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The primary objectives of this study are the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Healthy Volunteers | Experimental | 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). |
|
| Part 2: Healthy Volunteers | Experimental | 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). |
|
| Part 3: Healthy Volunteers | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microgestin® | Drug | 30 μg/1500 μg tablets for oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | |
| Number of Participants With ≥1 Clinically Significant Changes in Clinical Laboratory Test Results |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zurab Machaidze, MD | Ironwood Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD | Austin | Texas | 78744 | United States |
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| Levothyroxine | Drug | 600 μg tablets for oral administration |
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| 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 |
|
| 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 |
| 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 Glyburide: t1/2 | 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 Digoxin: t1/2 | Treatment Period 1 (Days 23-30) and Treatment Period 2 (Days 35-42): predose, up to 168 hours postdose |
| 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 |
| ID | Term |
|---|---|
| D004997 | Ethinyl Estradiol |
| D009640 | Norethindrone |
| D013974 | Thyroxine |
| D005905 | Glyburide |
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009652 | Norpregnenes |
| D013963 | Thyroid Hormones |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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