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

Study identifier:D8750C00006

ClinicalTrials.gov identifier:NCT07013643

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

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

Medical condition

Healthy Participants

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD6234, Ethinyl estradiol/Levonorgestrel (EE/LEVO), Acetaminophen (APAP)

Sex

Female

Estimated Enrollment

Study type

Interventional

Age

35 Years - 75 Years

Date

Study Start Date: 04 Jun 2025

Estimated Primary Completion Date: 07 Jan 2026

Estimated Study Completion Date: 07 Jan 2026

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2025 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion 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.
o Hormonal contraceptives and estrogen-containing hormonal methods of birth control are not permitted due to potential effect and influence on the results using a combined oral contraceptive assessment.
• 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.

Exclusion Criteria

• 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.

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No locations available

Arms	Assigned Interventions
Experimental: AZD6234 + EE/LEVO + Acetaminophen (APAP) All participants will receive combined oral contraceptive (EE/LEVO) and, separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous AZD6234 administration.	-

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]