What question did this study set out to answer?

To assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of escalating single doses of the direct factor Xa inhibitor BAY 59-7939 in healthy subjects.

September 30, 2005Clinical Pharmacology & Therapeutics

Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939, an oral, direct factor Xa inhibitor

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Why the study?

What are the safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939 in healthy male subjects?

Population

healthy male subjects

Design

Other

Authors

DKDagmar KubitzaBayer (United States)MBMichael BeckaBayer (Germany)BVBarbara VoithBayer (Germany)

Discussion

Member takes

Implication

Supports further development in patients; leaves open efficacy and safety in target populations.

Key Points

To assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of escalating single doses of the direct factor Xa inhibitor BAY 59-7939 in healthy subjects.
Administered single oral doses across a wide dose range to healthy male subjects to profile pharmacokinetics and tolerability.
BAY 59-7939 demonstrated favorable tolerability across all evaluated single-dose ranges in healthy male subjects.
The agent exhibited predictable pharmacokinetic and pharmacodynamic profiles alongside effective, specific direct factor Xa inhibition.

Structured PICO

What are the safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939 in healthy male subjects?

Population

healthy male subjects

Intervention

single doses of BAY 59-7939 (oral, direct factor Xa inhibitor)

Outcome

Safety, pharmacodynamics, and pharmacokineticssafety

Single doses of the oral direct factor Xa inhibitor BAY 59-7939 are well tolerated with predictable pharmacokinetics and pharmacodynamics in healthy males.

Cite This Study

Kubitza et al. (2005) studied this question.

synapsesocial.com/papers/69dd1cd60219ae88a9e52fa3 https://doi.org/10.1016/j.clpt.2005.06.011

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Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939, an oral, direct factor Xa inhibitor

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939, an oral, direct factor Xa inhibitor

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Also Consider

Also Consider