A Study to Investigate the Phototoxic Potential of Faldaprevir

Boehringer Ingelheim

Status and phase: Withdrawn; Phase 1

Conditions: Healthy

Treatments: Drug: Faldaprevir high dose; Drug: Ciprofloxacin; Drug: Placebo; Drug: Faldaprevir low dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02114671

2013-000767-88 (EudraCT Number)

1241.42

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 4 patient groups, including a placebo group

Faldaprevir QD high dose

Experimental group

Description:

capsules, oral administration with 240 ml water, fed conditions

Treatment:

Drug: Faldaprevir high dose

Faldaprevir QD low dose

Experimental group

Description:

tablets/capsules, oral administration with 240 ml water, fed conditions

Treatment:

Drug: Faldaprevir low dose

Placebo

Placebo Comparator group

Description:

capsules, oral administration with 240 ml water, fed conditions

Treatment:

Drug: Placebo

Ciprofloxacin

Active Comparator group

Description:

tablets, oral administration with 240 ml water, fed conditions

Treatment:

Drug: Ciprofloxacin