Healthy Participants
Conditions
Keywords
Renal Transporter, Multidrug and Toxic Compound Extrusion 1, Dyslipidemia, Proprotein Convertase Subtilisin/Kexin Type 9
Brief summary
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.
Detailed description
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: * A Screening Period of maximum 28 days. * Two Treatment Periods (Day -1 to Day 7 and Day 8 to Day 10) during which participants will be resident at the Clinical Unit and will receive the study intervention. * A final Follow-up Visit.
Interventions
DRUGAZD0780
AZD0780 will be administered orally.
DRUGMetformin
Metformin will be administered orally.
Sponsors
Parexel
AstraZeneca
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
* Have a body mass index (BMI) between 18 and 35 kilograms per meter squared (kg/m2) inclusive and weigh at least 50 kilograms (kg) at the Screening Visit. * Participants agree to follow study specific contraceptive requirements. * Have suitable veins for cannulation or repeated venipuncture.
Exclusion criteria
* History of any clinically important disease or disorder which may put the participant at risk because of participation in the study or influence the results. * Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV). * Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention. * History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to metformin or AZD0780. * Treatment with any lipid lowering therapy or AZD0780 within the 3 months prior to the Screening Visit. * Treatment with drugs for reduction or inhibition of proprotein convertase subtilisin/kexin type 9 (PCSK9) within the last 12 months prior to the Screening Visit (approved or investigational and apart from AZD0780). * Current or previous administration of inclisiran.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under concentration time curve from time 0 to infinity (AUCinf) | Days 1 to 3 and Days 8 to 10 | To assess the effect of AZD0780 on the PK of metformin. |
| Area under concentration curve from time 0 to the last quantifiable concentration (AUClast) | Days 1 to 3 and Days 8 to 10 | To assess the effect of AZD0780 on the PK of metformin. |
| Maximum observed drug concentration (Cmax) | Days 1 to 3 and Days 8 to 10 | To assess the effect of AZD0780 on the PK of metformin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Terminal elimination half life (t½λz) | Days 1 to 3 and Days 8 to 10 | To assess the effect of AZD0780 on other PK parameters of metformin. |
| Time to reach maximum observed concentration (tmax) | Days 1 to 3 and Days 8 to 10 | To assess the effect of AZD0780 on other PK parameters of metformin. |
| Number of participants with Adverse Events (AEs) | Day 1 until Follow-up visit or early discontinuation (Up to Day 18) | To examine the safety and tolerability of AZD0780 in combination with metformin. |
| Amount of unchanged drug excreted into urine (Ae) | Days 1 to 3 and Days 8 to 10 | To assess the effect of AZD0780 on other PK parameters of metformin. |
| Percentage of dose excreted unchanged in urine (fe) | Days 1 to 3 and Days 8 to 10 | To assess the effect of AZD0780 on other PK parameters of metformin. |
| Renal clearance (CLR) | Days 1 to 3 and Days 8 to 10 | To assess the effect of AZD0780 on other PK parameters of metformin. |
| Apparent total body clearance (CL/F) | Days 1 to 3 and Days 8 to 10 | To assess the effect of AZD0780 on other PK parameters of metformin. |
| Apparent volume of distribution based on the terminal phase (Vz/F) | Days 1 to 3 and Days 8 to 10 | To assess the effect of AZD0780 on other PK parameters of metformin. |
Countries
United States
Outcome results
None listed