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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Period 1 | Experimental | Participants will receive a single dose of atorvastatin on Day 1. |
|
| Group 1: Period 2 | Experimental | Participants will receive single dose of atorvastatin on Day 5 and then receive multiple doses of elecoglipron from Day 7 to Day 40. |
|
| Group 1: Period 3 | Experimental | Participants will receive single dose of atorvastatin on Day 41 and then receive multiple doses of elecoglipron from Day 41 to Day 43. |
|
| Group 1: Period 4 | Experimental | 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 1: Period 5 | Experimental | Participants will receive single dose of atorvastatin and elecoglipron on Day 59. Participants will receive elecoglipron alone on Day 60 to Day 61. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elecoglipron | Drug | Elecoglipron will be administered as oral tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. | Group 2: Day 1 to Day 76 |
| Ratio of Atorvastatin (Atorvastatin + elecoglipron) to Atorvastatin (alone) based on AUCinf (R AUCinf) of atorvastatin |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) and adverse event of special interest (AESI) | To examine the safety and tolerability of elecoglipron alone and in combination with atorvastatin (Group 1) or rosuvastatin (Group 2) in healthy participants. | Group 1: Day -28 to Day 74; Group 2: Day -28 to Day 79 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Glendale | California | 91206 | United States | ||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptriaIs.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/ Disclosure
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Group 1: Period 6 | Experimental | 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 2: Period 1 | Experimental | Participants will receive single dose of rosuvastatin on Day 1 and then multiple doses of elecoglipron from Day 5 to Day 38. |
|
| Group 2: Period 2 | Experimental | 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 2: Period 3 | Experimental | 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 2: Period 4 | Experimental | 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 2: Period 5 | Experimental | 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. |
|
| Atorvastatin | Drug | Atorvastatin will be administered as oral tablet. |
|
| Rosuvastatin | Drug | Rosuvastatin will be administered as oral tablet. |
|
To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants. |
| Group 1: Day 1 to Day 71 |
| Ratio of Atorvastatin (Atorvastatin + elecoglipron) to Atorvastatin (alone) based on AUClast (R AUClast) of atorvastatin | To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants. | Group 1: Day 1 to Day 71 |
| Ratio of Atorvastatin (Atorvastatin + elecoglipron) to Atorvastatin (alone) based on Cmax (R Cmax) of atorvastatin | To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants. | Group 1: Day 1 to Day 71 |
| Terminal elimination half-life (t1/2λz) of atorvastatin | To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants. | Group 1: Day 1 to Day 71 |
| Terminal rate constant (λz) of atorvastatin | To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants. | Group 1: Day 1 to Day 71 |
| Time to reach maximum observed concentration (tmax) of atorvastatin | To assess the effect of multiple doses of elecoglipron on the PK of a single dose of atorvastatin in healthy participants. | Group 1: Day 1 to Day 71 |
| Ratio of Rosuvastatin (Rosuvastatin + elecoglipron) to Rosuvastatin (alone) based on AUCinf (R AUCinf) of rosuvastatin | To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants. | Group 2: Day 1 to Day 76 |
| Ratio of Rosuvastatin (Rosuvastatin + elecoglipron) to Rosuvastatin (alone) based on AUClast (R AUClast) of rosuvastatin | To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants. | Group 2: Day 1 to Day 76 |
| Ratio of Rosuvastatin (Rosuvastatin + elecoglipron) to Rosuvastatin (alone) based on Cmax (R Cmax) of rosuvastatin | To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants. | Group 2: Day 1 to Day 76 |
| t1/2λz of rosuvastatin | To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants. | Group 2: Day 1 to Day 76 |
| λz of rosuvastatin | To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants. | Group 2: Day 1 to Day 76 |
| tmax of rosuvastatin | To assess the effect of multiple doses of elecoglipron on the PK of a single dose of rosuvastatin in healthy participants. | Group 2: Day 1 to Day 76 |
| Brooklyn |
| Maryland |
| 21225 |
| United States |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |