A Study to Investigate the Phototoxic Potential of Faldaprevir

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Faldaprevir high dose
* Drug: Placebo
* Drug: Ciprofloxacin
* Drug: Faldaprevir low dose


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Faldaprevir QD high dose<br>capsules, oral administration with 240 ml water, fed conditions | Drug: Faldaprevir high dose<br>* capsules, oral<br>|
| Experimental: Faldaprevir QD low dose<br>tablets/capsules, oral administration with 240 ml water, fed conditions | Drug: Faldaprevir low dose<br>* capsules, oral<br>|
| Placebo Comparator: Placebo<br>capsules, oral administration with 240 ml water, fed conditions | Drug: Placebo<br>* capsule, oral<br>|
| Active Comparator: Ciprofloxacin<br>tablets, oral administration with 240 ml water, fed conditions | Drug: Ciprofloxacin<br>* tablets, oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of phototoxic effects by phototoxic index |  | 7 days |