A Study to Investigate the Effect of AZD0780 on Metformin Pharmacokinetics in Healthy Adult Volunteers Aged 18 to 55 Years
- Conditions
- Healthy Participants
- Interventions
- Registration Number
- NCT07216131
- Lead Sponsor
- AstraZeneca
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 14
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Metformin/Metformin + AZD0780 AZD0780 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. Metformin/Metformin + AZD0780 Metformin 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
Renal clearance (CLR) Days 1 to 3 and Days 8 to 10 To assess the effect of AZD0780 on other PK parameters of 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.