drugset / Trial / NCT01505907

Pharmacokinetic Study of CXB909 in Healthy Male Subjects

NCT01505907 ↗

Phase 1/2 Unknown 40 enrolled CeNeRx BioPharma Inc.
RandomizedSingle-groupTriple-blind

Summary

The primary objective of this dose escalation study is to examine the safety, tolerability, and pharmacokinetic properties of single-doses of CXB909, compared to placebo, in healthy male volunteers. This study may evaluate five (5) dose levels of CXB909; however, the number of dose levels, as well as the dosages, may be adjusted after evaluation of in-study analysis of the safety, tolerability, and pharmacokinetic data. This study will attempt to identify the maximum tolerated single dose of CXB909.

Timeline

Start
2012-12
Primary completion
2013-12
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Subject CXB909 Unknown 15 mg —
Subject CXB909 Unknown 30 mg —
Subject CXB909 Unknown 60 mg —
Subject CXB909 Unknown 120 mg —
Subject CXB909 Unknown 250 mg —

Indications

No indication recorded.