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

AstraZeneca

Status and phase: Enrolling; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Ethinyl estradiol/Levonorgestrel (EE/LEVO); Drug: AZD6234; Drug: Acetaminophen (APAP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07013643

D8750C00006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: Female

Ages: 35 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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25 participants in 1 patient group

AZD6234 + EE/LEVO + Acetaminophen (APAP)

Experimental group

Description:

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.

Treatment:

Drug: Acetaminophen (APAP)

Drug: AZD6234

Drug: Ethinyl estradiol/Levonorgestrel (EE/LEVO)