Hepatitis C VirusPhase 1NCT01124799
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
A Phase 1 study testing TMC435 and Ciprofloxacin in people with Hepatitis C Virus, run by Tibotec Pharmaceuticals, Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C Virus
- What is being tested?
- TMC435 and Ciprofloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Apr 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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.
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.
Read the 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.
- Conditions
- Hepatitis C Virus
- Being tested
- TMC435, Placebo, Ciprofloxacin
- Keywords
- Hepatitis C virus, TMC435-TiDP16-C125, TMC435-C125, TMC435, TMC435350, protease inhibitor, HCV, Hepatitis C, photosensitivity, phototoxicity
- Medical subject headings
- Hepatitis C, Photosensitivity Disorders, Dermatitis, Phototoxic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMC435Drug
one morning TMC435 dose between 75 and 150 mg and a placebo dose at noon and in the evening, for 9 days
PlaceboDrug
placebo dose in the morning, at noon and in the evening, for 9 days
CiprofloxacinDrug
one morning placebo dose and a noon and evening dose of ciprofloxacin 500 mg, for 9 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: TMC435 |
| 002 | Placebo comparator | Placebo placebo dose in the morning at noon and in the evening for 9 days Receives: Drug: Placebo |
| 003 | Active comparator | Ciprofloxacin one morning placebo dose and a noon and evening dose of ciprofloxacin 500 mg for 9 days Receives: Drug: Ciprofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of TMC435 versus placebo on the sensitivity of the skin towards sun light
Measured: 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
Measured: 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..
Measured: Until last follow-up visit 30-35 days after last drug intake.
Number of Adverse Events (per type) as measures for Safety and Tolerability.
Measured: Until last follow-up visit 30-35 days after last drug intake.
Results of clinical laboratory evaluations as measures for Safety and Tolerability.
Measured: Until last follow-up visit 30-35 days after last drug intake.
Vital signs including ECG monitoring as measures for Safety and Tolerability.
Measured: Until last follow-up visit 30-35 days after last drug intake.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tibotec Pharmaceuticals, Ireland
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tibotec Pharmaceuticals Clinical Trial, Study director, Tibotec Pharmaceutical Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124799
- Sponsor's protocol ID
- CR017158
- Status last verified
- May 2013
- First submitted
- 13 May 2010
- Last updated
- 6 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01124799
- Acronym / sponsor ID
- CR017158
- Conditions
- Hepatitis C Virus
- Keywords
- Hepatitis C virus, TMC435-TiDP16-C125, TMC435-C125, TMC435, TMC435350, protease inhibitor, HCV, Hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Tibotec Pharmaceuticals, IrelandIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 17 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: TMC435TMC435 one morning TMC435 dose between 75 and 150 mg and a placebo dose at noon and in the evening for 9 days |
| 002 | Placebo comparator | Drug: PlaceboPlacebo placebo dose in the morning at noon and in the evening for 9 days |
| 003 | Active comparator | Drug: CiprofloxacinCiprofloxacin one morning placebo dose and a noon and evening dose of ciprofloxacin 500 mg for 9 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMC435one morning TMC435 dose between 75 and 150 mg and a placebo dose at noon and in the evening, for 9 days | Drug | 001 |
| Placeboplacebo dose in the morning, at noon and in the evening, for 9 days | Drug | 002 |
| Ciprofloxacinone morning placebo dose and a noon and evening dose of ciprofloxacin 500 mg, for 9 days | Drug | 003 |
Primary outcome
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.
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tibotec Pharmaceuticals Clinical Trial study director
Tibotec Pharmaceutical Limited
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TMC435 and Ciprofloxacin in people with Hepatitis C Virus, run by Tibotec Pharmaceuticals, Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2013.