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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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The purpose of this study is to determine how the experimental medication AZD0780 impacts the pharmacokinetics (PK) of metformin, a common medication used to treat type 2 diabetes mellitus, when given together in healthy participants.
This is an open-label, 2-period, fixed-sequence study in healthy participants (males and females), performed at a single Clinical Unit. The study will assess the PK of metformin when administered alone and in combination with a single dose of AZD0780.
The study will comprise:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin/Metformin + AZD0780 | Experimental | Participants will receive a single dose of metformin on Day 1 in Treatment Period 1 followed by a washout period of 7 days. In Treatment Period 2, participants will receive a single dose of AZD0780 followed by a single dose of metformin on Day 8. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD0780 | Drug | AZD0780 will be administered orally. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under concentration time curve from time 0 to infinity (AUCinf) | To assess the effect of AZD0780 on the PK of metformin. | Days 1 to 3 and Days 8 to 10 |
| Area under concentration curve from time 0 to the last quantifiable concentration (AUClast) | To assess the effect of AZD0780 on the PK of metformin. | Days 1 to 3 and Days 8 to 10 |
| Maximum observed drug concentration (Cmax) | To assess the effect of AZD0780 on the PK of metformin. | Days 1 to 3 and Days 8 to 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events (AEs) | To examine the safety and tolerability of AZD0780 in combination with metformin. | Day 1 until Follow-up visit or early discontinuation (Up to Day 18) |
| Apparent total body clearance (CL/F) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Brooklyn | Maryland | 21225 | United States |
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| Label | URL |
|---|---|
| Thank You Card | View source |
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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://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. ''Yes", indicates that AZ is accepting requests for IPD, but this does not mean all requests will be approved.
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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 refer 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. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| C566337 | Hypercholesterolemia, Autosomal Dominant, 3 |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Metformin |
| Drug |
Metformin will be administered orally. |
|
To assess the effect of AZD0780 on other PK parameters of metformin.
| Days 1 to 3 and Days 8 to 10 |
| Apparent volume of distribution based on the terminal phase (Vz/F) | To assess the effect of AZD0780 on other PK parameters of metformin. | Days 1 to 3 and Days 8 to 10 |
| Terminal elimination half life (t½λz) | To assess the effect of AZD0780 on other PK parameters of metformin. | Days 1 to 3 and Days 8 to 10 |
| Time to reach maximum observed concentration (tmax) | To assess the effect of AZD0780 on other PK parameters of metformin. | Days 1 to 3 and Days 8 to 10 |
| Renal clearance (CLR) | To assess the effect of AZD0780 on other PK parameters of metformin. | Days 1 to 3 and Days 8 to 10 |
| Amount of unchanged drug excreted into urine (Ae) | To assess the effect of AZD0780 on other PK parameters of metformin. | Days 1 to 3 and Days 8 to 10 |
| Percentage of dose excreted unchanged in urine (fe) | To assess the effect of AZD0780 on other PK parameters of metformin. | Days 1 to 3 and Days 8 to 10 |