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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
Tibotec Pharmaceuticals, Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    May 13, 2010
    Last Updated
    May 3, 2013
    Sponsor
    Tibotec Pharmaceuticals, Ireland
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    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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