drugset / Trial / NCT02114671
A Study to Investigate the Phototoxic Potential of Faldaprevir
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ciprofloxacin | Small molecule | — | Oral |
| Subject | Faldaprevir | Small molecule | — | Oral |
Indications
No indication recorded.