A Study to Investigate the Phototoxic Potential of Faldaprevir

• Status: Withdrawn
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Ciprofloxacin

Criteria

Inclusion criteria:

• Health male and female subjects with no clinically significant abnormality (according to the Investigator's assessment) identified from a complete medical history, physical examination, whole body skin assessment, 12-lead ECG, vital signs and clinical laboratory tests. In particular, there should be no evidence of abnormal photosensitivity

• Sun-reactive skin phototype I, II, or III

Exclusion criteria:

• Any relevant deviation from healthy conditions.