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

Purpose

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.

Condition

  • Healthy Participants

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group 1: Period 1 		Participants will receive a single dose of atorvastatin on Day 1.
  • Drug: Atorvastatin
    Atorvastatin will be administered as oral tablet.
Experimental
Group 1: Period 2 		Participants will receive single dose of atorvastatin on Day 5 and then receive multiple doses of elecoglipron from Day 7 to Day 40.
  • Drug: Elecoglipron
    Elecoglipron will be administered as oral tablet.
  • Drug: Atorvastatin
    Atorvastatin will be administered as oral tablet.
Experimental
Group 1: Period 3 		Participants will receive single dose of atorvastatin on Day 41 and then receive multiple doses of elecoglipron from Day 41 to Day 43.
  • Drug: Elecoglipron
    Elecoglipron will be administered as oral tablet.
  • Drug: Atorvastatin
    Atorvastatin will be administered as oral tablet.
Experimental
Group 1: Period 4 		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.
  • Drug: Elecoglipron
    Elecoglipron will be administered as oral tablet.
  • Drug: Atorvastatin
    Atorvastatin will be administered as oral tablet.
Experimental
Group 1: Period 5 		Participants will receive single dose of atorvastatin and elecoglipron on Day 59. Participants will receive elecoglipron alone on Day 60 to Day 61.
  • Drug: Elecoglipron
    Elecoglipron will be administered as oral tablet.
  • Drug: Atorvastatin
    Atorvastatin will be administered as oral tablet.
Experimental
Group 1: Period 6 		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.
  • Drug: Elecoglipron
    Elecoglipron will be administered as oral tablet.
  • Drug: Atorvastatin
    Atorvastatin will be administered as oral tablet.
Experimental
Group 2: Period 1 		Participants will receive single dose of rosuvastatin on Day 1 and then multiple doses of elecoglipron from Day 5 to Day 38.
  • Drug: Elecoglipron
    Elecoglipron will be administered as oral tablet.
  • Drug: Rosuvastatin
    Rosuvastatin will be administered as oral tablet.
Experimental
Group 2: Period 2 		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.
  • Drug: Elecoglipron
    Elecoglipron will be administered as oral tablet.
  • Drug: Rosuvastatin
    Rosuvastatin will be administered as oral tablet.
Experimental
Group 2: Period 3 		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.
  • Drug: Elecoglipron
    Elecoglipron will be administered as oral tablet.
  • Drug: Rosuvastatin
    Rosuvastatin will be administered as oral tablet.
Experimental
Group 2: Period 4 		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.
  • Drug: Elecoglipron
    Elecoglipron will be administered as oral tablet.
  • Drug: Rosuvastatin
    Rosuvastatin will be administered as oral tablet.
Experimental
Group 2: Period 5 		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.
  • Drug: Elecoglipron
    Elecoglipron will be administered as oral tablet.
  • Drug: Rosuvastatin
    Rosuvastatin will be administered as oral tablet.

Recruiting Locations

Research Site
Brooklyn, Maryland 21225

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Detailed Description

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