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Trial record 37 of 50 for:    BI 201335 OR faldaprevir

A Study to Investigate the Phototoxic Potential of Faldaprevir

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ClinicalTrials.gov Identifier: NCT02114671
Recruitment Status : Withdrawn
First Posted : April 15, 2014
Last Update Posted : June 25, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Faldaprevir high dose Drug: Placebo Drug: Ciprofloxacin Drug: Faldaprevir low dose Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2014
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2014

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




Primary Outcome Measures :
  1. Number of subjects with drug related adverse events [ Time Frame: 17 days ]
  2. 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 [ Time Frame: 7 days ]
  3. Percentage of subjects with drug related adverse events [ Time Frame: 17 days ]

Secondary Outcome Measures :
  1. Degree of phototoxic effects by phototoxic index [ Time Frame: 7 days ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114671


Locations
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United Kingdom
1241.42.44001 Boehringer Ingelheim Investigational Site
Edinburgh, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02114671     History of Changes
Other Study ID Numbers: 1241.42
2013-000767-88 ( EudraCT Number: EudraCT )
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: June 25, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
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Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors