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A Study to Investigate the Phototoxic Potential of Faldaprevir

Healthy Clinical Trial

Official title:
A Randomised, Assessor-blind, Placebo and Active Controlled, Parallel Group Study to Assess the Phototoxic Potential of Faldaprevir (Administered Orally, Once Daily) for 6 Days in Healthy Male and Female Subjects

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02114671
Study type Interventional
Source Boehringer Ingelheim
Contact
Status Withdrawn
Phase Phase 1
Start date April 2014
Completion date October 2014
View Details
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