Clinical trial NCT07013643: A Study to Assess the Impact of Multiple Doses of AZD6234 on a Single Dose of Combined Oral Contraceptive in Female Participants
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Obesity
Overweight
Oral contraceptives
Pharmacokinetics
Drug Interaction
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2025-06-10
Enrollment: 25
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Area under the concentration-time curve from time 0 to infinity (AUCinf) of EE and LEVO
timeFrame: At predefined intervals from Day -5 up to Day 99
measure: Area under the concentration-time curve from time of dosing to the last measurable concentration (AUClast) of EE and LEVO
timeFrame: At predefined intervals from Day -5 up to Day 99
measure: Maximum plasma concentration (Cmax) of EE and LEVO
timeFrame: At predefined intervals from Day -5 up to Day 99
measure: Time to reach maximum drug concentration in plasma (tmax) of EE and LEVO
timeFrame: At predefined intervals from Day -5 up to Day 99
measure: Elimination half-life (t1/2λz) for EE and LEVO
timeFrame: At predefined intervals from Day -5 up to Day 99
measure: Area under the concentration-time curve for a defined interval between doses (AUCtau) of AZD6234
timeFrame: At predefined intervals from Day 1 to Day 92
measure: AUClast of AZD6234
timeFrame: At predefined intervals from Day 1 to Day 92
measure: Cmax of AZD6234
timeFrame: At predefined intervals from Day 1 to Day 92
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to Day 120
measure: Number of participants developing detectable anti-drug antibodies (ADAs) against AZD6234
timeFrame: At predefined intervals from Day -2 up to Day 120
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Research Site
state: California
city: Brooklyn
country: United States
facility: Research Site
state: Maryland
Study officials:
References: