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
Information source: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis C Virus
Intervention: TMC435 (Drug); Placebo (Drug); Ciprofloxacin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Tibotec Pharmaceuticals, Ireland Official(s) and/or principal investigator(s): Tibotec Pharmaceuticals Clinical Trial, Study Director, Affiliation: Tibotec Pharmaceutical Limited
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: The effect of TMC435 versus placebo on the sensitivity of the skin towards sun light
Secondary outcome: Rate and extent of absorption of TMC435 and ciprofloxacin in the blood circulationNumber 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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: July 2010
Last updated: May 3, 2013
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