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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT01124799
First received: May 13, 2010
Last updated: May 3, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Hepatitis C Virus
Drug: TMC435
Drug: Placebo
Drug: Ciprofloxacin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Tibotec Pharmaceuticals, Ireland:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: July 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
TMC435 one morning TMC435 dose between 75 and 150 mg and a placebo dose at noon and in the evening for 9 days
Drug: TMC435
one morning TMC435 dose between 75 and 150 mg and a placebo dose at noon and in the evening, for 9 days
Placebo Comparator: 002
Placebo placebo dose in the morning at noon and in the evening for 9 days
Drug: Placebo
placebo dose in the morning, at noon and in the evening, for 9 days
Active Comparator: 003
Ciprofloxacin one morning placebo dose and a noon and evening dose of ciprofloxacin 500 mg for 9 days
Drug: Ciprofloxacin
one morning placebo dose and a noon and evening dose of ciprofloxacin 500 mg, for 9 days

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01124799

Sponsors and Collaborators
Tibotec Pharmaceuticals, Ireland
Investigators
Study Director: Tibotec Pharmaceuticals Clinical Trial Tibotec Pharmaceutical Limited
  More Information

No publications provided

Responsible Party: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier: NCT01124799     History of Changes
Other Study ID Numbers: CR017158
Study First Received: May 13, 2010
Last Updated: May 3, 2013
Health Authority: Ireland: Irish Agriculture and Food Development Authority
Great Britain: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Tibotec Pharmaceuticals, Ireland:
Hepatitis C virus
TMC435-TiDP16-C125
TMC435-C125
TMC435
TMC435350
protease inhibitor
HCV
Hepatitis C
photosensitivity
phototoxicity

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ciprofloxacin
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014