A Study of the Effect of Tirzepatide on How the Body Handles Birth Control Pills in Healthy Female Participants

Effect of Tirzepatide on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

Patrocinadores

Patrocinador principal: Eli Lilly and Company

Fuente Eli Lilly and Company
Resumen breve

The purpose of this study is to look at how the body processes the commonly prescribed birth control pill, ethinylestradiol + norgestimate (EE/NGM), in healthy female participants and the effect of tirzepatide on how EE/NGM is processed by the body. Information about any side effects that may occur will also be collected.

Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 20 weeks, including screening.

Estado general Recruiting
Fecha de inicio February 26, 2020
Fecha de Terminación February 11, 2021
Fecha de finalización primaria December 18, 2020
Fase Phase 1
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC[0-tau]) of Ethinylestradiol (EE) Periods 1 and 2 on Day 21: Pre-dose through 24 hours post-dose
PK: Maximum Concentration (Cmax) of EE Periods 1 and 2 on Day 21: Pre-dose through 48 hours post-dose
PK: AUC(0-tau) of Norelgestromin (NGMN) Periods 1 and 2 on Day 21: Pre-dose through 24 hours post-dose
PK: Cmax of Norelgestromin (NGMN) Periods 1 and 2 on Day 21: Pre-dose through 48 hours post-dose
Inscripción 42
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Tirzepatide

Descripción: Administered SC

Etiqueta de grupo de brazo: EE/NGM + Tirzepatide (Period 2)

Otro nombre: LY3298176

Tipo de intervención: Drug

Nombre de intervención: EE/NGM

Descripción: Combination oral contraceptive administered orally

Elegibilidad

Criterios:

Inclusion Criteria:

- Overtly healthy females as determined by medical history, physical examination, and other screening procedures

- Have a body mass index (BMI) equal to or above 18.5 kilograms per meter squared (kg/m²), at screening

- Are not intending to start a family within 2 months after the study

Exclusion Criteria:

- Have known allergies to either tirzepatide or ethinylestradiol or norgestimate or related compounds

- Have a medical condition or medical history that precludes the taking of combined oral contraceptives

- Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase or gastrointestinal (GI) disorder (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors

- Have used hormonal implants or received hormonal injections in the past 12 months

- Unwilling to comply with smoking restrictions during the study

- Is a known user of drugs of abuse

Género: Female

Edad mínima: 18 Years

Edad máxima: 45 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company
Contacto general

Apellido: This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Teléfono: 1-317-615-4559

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Investigador: Covance 469-513-6727 Jeanelle Kam Principal Investigator
Ubicacion Paises

United States

Fecha de verificación

July 1, 2020

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Número de brazos 2
Grupo de brazo

Etiqueta: Ethinyl Estradiol + Norgestimate (EE/NGM) Alone (Period 1)

Tipo: Experimental

Descripción: EE and NGM (active tablets) administered orally for 21 days, then non-active tablets administered orally for 7 days. (1 course of oral contraceptive = 28 days.)

Etiqueta: EE/NGM + Tirzepatide (Period 2)

Tipo: Experimental

Descripción: EE and NGM (active tablets) administered orally for 21 days, then non-active tablets administered orally for 7 days. (1 course of oral contraceptive = 28 days.) Tirzepatide administered by subcutaneous injection (SC).

Datos del paciente No
Información de diseño del estudio

Asignación: Non-Randomized

Modelo de intervención: Single Group Assignment

Propósito primario: Basic Science

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov