BAY2327949
DrugA single oral dose of 30 mg BAY2327949 given as one 30 mg IR tablet (dose might be reduced to 15 mg for group 4 according to safety assessment team decision)
NCT Number: NCT04004195
BAY2327949 is currently under clinical development for chronic kidney disease. The goal of this study is to learn more about how the body absorbs, distributes and excretes the study drug when taken once per mouth as 30mg tablet. An additional important goal of this study is to gain more information on how well the study drug is tolerated and its effect on the human body functions. The study will enroll healthy participants or patients with mild, moderate or severe reduced kidney functions matched for age, weight and gender. The results of this study will help researchers to select the best dosing of the study drug for future studies in patients.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
APEX GmbH, München, Bavaria, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Stable renal function, e.g. a serum creatinine value determined at least 3 months before the pre-study visit should not vary by more than 25% from the serum creatinine value determined at the pre-study visit confirmed by nephrologist or general practitioner the patient is under care.
Exclusion criteria
A single oral dose of 30 mg BAY2327949 given as one 30 mg IR tablet (dose might be reduced to 15 mg for group 4 according to safety assessment team decision)
Time frame: From pre-dose until follow-up (10-12 days after dosing).
Cmax: Maximum observed drug concentration in measured matrix after single dose administration
Time frame: From pre-dose until follow-up (10-12 days after dosing).
AUC:Area under the concentration vs. time curve from zero to infinity after single (first) dose.
AUC(0-tlast) will be used as primary variables if mean AUC(tlast-∞) >20% of AUC
Time frame: From pre-dose until follow-up (10-12 days after dosing).
Cmax,u: Cmax based on the unbound plasma concentrations of the study drug
Time frame: From pre-dose until follow-up (10-12 days after dosing).
AUC(0-tlast)u will be used as primary variables if mean AUC(tlast-∞) >20% of AUC
Time frame: Approximate 14 days (from starting treatment to end of follow-up)
Time frame: From Day -1 until Day 4 (72h after dosing)
Time frame: From Day -1 until Day 4 (72h after dosing)
Bayer
Industry
Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Single Oral Dose of BAY2327949 Given as Immediate Release Tablet in Male and Female Participants in a Multi-center, Non-randomized, Non-controlled, Non-blinded Study With Group Stratification in Participants With Renal Impairment and Healthy Participants Matched for Age, Gender, and Weight
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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