RECRUITING

A Study to Assess the Impact of Multiple Doses of AZD6234 on a Single Dose of Combined Oral Contraceptive in Female Participants

Description

This study will assess the effect of multiple doses of AZD6234 on the effect of single doses of combined oral contraceptive ethinyl estradiol (EE)/levonorgestrel (LEVO) in healthy female participants with overweight or obesity.

Study Overview

Study Details

Study overview

This study will assess the effect of multiple doses of AZD6234 on the effect of single doses of combined oral contraceptive ethinyl estradiol (EE)/levonorgestrel (LEVO) in healthy female participants with overweight or obesity.

An Open-Label, Single-Sequence Study to Assess the Effect of Multiple Doses of AZD6234 on the Pharmacokinetics of Single Doses of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity

A Study to Assess the Impact of Multiple Doses of AZD6234 on a Single Dose of Combined Oral Contraceptive in Female Participants

Condition
Healthy Participants
Intervention / Treatment

-

Contacts and Locations

Glendale

Research Site, Glendale, California, United States, 91206

Brooklyn

Research Site, Brooklyn, Maryland, United States, 21225

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * All participants must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
  • * Women of childbearing potential must not be lactating and if heterosexually active, must agree to use an approved method of highly effective contraception.
  • * Females of non-childbearing potential must be confirmed at the Screening Visit.
  • * Have a Body Mass Index (BMI) ≥ 25 kg/m2 inclusive and weigh at least 60 kg.
  • * History of any clinically important disease or disorder (gastroparesis, deep vein thrombosis, previous surgery of the upper gastrointestinal tract, cardiovascular disease, neuromuscular or neurogenic disease, severe vitamin D deficiency, type I or type II diabetes mellitus, glycated hemoglobin (HbA1c) ≥ 6.5%) at screening.
  • * History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
  • * Any clinically important illness, medical/surgical procedure, or trauma.
  • * Any laboratory values with deviations or clinically important abnormalities in clinical chemistry, hematology, or urinalysis.
  • * Any positive result on screening for serum Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb) or Human immunodeficiency virus (HIV).
  • * Abnormal vital signs.
  • * Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12 lead electrocardiogram (ECG), at screening.
  • * Current smokers or those who have smoked or used nicotine products.
  • * Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
  • * History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
  • * Statin treatment within 4 weeks prior to the start of study treatment.
  • * Current use of estrogen-containing products.

Ages Eligible for Study

35 Years to 75 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2026-01-07