A Study to Investigate the Phototoxic Potential of Faldaprevir

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02114671
• Other study ID #: 1241.42
• Secondary ID: 2013-000767-88
• Status: Withdrawn
• Phase: Phase 1
• First received: April 11, 2014
• Last updated: June 24, 2014
• Start date: April 2014
• Est. completion date: October 2014

Study information

• Verified date: June 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Faldaprevir high dose
capsules, oral
• Placebo
capsule, oral
• Ciprofloxacin
tablets, oral
• Faldaprevir low dose
capsules, oral

Locations

Country	Name	City	State
United Kingdom	1241.42.44001 Boehringer Ingelheim Investigational Site	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with drug related adverse events		17 days	No
Primary	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	Yes
Primary	Percentage of subjects with drug related adverse events		17 days	No
Secondary	Degree of phototoxic effects by phototoxic index		7 days	Yes