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

Phase 1

Recruiting

• Conditions: Healthy Participants
• Interventions: Drug: AZD6234; Drug: Ethinyl estradiol/Levonorgestrel (EE/LEVO); Drug: Acetaminophen (APAP)

• Registration Number: NCT07013643
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

This is a Phase I, open-label, single-sequence, single-cohort study which will be performed at multiple study sites in healthy females of childbearing and non-childbearing potential.

The purpose of this study is to investigate the effect of AZD6234 on the pharmacokinetics (PK: the way the body absorbs, distributes, metabolizes, and eliminates a medicine), safety and tolerability of AZD6234 with combined oral contraceptive, ethinyl estradiol/levonorgestrel (EE/LEVO).

The study will consist of 5 periods which include, Screening, Start, Up-titration, Maintenance, and Follow-up periods.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-02
• Study First Submitted QC: 2025-06-02
• Study Start: 2025-06-04
• Study First Posted: 2025-06-10
• Last Update Submitted: 2025-06-17
• Last Update Posted: 2025-06-22
• Primary Completion: 2026-01-07
• Study Completion: 2026-01-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
AZD6234 + EE/LEVO + Acetaminophen (APAP)	AZD6234	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.
AZD6234 + EE/LEVO + Acetaminophen (APAP)	Ethinyl estradiol/Levonorgestrel (EE/LEVO)	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.
AZD6234 + EE/LEVO + Acetaminophen (APAP)	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.

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve from time 0 to infinity (AUCinf) of EE and LEVO	At predefined intervals from Day -5 up to Day 99	To assess the effect of multiple doses of AZD6234 on the PK of single doses of combined oral contraceptive EE/LEVO.
Area under the concentration-time curve from time of dosing to the last measurable concentration (AUClast) of EE and LEVO	At predefined intervals from Day -5 up to Day 99	To assess the effect of multiple doses of AZD6234 on the PK of single doses of combined oral contraceptive EE/LEVO .
Maximum plasma concentration (Cmax) of EE and LEVO	At predefined intervals from Day -5 up to Day 99	To assess the effect of multiple doses of AZD6234 on the PK of single doses of combined oral contraceptive EE/LEVO.
Time to reach maximum drug concentration in plasma (tmax) of EE and LEVO	At predefined intervals from Day -5 up to Day 99	To assess the effect of multiple doses of AZD6234 on the PK of single doses of combined oral contraceptive EE/LEVO.
Area under the concentration-time curve for a defined interval between doses (AUCtau) of AZD6234	At predefined intervals from Day 1 to Day 92	To assess the effect of multiple doses of AZD6234 on the PK of single doses of combined oral contraceptive EE/LEVO
AUClast of AZD6234	At predefined intervals from Day 1 to Day 92	To assess the effect of multiple doses of AZD6234 on the PK of single doses of combined oral contraceptive EE/LEVO.
Cmax of AZD6234	At predefined intervals from Day 1 to Day 92	To assess the effect of multiple doses of AZD6234 on the PK of single doses of combined oral contraceptive EE/LEVO.
Elimination half-life (t1/2λz) for EE and LEVO	At predefined intervals from Day -5 up to Day 99	To assess the effect of multiple doses of AZD6234 on the PK of single doses of combined oral contraceptive EE/LEVO.

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events (AEs)	Up to Day 120	To assess the safety and tolerability of AZD6234 with combined oral contraceptive EE/LEVO.
Number of participants developing detectable anti-drug antibodies (ADAs) against AZD6234	At predefined intervals from Day -2 up to Day 120	To assess the safety and tolerability of AZD6234 with combined oral contraceptive EE/LEVO.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Brooklyn, Maryland, United States