A Study to Investigate the Phototoxic Potential of Faldaprevir

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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02114671

Enrollment

Registered

2014-04-15

Start date

2014-04-30

Completion date

2014-10-31

Last updated

2014-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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.

Interventions

DRUGFaldaprevir high dose

capsules, oral

DRUGPlacebo

capsule, oral

DRUGCiprofloxacin

tablets, oral

DRUGFaldaprevir low dose

capsules, oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Number of subjects with drug related adverse events	17 days
Change in minimum erythema dose (MED) at each wavelength tested, before and during treatment. The change will be quantified by the phototoxic index at 24 hrs (delayed erythema) derived by dividing the baseline MED by that during treatment	7 days
Percentage of subjects with drug related adverse events	17 days

Secondary

Measure	Time frame
Degree of phototoxic effects by phototoxic index	7 days

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026