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Microgestin

Phase 1

Healthy Volunteers | Small molecule | Other |Ironwood Pharmaceuticals, Inc.|Last Updated: Jul 29, 2019

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment87

FDA Designations

No designations recorded

Clinical trial landscape

Microgestin · 1 trial · 1 indication

Phase 1 1
NCT03856970Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult VolunteersHealthy Volunteers
COMPLETED87 Analytics
PHASE1COMPLETED
Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers
Healthy Volunteers
NCT0385697087
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Study Endpoints

Primary Endpoints

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
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

Secondary Endpoints

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
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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: Healthy VolunteersEXPERIMENTALMicrogestin® (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 VolunteersEXPERIMENTALLevothyroxine 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 VolunteersEXPERIMENTALPhase 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).

Interventions

NameTypeDescription
Microgestin®DRUG30 μg/1500 μg tablets for oral administration
LevothyroxineDRUG600 μg tablets for oral administration
GlyburideDRUG5 mg tablets for oral administration
DigoxinDRUG0.25 mg tablets for oral administration
IW-3718DRUG500-mg film-coated tablets for oral administration
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 te...

Countries:United States
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Frequently asked questions about Microgestin

What is Microgestin?

Microgestin is a small molecule drug being developed by Ironwood Pharmaceuticals, Inc. (IRWD). It is currently in Phase 1 clinical development for use in healthy volunteers. Microgestin is an investigational drug and has not been approved by the FDA.

What is Microgestin used for?

Microgestin is being studied for use in healthy volunteers. The clinical trial for Microgestin is designed to evaluate its effect on the pharmacokinetics of other drugs, including an oral contraceptive, levothyroxine, glyburide, and digoxin, in healthy adult volunteers.

Who makes Microgestin?

Microgestin is being developed by Ironwood Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IRWD. The company is conducting clinical research on Microgestin as an investigational small molecule drug.

What phase is Microgestin in?

Microgestin is in Phase 1 clinical development. It is an investigational drug and is not FDA approved. The Phase 1 trial for Microgestin has been completed, and the drug remains in early-stage clinical development.

What clinical trials is Microgestin in?

Microgestin has one completed Phase 1 clinical trial, identified as NCT03856970. This study evaluated the effect of Microgestin on the pharmacokinetics of an oral contraceptive, levothyroxine, glyburide, and digoxin in healthy adult volunteers. The trial enrolled 87 participants in the United States.

Is Microgestin the same as IW-3718?

Microgestin is the drug name used in the clinical trial NCT03856970, which is titled 'Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers.' The trial evaluates the drug IW-3718, which is referred to as Microgestin in this context.