BAY 3389934
DrugSolution for intravenous infusion
NCT Number: NCT07176728
This study is designed to evaluate a new investigational drug, BAY 3389934, in healthy Japanese volunteers. The primary purpose is to see how safe the drug is and how well it is tolerated by the body when given at different doses. BAY 3389934 is being developed for the potential treatment of a serious blood clotting condition called sepsis-associated disseminated intravascular coagulation (DIC). The research will be conducted as a single-blind, placebo-controlled, dose-escalation study. This means that participants will be randomly assigned to receive either the active drug (BAY 3389934) or a placebo (an inactive substance), and they will not know which one they are receiving. The study will involve up to 16 healthy male and female Japanese participants, aged between 18 and 55. The study consists of two parts, called dose steps. In the first step, participants will receive a single 4-hour intravenous (IV) infusion of BAY 3389934 at a dose of 15 mg/h, or a placebo. Based on the safety and tolerability results from this first step, a second, higher dose will be selected for the next group of participants in the second step. Throughout the study, researchers will closely monitor participants for any side effects (adverse events). They will also collect blood and urine samples to study how the drug is absorbed, distributed, and eliminated by the body (pharmacokinetics or PK) and what effects it has on the body's clotting system (pharmacodynamics or PD). This involves measuring specific substances in the blood, such as activated partial thromboplastin time (aPTT) and prothrombin time (PT). Participants will stay at the study center for 4 days and will have a follow-up visit 3 to 5 days after they are discharged. The information gathered from this study is crucial for the future clinical development of BAY 3389934 in Japan and for designing future studies in patients with septic DIC.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
SOUSEIKAI Fukuoka Mirai Hospital, Fukuoka, Fukuoka Pref, Japan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Solution for intravenous infusion
Solution for intravenous infusion
Time frame: From start of study intervention until the follow-up visit (approximately 5 weeks)
Investigate the safety and tolerability of BAY 3389934 15 mg/h and a second, higher dose (will be determined based on the result of 15 mg/h dose step), 4-hours infusion, respectively.
Time frame: From pre-dose (0 hours) up to 48 hours after start of infusion
Maximum observed drug concentration (Cmax) within the given timeframe. PK parameters will be calculated using the non-compartmental method according to the sponsor's current guidelines using PhoenixTM (Certara, Princeton, New Jersey).
Time frame: From pre-dose (0 hours) up to 48 hours after start of infusion
Area under the concentration vs. time curve from zero to infinity (AUC) within the given timeframe. In the case of an unexpected event of e.g., an exceedingly large (>20%) extrapolated portion of AUC (AUC(tlast-∞)), the parameter AUC(0-tlast) may be evaluated as main parameter. PK parameters will be calculated using the non-compartmental method according to the sponsor's current guidelines using PhoenixTM (Certara, Princeton, New Jersey).
Time frame: From pre-dose (0 hours) up to 48 hours after start of infusion
Maximum observed drug concentration (Cmax) divided by dose (Cmax/D) within the given timeframe. PK parameters will be calculated using the non-compartmental method according to the sponsor's current guidelines using PhoenixTM (Certara, Princeton, New Jersey).
Time frame: From pre-dose (0 hours) up to 48 hours after start of infusion
Area under the concentration vs. time curve from zero to infinity (AUC) divided by dose (AUC/D) in the given timeframe. In the case of an unexpected event of e.g., an exceedingly large (>20%) extrapolated portion of AUC (AUC(tlast-∞)), the parameter AUC(0-tlast) may be evaluated as main parameter. PK parameters will be calculated using the non-compartmental method according to the sponsor's current guidelines using PhoenixTM (Certara, Princeton, New Jersey).
Time frame: From pre-dose (0 hours) up to 48 hours after start of infusion
Half-life associated with the terminal slope (t1/2) of BAY 3389934 in plasma within the given timeframe.
PK parameters will be calculated using the non-compartmental method according to the sponsor's current guidelines using PhoenixTM (Certara, Princeton, New Jersey).
Time frame: From pre-dose up to 5 hours after beginning of infusion.
Measure Activated partial thromboplastin time (aPTT). Assessed as the maximal ratio to baseline and the ratio to baseline at 4 hours and 5 hours after beginning of infusion.
Time frame: From pre-dose up to 5 hours after beginning of infusion.
Prothrombin time (PT). Assessed as the maximal ratio to baseline and the ratio to baseline at 4 hours and 5 hours after beginning of infusion.
Bayer
Industry
A Single-blind, Placebo Controlled, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BAY 3389934 Intravenous Infusions in Healthy Japanese Participants.
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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