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Microgestin®

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

Ensayo de IRONWOOD PHARMACEUTICALS INC en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

87

previstos

Centros

1

Fin del objetivo primario

jun 2019

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en mar 2019.

Qué mide

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) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe 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.

Más ensayos de IRWD

Todos los de IRWD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03856970), actualizada en jul 2019.