Elecoglipron with Statins for Healthy Subjects

Not yet recruiting at 1 trial location

Overseen By AstraZeneca Clinical Study Information Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I use birth control if I am a sexually active man with a partner who can get pregnant.

I am postmenopausal or have had surgery that permanently prevents pregnancy.

I am not breastfeeding and will use effective birth control during the study.

Exclusion Criteria

I have had pancreatitis or digestive issues that affect how my body handles medicine.

I have had a serious disease or medical condition in the past.

Any clinically important abnormalities in laboratory values, clinical chemistry, hematology, urinalysis results, or vital signs

What Are the Treatments Tested in This Trial?

Interventions

• Elecoglipron

How Is the Trial Designed?

Group I: Group 2: Period 5 Experimental Treatment 2 Interventions

Participants will receive elecoglipron in the morning and a single dose of rosuvastatin in the evening on Day 66. Participant will continue on elecoglipron alone from Day 67 to Day 69.

Group II: Group 2: Period 4 Experimental Treatment 2 Interventions

Participants will receive elecoglipron in the morning along with a single dose of rosuvastatin on Day 60. Participant will continue elecoglipron alone from Day 61 to Day 65.

Group III: Group 2: Period 3 Experimental Treatment 2 Interventions

Participants will receive elecoglipron in the morning and a single dose of rosuvastatin in the evening on Day 45. Participant will continue on different doses of elecoglipron alone from Day 46 to Day 59.

Group IV: Group 2: Period 2 Experimental Treatment 2 Interventions

Participants will receive elecoglipron in the morning along with a single dose of rosuvastatin on Day 39. Participant will continue elecoglipron alone from Day 40 to Day 44.

Group V: Group 2: Period 1 Experimental Treatment 2 Interventions

Participants will receive single dose of rosuvastatin on Day 1 and then multiple doses of elecoglipron from Day 5 to Day 38.

Group VI: Group 1: Period 6 Experimental Treatment 2 Interventions

Participants will receive elecoglipron in the morning and a single dose of atorvastatin in the evening on Day 62. Participant will continue elecoglipron alone from Day 63 to Day 64.

Group VII: Group 1: Period 5 Experimental Treatment 2 Interventions

Participants will receive single dose of atorvastatin and elecoglipron on Day 59. Participants will receive elecoglipron alone on Day 60 to Day 61.

Group VIII: Group 1: Period 4 Experimental Treatment 2 Interventions

Participants will receive elecoglipron in the morning and a single dose of atorvastatin in the evening on Day 44. Participant will continue elecoglipron on Day 45. Participants will receive daily administration of different doses of elecoglipron alone from Day 46 to Day 58.

Group IX: Group 1: Period 3 Experimental Treatment 2 Interventions

Participants will receive single dose of atorvastatin on Day 41 and then receive multiple doses of elecoglipron from Day 41 to Day 43.

Group X: Group 1: Period 2 Experimental Treatment 2 Interventions

Participants will receive single dose of atorvastatin on Day 5 and then receive multiple doses of elecoglipron from Day 7 to Day 40.

Group XI: Group 1: Period 1 Experimental Treatment 1 Intervention

Participants will receive a single dose of atorvastatin on Day 1.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland