TMC435-TiDP16-C125 - Study in Healthy Volunteers to Evaluate the Potential of TMC435 to Increase the Sensitivity of the Skin Towards Exposure to Sun Light
Primary Purpose
Hepatitis C Virus
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
TMC435
Placebo
Ciprofloxacin
Sponsored by

About this trial
This is an interventional treatment trial for Hepatitis C Virus focused on measuring Hepatitis C virus, TMC435-TiDP16-C125, TMC435-C125, TMC435, TMC435350, protease inhibitor, HCV, Hepatitis C, photosensitivity, phototoxicity
Eligibility Criteria
Inclusion Criteria:
- Skin type I to III
- No ultraviolet exposure on the back for 4 weeks prior to baseline phototesting
- Normal skin response during baseline phototesting
- Body Mass Index of 18.0 to 30.0 kg/m2
- Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram.
Exclusion Criteria:
- History of hypersensitivity to sunlight or artificial source of intense light, especially UV light
- history or currently active porphyria or lupus erythematosus
- Positive plasma porphyrin scan and lupus erythematosus antibodies
- Active skin disorders on the back where phototesting will be performed
- Infection with Hepatitis A, B or C virus
- Infection with the human immunodeficiency virus (HIV)
- Women who are pregnant or breastfeeding
- History of or any current medical condition which could impact the safety of the participant in the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
001
002
003
Arm Description
TMC435 one morning TMC435 dose between 75 and 150 mg and a placebo dose at noon and in the evening for 9 days
Placebo placebo dose in the morning at noon and in the evening for 9 days
Ciprofloxacin one morning placebo dose and a noon and evening dose of ciprofloxacin 500 mg for 9 days
Outcomes
Primary Outcome Measures
The effect of TMC435 versus placebo on the sensitivity of the skin towards sun light
Secondary Outcome Measures
Rate and extent of absorption of TMC435 and ciprofloxacin in the blood circulation
Number of participants with Adverse Events as measures for Safety and Tolerability..
Number of Adverse Events (per type) as measures for Safety and Tolerability.
Results of clinical laboratory evaluations as measures for Safety and Tolerability.
Vital signs including ECG monitoring as measures for Safety and Tolerability.
Full Information
NCT ID
NCT01124799
First Posted
May 13, 2010
Last Updated
May 3, 2013
Sponsor
Tibotec Pharmaceuticals, Ireland
1. Study Identification
Unique Protocol Identification Number
NCT01124799
Brief Title
TMC435-TiDP16-C125 - Study in Healthy Volunteers to Evaluate the Potential of TMC435 to Increase the Sensitivity of the Skin Towards Exposure to Sun Light
Official Title
Photosensitivity Trial. A Randomized, Double-blind, Double Dummy, Placebo- and Positive Controlled Phase I Trial to Evaluate the Photosensitizing Potential of TMC435 in Healthy Subjects.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tibotec Pharmaceuticals, Ireland
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to evaluate the potential effect of TMC435 on the sensitivity of the skin towards exposure to sunlight. TMC435 is a drug that is currently under development for treatment of chronic hepatitis C virus infection. This study will be conducted in healthy volunteers. Ciprofloxacin, a commonly used antibiotic, is used as a positive control as this drug is known to mildly increase skin sensitivity to exposure to sunlight. This study also evaluates the levels of TMC435 and ciprofloxacin in the blood circulation and the safety and tolerability of TMC435.
Detailed Description
This is a randomized (study drug assigned by chance), double blind (neither the study doctor, nor medical staff nor the healthy volunteer know the name of the assigned drug), double-dummy (all healthy volunteers take the same number of identically looking capsules, independent of the drug they have been assigned to), placebo- and positive-controlled (ciprofloxacin is a drug known to cause a mild photosensitive response) study. A total of 36 healthy volunteers will participate. Participants will be assigned to take TMC435 (one dose between 75 and 150 mg, once a day), TMC435-placebo (once a day) or ciprofloxacin (500 mg twice a day). The aim of this study is to look at the reaction of the skin after exposure to artificial sunlight when taking TMC435, ciprofloxacin or placebo. Study drug will be administered for 9 days. Phototesting (area of skin on your back will be exposed to artificial sunlight) will be conducted during 3 days before intake of study medication starts and during 3 days (Days 8, 9 and 10) during treatment. Skin reactions, general tolerability and safety of TMC435 will be assessed throughout the trial period (or longer if needed). Blood and urine samples will be taken at screening, on day 1, day 7, day 10 and at 2 follow-up visits. Blood levels of TMC435 and ciprofloxacin will be determined on Day 1, 5, 6, 7 (16 times), 8 (twice), 9 (twice) and 10. ECG and vital signs will be taken at screening, on day 1, twice on day 7, on day 10 and at 2 follow-up visits. A physical examination will be done at screening, on day 1, day 10 and at both follow-up visits. Volunteers assigned to the TMC435 group will receive a morning oral dose (dose between 75 and 150 mg) of TMC435 and a noon and evening oral dose of placebo, for 9 consecutive days. Volunteers assigned to the placebo group will receive oral placebo doses in the morning, at noon and in the evening, for 9 consecutive days. Volunteers assigned to the ciprofloxacin group will receive an oral morning placebo dose and a noon and evening oral dose of 500 mg ciprofloxacin, for 9 consecutive days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus
Keywords
Hepatitis C virus, TMC435-TiDP16-C125, TMC435-C125, TMC435, TMC435350, protease inhibitor, HCV, Hepatitis C, photosensitivity, phototoxicity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
001
Arm Type
Experimental
Arm Description
TMC435 one morning TMC435 dose between 75 and 150 mg and a placebo dose at noon and in the evening for 9 days
Arm Title
002
Arm Type
Placebo Comparator
Arm Description
Placebo placebo dose in the morning at noon and in the evening for 9 days
Arm Title
003
Arm Type
Active Comparator
Arm Description
Ciprofloxacin one morning placebo dose and a noon and evening dose of ciprofloxacin 500 mg for 9 days
Intervention Type
Drug
Intervention Name(s)
TMC435
Intervention Description
one morning TMC435 dose between 75 and 150 mg and a placebo dose at noon and in the evening, for 9 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo dose in the morning, at noon and in the evening, for 9 days
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin
Intervention Description
one morning placebo dose and a noon and evening dose of ciprofloxacin 500 mg, for 9 days
Primary Outcome Measure Information:
Title
The effect of TMC435 versus placebo on the sensitivity of the skin towards sun light
Time Frame
Final phototesting assessment will be done on day 9 and 10 during medication intake.
Secondary Outcome Measure Information:
Title
Rate and extent of absorption of TMC435 and ciprofloxacin in the blood circulation
Time Frame
Determined on Day1, 5, 6, 7, 8, 9 and 10, with extensive pharmacokinetic testing on Day7.
Title
Number of participants with Adverse Events as measures for Safety and Tolerability..
Time Frame
Until last follow-up visit 30-35 days after last drug intake.
Title
Number of Adverse Events (per type) as measures for Safety and Tolerability.
Time Frame
Until last follow-up visit 30-35 days after last drug intake.
Title
Results of clinical laboratory evaluations as measures for Safety and Tolerability.
Time Frame
Until last follow-up visit 30-35 days after last drug intake.
Title
Vital signs including ECG monitoring as measures for Safety and Tolerability.
Time Frame
Until last follow-up visit 30-35 days after last drug intake.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Skin type I to III
No ultraviolet exposure on the back for 4 weeks prior to baseline phototesting
Normal skin response during baseline phototesting
Body Mass Index of 18.0 to 30.0 kg/m2
Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram.
Exclusion Criteria:
History of hypersensitivity to sunlight or artificial source of intense light, especially UV light
history or currently active porphyria or lupus erythematosus
Positive plasma porphyrin scan and lupus erythematosus antibodies
Active skin disorders on the back where phototesting will be performed
Infection with Hepatitis A, B or C virus
Infection with the human immunodeficiency virus (HIV)
Women who are pregnant or breastfeeding
History of or any current medical condition which could impact the safety of the participant in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tibotec Pharmaceuticals Clinical Trial
Organizational Affiliation
Tibotec Pharmaceutical Limited
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
TMC435-TiDP16-C125 - Study in Healthy Volunteers to Evaluate the Potential of TMC435 to Increase the Sensitivity of the Skin Towards Exposure to Sun Light
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