Healthy Participants
Conditions
Keywords
Pharmacokinetics, Statin exposure, Fixed sequence, Type 2 diabetes, Obesity
Brief summary
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.
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, 7 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
Interventions
DRUGElecoglipron
Elecoglipron will be administered as oral tablet.
DRUGAtorvastatin
Atorvastatin will be administered as oral tablet.
DRUGRosuvastatin
Rosuvastatin will be administered as oral tablet.
Sponsors
AstraZeneca
Parexel
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under concentration-time curve from time 0 to infinity (AUCinf) of atorvastatin | Group 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 atorvastatin | Group 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 atorvastatin | Group 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 rosuvastatin | Group 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 rosuvastatin | Group 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 rosuvastatin | Group 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 atorvastatin | Group 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 atorvastatin | Group 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 atorvastatin | Group 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 atorvastatin | Group 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 atorvastatin | Group 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 atorvastatin | Group 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 rosuvastatin | Group 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 rosuvastatin | Group 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 rosuvastatin | Group 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 rosuvastatin | Group 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 rosuvastatin | Group 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 rosuvastatin | Group 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (AEs) and adverse event of special interest (AESI) | Group 1: Day -28 to Day 74; Group 2: Day -28 to Day 79 | To examine the safety and tolerability of elecoglipron alone and in combination with atorvastatin (Group 1) or rosuvastatin (Group 2) in healthy participants. |
Countries
United States
Outcome results
None listed