drugset / Trial / NCT02860806

Safety, Tolerability, Pharmacokinetic and Absolute Bioavailability Study of JNJ-63623872 Administered as an Intravenous Infusion and a 600-Milligram (mg) Oral Dose in Healthy Adults

NCT02860806

Phase 1 Completed 66 enrolled Janssen-Cilag International NV
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to characterize the single-dose pharmacokinetic (PK) of single escalating intravenous (IV) doses of JNJ-63623872 administered as a continuous infusion; to evaluate the safety and tolerability of single escalating IV doses of JNJ-63623872 administered as a continuous infusion; to characterize the single-dose PK of JNJ-63623872 of one selected dose administered as a continuous IV infusion at various durations and to characterize the single- and repeat-dose PK of JNJ-63623872 administered as a continuous infusion.

Timeline

Start
2016-08-08
Primary completion
2017-06-06
Completion
2017-06-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Pimodivir Small molecule 100 mg Intravenous
Subject Pimodivir Small molecule 200 mg Intravenous
Subject Pimodivir Small molecule 300 mg Intravenous
Subject Pimodivir Small molecule 600 mg Intravenous

Indications

No indication recorded.