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Recruiting Phase 1 NCT07013643

A Study to Investigate the Effect of AZD6234, AZD9550, 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

Trial Parameters

Condition Healthy Participants
Sponsor AstraZeneca
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 75
Sex FEMALE
Min Age 35 Years
Max Age 75 Years
Start Date 2025-06-04
Completion 2026-12-25
Interventions
AZD6234Ethinyl estradiol/Levonorgestrel (EE/LEVO)Acetaminophen (APAP)

Brief Summary

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

Eligibility Criteria

Inclusion 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. 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 CoC assessment. * Females of non-childbearing potential must be confirmed at the Screening Visit. * Have a Body Mass Index (BMI) between 25 and 40 kg/m2, both inclusive and weigh at least 60 kg. Exclusion Criteria: * 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 (cohort 1 and cohort 2), type I or type II diabetes mellitus,

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