RECRUITING

A Study to Investigate the Effect of AZD6234 and a Combination of AZD9550 and AZD6234 on Pharmacokinetics of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity

Conditions

Healthy Participants Obesity Overweight Oral contraceptives Pharmacokinetics Drug Interaction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will measure the effects of multiple doses of AZD6234 and a combination of AZD6234 and AZD9550 given as injection(s) on pharmacokinetics (PK) of combined oral contraceptive ethinyl estradiol (EE)/levonorgestrel (LEVO) in healthy female participants with obesity.

Official Title

An Open-label, Single-sequence Multiple Cohort Study to Assess the Effect of Multiple Doses of AZD6234 and a Combination of AZD9550 and AZD6234 on the Pharmacokinetics of Single Doses of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity

Quick Facts

Study Start:2025-06-04

Study Completion:2026-01-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07013643

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.

Ages Eligible for Study:35 Years to 75 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* All participants must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit. * Females 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, venous thromboembolism, 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 of neoplastic disease, basal calcitonin level \>50 ng/L (50 pg/L) at screening (Cohort 2), history of acute or chronic pancreatitis or pancreatic amylase or lipase \>2×ULN at screening (cohort 2), prior history of cholecystectomy or untreated cholelithiasis and personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia type 2 (MEN2) (cohort 2)). * 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.

Inclusion Criteria

Exclusion Criteria

* All participants must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
* Females 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, venous thromboembolism, 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 of neoplastic disease, basal calcitonin level \>50 ng/L (50 pg/L) at screening (Cohort 2), history of acute or chronic pancreatitis or pancreatic amylase or lipase \>2×ULN at screening (cohort 2), prior history of cholecystectomy or untreated cholelithiasis and personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia type 2 (MEN2) (cohort 2)).
* 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.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479

information.center@astrazeneca.com

Study Locations (Sites)

Research Site

Glendale, California, 91206

United States

Research Site

Brooklyn, Maryland, 21225

United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-04

Study Completion Date2026-01-07

Study Record Updates

Study Start Date2025-06-04

Study Completion Date2026-01-07

Terms related to this study

Keywords Provided by Researchers

Obesity
Overweight
Oral contraceptives
Pharmacokinetics
Drug Interaction

Additional Relevant MeSH Terms

Healthy Participants