A Study to Investigate Safety and How AZD4248 Works
Phase 1
124
about 11 months
18–75
5 sites in CA, IL, MI +2
What this study is about
Researchers are testing the safety, how well AZD4248 works in the body (pharmacokinetics), and how it affects the body (pharmacodynamics) when given as a pill or injection. The trial also looks at whether people with kidney disease can measure creatinine at home.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take AZD4248
- 2.Take Placebo
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: Part D: Intra- and inter-participant variability of estimated glomerular filtration rate (eGFR) derived from home self-testing device measurements, Parts A, B, and C: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary: Accumulation ratio for AUC (Rac AUC), Accumulation ratio for Cmax (Rac Cmax), Apparent total body clearance (CL/F), Dose normalized Cmax (Cmax/D), Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)], Maximum observed drug concentration (Cmax), Part D: Estimated glomerular filtration rate (eGFR), Part D: Intra- and inter-participant variability of eGFR derived from laboratory measurements
Renal