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

Phase 1RecruitingNCT07534592

AstraZeneca40 enrolled

Overview

The study has 2 groups, one each focusing on co-administration of elecoglipron and atorvastatin or rosuvastatin to assess the pharmacokinetics (PK) of atorvastatin in healthy participants.

This is an open-label, fixed-sequence, conducted at 2 study centers with 2 groups. Group 1 is designed to assess the PK of atorvastatin in healthy participants when administered alone and in combination with multiple doses of elecoglipron. This group will consist of a screening period, 6 treatment periods, and a follow-up visit. Each participant in Group 1 will be involved in the study for approximately 15 weeks. Group 2 is designed to assess the PK of rosuvastatin in healthy participants when administered alone and in combination with multiple doses of elecoglipron. This group will consist of a screening period, 5 treatment periods, and a follow-up visit. Each participant in Group 2 will be involved in the study for approximately 16 weeks. Group 1 and Group 2 are independent and non-sequential parts in this study. All parts of this study will be performed in healthy male and female participants

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Participants

Interventions

ElecoglipronDRUG

Elecoglipron will be administered as oral tablet.

AtorvastatinDRUG

Atorvastatin will be administered as oral tablet.

RosuvastatinDRUG

Rosuvastatin will be administered as oral tablet.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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.

Locations (2)

Research Site

Glendale, California, United States

NOT_YET_RECRUITING

Research Site

Brooklyn, Maryland, United States

RECRUITING

Outcomes

Primary Outcomes

Area under concentration-time curve from time 0 to infinity (AUCinf) of atorvastatin

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

Time frame: Group 1: Day 1 to Day 71

Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of atorvastatin

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

Time frame: Group 1: Day 1 to Day 71

Maximum observed drug concentration (Cmax) of atorvastatin

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

Time frame: Group 1: Day 1 to Day 71

AUCinf of rosuvastatin

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

Time frame: Group 2: Day 1 to Day 76

AUClast of rosuvastatin

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

Time frame: Group 2: Day 1 to Day 76

Cmax of rosuvastatin

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

Time frame: Group 2: Day 1 to Day 76

Ratio of Atorvastatin (Atorvastatin + elecoglipron) to Atorvastatin (alone) based on AUCinf (R AUCinf) of atorvastatin

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

Central Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

Data from ClinicalTrials.gov

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Central Contacts

Secondary Outcomes