drugset / Trial / NCT02114203

Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Study Of PF-04447943, Co-Administered With And Without Hydroxyurea, In Subjects With Stable Sickle Cell Disease

NCT02114203

Phase 1 Completed 30 enrolled Pfizer
RandomizedTriple-blindBasic science

Summary

This study is being conducted to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of an investigational drug, PF-04447943, in subjects with stable sickle cell disease with and without co-administration with hydroxyurea. This study will also aid in selecting the doses for future studies and evaluation of substances in the blood which may help access the effectiveness of the drug.

Timeline

Start
2014-12
Primary completion
2016-09
Completion
2016-09

Drugs

EvaluationDrugModalityDoseRoute
Subject EDELINONTRINE Small molecule 5 mg Oral
Subject EDELINONTRINE Small molecule 25 mg Oral

Indications