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Study of Elecoglipron with Rosuvastatin and Atorvastatin in Healthy Participants

This study is looking at how a drug called elecoglipron affects the way your body handles two common cholesterol-lowering medications, atorvastatin and rosuvastatin. We want to understand if taking elecoglipron changes how much of these medications stay in your system and for how long. This is important to make sure medications work as intended when taken together. You can join if you are a healthy adult between 18 and 55 years old. The study will measure the levels of atorvastatin and rosuvastatin in your blood over time. The study aims to enroll 48 healthy participants.

Study design
This is an open-label study, meaning you and the study team will know which medications you are receiving. It involves 48 healthy participants and has two independent groups.
What's involved
If you join, you will participate for approximately 15 to 16 weeks, including a screening visit, several treatment periods where you will take the study medications, and a follow-up visit.
Compensation
Not stated in the trial record.
Follow-up
Participants in Group 1 will have their atorvastatin levels measured for up to 71 days after starting treatment. Participants in Group 2 will have a follow-up visit after their treatment periods.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07534592

A Study to Investigate the Effect of Elecoglipron on Rosuvastatin and Atorvastatin in Healthy Participants

Active, Not Recruiting
PHASE1Ages 18–55InterventionalTreatment
AstraZeneca
~48 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:ElecoglipronAtorvastatinRosuvastatin

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Area under concentration-time curve from time 0 to infinity (AUCinf) of atorvastatin
Measured over Group 1: Day 1 to Day 71
+17 more outcomes measured

Conditions

Healthy Participants

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Healthy Participants

Where it's being run

2 sites across 2 states
California1
Maryland1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

All females 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 throughout the study.
Females of non-childbearing potential must be confirmed as postmenopausal or have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion at screening visit.
Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.

Exclusion

History of any clinically important disease or disorder.
Participants with cardiovascular diseases, neuromuscular or neurogenic disease, type 1 or type 2 diabetes mellitus, or positive for human immunodeficiency virus (HIV), or uncontrolled thyroid disease.
History of acute pancreatitis, history or presence of gastrointestinal (GI) or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract.
Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
Any clinically important abnormalities in laboratory values, clinical chemistry, hematology, urinalysis results, or vital signs.
Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram at screening.
History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs with a similar chemical structure or class to elecoglipron or paracetamol.
Participants who have previously received elecoglipron within the last 6 months or was on statin treatment for ≤ 4 weeks prior to the study treatment.

What this trial measures

  • Area under concentration-time curve from time 0 to infinity (AUCinf) of atorvastatinGroup 1: Day 1 to Day 71

    To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.

  • Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of atorvastatinGroup 1: Day 1 to Day 71

    To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.

  • Maximum observed drug concentration (Cmax) of atorvastatinGroup 1: Day 1 to Day 71

    To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.

  • AUCinf of rosuvastatinGroup 2: Day 1 to Day 76

    To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.

  • AUClast of rosuvastatinGroup 2: Day 1 to Day 76

    To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.

  • Cmax of rosuvastatinGroup 2: Day 1 to Day 76

    To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.

  • Ratio of Atorvastatin (Atorvastatin + elecoglipron) to Atorvastatin (alone) based on AUCinf (R AUCinf) of atorvastatinGroup 1: Day 1 to Day 71

    To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.

  • Ratio of Atorvastatin (Atorvastatin + elecoglipron) to Atorvastatin (alone) based on AUClast (R AUClast) of atorvastatinGroup 1: Day 1 to Day 71

    To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.

  • Ratio of Atorvastatin (Atorvastatin + elecoglipron) to Atorvastatin (alone) based on Cmax (R Cmax) of atorvastatinGroup 1: Day 1 to Day 71

    To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.

  • Terminal elimination half-life (t1/2λz) of atorvastatinGroup 1: Day 1 to Day 71

    To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.

  • Terminal rate constant (λz) of atorvastatinGroup 1: Day 1 to Day 71

    To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.

  • Time to reach maximum observed concentration (tmax) of atorvastatinGroup 1: Day 1 to Day 71

    To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants.

  • Ratio of Rosuvastatin (Rosuvastatin + elecoglipron) to Rosuvastatin (alone) based on AUCinf (R AUCinf) of rosuvastatinGroup 2: Day 1 to Day 76

    To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.

  • Ratio of Rosuvastatin (Rosuvastatin + elecoglipron) to Rosuvastatin (alone) based on AUClast (R AUClast) of rosuvastatinGroup 2: Day 1 to Day 76

    To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.

  • Ratio of Rosuvastatin (Rosuvastatin + elecoglipron) to Rosuvastatin (alone) based on Cmax (R Cmax) of rosuvastatinGroup 2: Day 1 to Day 76

    To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.

  • t1/2λz of rosuvastatinGroup 2: Day 1 to Day 76

    To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.

  • λz of rosuvastatinGroup 2: Day 1 to Day 76

    To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.

  • tmax of rosuvastatinGroup 2: Day 1 to Day 76

    To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants.