A Study to Investigate the Phototoxic Potential of Faldaprevir

Phase 1

Withdrawn

• Conditions: Healthy
• Interventions: Drug: Faldaprevir high dose; Drug: Faldaprevir low dose; Drug: Placebo; Drug: Ciprofloxacin

• Registration Number: NCT02114671
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-11
• Study First Submitted QC: 2014-04-14
• Study First Posted: 2014-04-15
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-24
• Last Update Posted: 2014-06-25
• Primary Completion: 2014-10
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Faldaprevir QD high dose	Faldaprevir high dose	capsules, oral administration with 240 ml water, fed conditions
Faldaprevir QD low dose	Faldaprevir low dose	tablets/capsules, oral administration with 240 ml water, fed conditions
Placebo	Placebo	capsules, oral administration with 240 ml water, fed conditions
Ciprofloxacin	Ciprofloxacin	tablets, oral administration with 240 ml water, fed conditions

Primary Outcome Measures

Name	Time	Method
Number of subjects with drug related adverse events	17 days
Percentage 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

Secondary Outcome Measures

Name	Time	Method
Degree of phototoxic effects by phototoxic index	7 days

Trial Locations

Locations (1)

1241.42.44001 Boehringer Ingelheim Investigational Site; 🇬🇧 Edinburgh, United Kingdom