drugset / Trial / NCT02114671

A Study to Investigate the Phototoxic Potential of Faldaprevir

NCT02114671

Phase 1 Withdrawn Boehringer Ingelheim
RandomizedParallel-groupOpen-labelTreatment

Summary

To investigate the potential of Faldaprevir to induce skin phototoxicity, immediate or delayed type, to UV light and visible light in healthy male and female subjects. To investigate the degree, wavelength dependency, severity, pigmentation and morphology of the phototoxic effects. The persistence of the phototoxic susceptibility will be explored following cessation of study medication. Within a sunscreen sub-study, the efficacy of commercially available high factor sunscreen will also be assessed in terms of its potential to prevent any phototoxic skin responses seen. The safety and tolerability of Faldaprevir will also be assessed.

Timeline

Start
2014-04
Primary completion
2014-10
Completion
2014-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ciprofloxacin Small molecule Oral
Subject Faldaprevir Small molecule Oral

Indications

No indication recorded.