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

NCT01124799 | Completed Phase 1

• 1 other identifier: CR017158
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis C Virus

Keywords

Hepatitis C virus; TMC435-TiDP16-C125; TMC435-C125; TMC435; TMC435350; protease inhibitor; HCV; Hepatitis C; photosensitivity; phototoxicity

Outcome Measures

Primary Outcomes (1)

• The effect of TMC435 versus placebo on the sensitivity of the skin towards sun light

  Final phototesting assessment will be done on day 9 and 10 during medication intake.

Secondary Outcomes (5)

• Rate and extent of absorption of TMC435 and ciprofloxacin in the blood circulation

  Determined on Day1, 5, 6, 7, 8, 9 and 10, with extensive pharmacokinetic testing on Day7.

• Number of participants with Adverse Events as measures for Safety and Tolerability..

  Until last follow-up visit 30-35 days after last drug intake.

• Number of Adverse Events (per type) as measures for Safety and Tolerability.

  Until last follow-up visit 30-35 days after last drug intake.

• Results of clinical laboratory evaluations as measures for Safety and Tolerability.

  Until last follow-up visit 30-35 days after last drug intake.

• Vital signs including ECG monitoring as measures for Safety and Tolerability.

  Until last follow-up visit 30-35 days after last drug intake.

Study Arms (3)

001

EXPERIMENTAL

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

002

PLACEBO COMPARATOR

Placebo placebo dose in the morning at noon and in the evening for 9 days

Drug: Placebo

003

ACTIVE COMPARATOR

Ciprofloxacin one morning placebo dose and a noon and evening dose of ciprofloxacin 500 mg for 9 days

Drug: Ciprofloxacin

Interventions

TMC435 DRUG

one morning TMC435 dose between 75 and 150 mg and a placebo dose at noon and in the evening, for 9 days

001

Placebo DRUG

placebo dose in the morning, at noon and in the evening, for 9 days

002

Ciprofloxacin DRUG

one morning placebo dose and a noon and evening dose of ciprofloxacin 500 mg, for 9 days

003

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

MeSH Terms

Conditions

Hepatitis C; Photosensitivity Disorders; Dermatitis, Phototoxic

Interventions

Simeprevir; Ciprofloxacin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Dermatitis, Irritant; Dermatitis, Contact; Dermatitis; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring

Study Officials

• Tibotec Pharmaceuticals Clinical Trial

  Tibotec Pharmaceutical Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2010
• First Posted: May 17, 2010
• Study Start: July 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 6, 2013

Record last verified: 2013-05