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Ethinyl estradiol/Levonorgestrel (EE/LEVO) / AZD9550 / Healthy Participants · Phase 1 Trial
ClinicalTrials.gov · August 18, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 drug–drug interaction pharmacokinetic study examining how AZD6234, AZD9550, and their combination affect oral contraceptive exposure in healthy women with overweight or obesity. No results are yet available in this registry record; the study is still recruiting and designed to measure plasma concentrations and derived PK parameters across multiple sampling intervals.
Phase 1, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Healthy Participants; Female; age from 35 Years; to 75 Years; accepts healthy volunteers. Intervention: Cohort-1: AZD6234 + EE/LEVO + Acetaminophen (APAP); Cohort-2: AZD6234+AZD9550+EE/LEVO+APAP; Cohort-3: AZD9550 + EE/LEVO + APAP; Cohort-4: AZD6234+AZD9550+EE/LEVO+APAP. Compared with: Combined oral contraceptive ethinyl estradiol/levonorgestrel alone (baseline/predose). n = 50. 2 sites: United States.
This is a Phase 1 drug–drug interaction pharmacokinetic study examining how AZD6234, AZD9550, and their combination affect oral contraceptive exposure in healthy women with overweight or obesity. No results are yet available in this registry record; the study is still recruiting and designed to measure plasma concentrations and derived PK parameters across multiple sampling intervals.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This study will provide pharmacokinetic data on potential drug–drug interactions between novel AstraZeneca compounds and oral contraceptives, but results are needed before any clinical implications can be assessed. The use of healthy volunteers and surrogate endpoints limits direct generalizability to therapeutic populations.
This is a Phase 1 drug–drug interaction study still recruiting, with no results posted; it measures pharmacokinetic surrogates in a small healthy population and cannot yet inform clinical practice.
As stated by the source record.
Quoted from the source exactly as published.
This study will provide pharmacokinetic data on potential drug–drug interactions between novel AstraZeneca compounds and oral contraceptives, but results are needed before any clinical implications can be assessed. The use of healthy volunteers and surrogate endpoints limits direct generalizability to therapeutic populations.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07013643). This is a study registration, not published results. Lead sponsor: AstraZeneca. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 50 participants (ESTIMATED). Conditions: Healthy Participants. Interventions: DRUG: AZD6234; DRUG: Ethinyl estradiol/Levonorgestrel (EE/LEVO); DRUG: Acetaminophen (APAP); DRUG: AZD9550. Primary outcome measures: Area under the concentration-time curve from time 0 to infinity (AUCinf) of EE and LEVO , Cohort 1: At predefined intervals from Day -5 up to Day 99; Cohort 2 : At pre-defined interval from Day -5 up to Day 169; Cohort 3: At predefined intervals from Day -5 up to Day 225; Cohort 4: At predefined intervals from Day -5 up to Day 253; Area under the concentration-time curve from time of dosing to the last measurable concentration (AUClast) of EE and LEVO , Cohort 1: At predefined intervals from Day -5 up to Day 99; Cohort 2 : At pre-defined interval from Day -5 up to Day 169; Cohort 3: At predefined intervals from Day -5 up to Day 225; Cohort 4: At predefined intervals from Day -5 up to Day 253; Maximum plasma concentration (Cmax) of EE and LEVO , Cohort 1: At predefined intervals from Day -5 up to Day 99; Cohort 2 : At pre-defined interval from Day -5 up to Day 169; Cohort 3: At predefined intervals from Day -5 up to Day 225; Cohort 4: At predefined intervals from Day -5 up to Day 253; Time to reach maximum drug concentration in plasma (tmax) of EE and LEVO , Cohort 1: At predefined intervals from Day -5 up to Day 99; Cohort 2 : At pre-defined interval from Day -5 up to Day 169; Cohort 3: At predefined intervals from Day -5 up to Day 225; Cohort 4: At predefined intervals from Day -5 up to Day 253; Elimination half-life (t1/2λz) of EE and LEVO , Cohort 1: At predefined intervals from Day -5 up to Day 99; Cohort 2 : At pre-defined interval from Day -5 up to Day 169; Cohort 3: At predefined intervals from Day -5 up to Day 225; Cohort 4: At predefined intervals from Day -5 up to Day 253. 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.
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