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
2 other identifiers
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2014
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 11, 2014
CompletedFirst Posted
Study publicly available on registry
April 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedJune 25, 2014
June 1, 2014
6 months
April 11, 2014
June 24, 2014
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Degree of phototoxic effects by phototoxic index
7 days
Study Arms (4)
Faldaprevir QD high dose
EXPERIMENTALcapsules, oral administration with 240 ml water, fed conditions
Faldaprevir QD low dose
EXPERIMENTALtablets/capsules, oral administration with 240 ml water, fed conditions
Placebo
PLACEBO COMPARATORcapsules, oral administration with 240 ml water, fed conditions
Ciprofloxacin
ACTIVE COMPARATORtablets, oral administration with 240 ml water, fed conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- Any relevant deviation from healthy conditions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
1241.42.44001 Boehringer Ingelheim Investigational Site
Edinburgh, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2014
First Posted
April 15, 2014
Study Start
April 1, 2014
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
June 25, 2014
Record last verified: 2014-06