clinical Laboratory Test Results | Part 1: up to Day 19; Part 2: up to Day 41; Part 3: up to Day 42 |
| Number of Participants With ≥1 Clinically Significant Changes in Vital Sign Measurements | Part 1: up to Day 19; Part 2: up to Day 41; Part 3: up to Day 42 |
| Number of Participants With ≥1 Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Results | Part 1: up to Day 19; Part 2: up to Day 41; Part 3: up to Day 42 |
| Number of Participants With ≥1 Clinically Significant Changes in Physical Examination Findings | Part 1: up to Day 19; Part 2: up to Day 41; Part 3: up to Day 42 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations due to TEAEs | Part 1: up to Day 27 (±1 day); Part 2: up to Day 49 (±1 day); Part 3: Day 50 (±1 day) |
Countries
United States
Outcome results
None listed