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

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.

Study Overview

• Status: Withdrawn
• Conditions: Healthy
• Intervention / Treatment: Drug: Faldaprevir high dose; Drug: Faldaprevir low dose; Drug: Placebo; Drug: Ciprofloxacin

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom
    • 1241.42.44001 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): October 1, 2014
• Study Completion (Anticipated): October 1, 2014

Study Registration Dates

• First Submitted: April 11, 2014
• First Submitted That Met QC Criteria: April 14, 2014
• First Posted (Estimate): April 15, 2014

Study Record Updates

• Last Update Posted (Estimate): June 25, 2014
• Last Update Submitted That Met QC Criteria: June 24, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ciprofloxacin
• Other Study ID Numbers: 1241.42; 2013-000767-88 (EudraCT Number: EudraCT)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No