Hepatitis C VirusPhase 1NCT01090700
TMC435-TiDP16-C112 - Interaction Trial With Antidepressants
A Phase 1 study testing TMC435, Escitalopram and TMC435 + Escitalopram in people with Hepatitis C Virus, run by Tibotec Pharmaceuticals, Ireland.
Trial summary
The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 150mg q.d. (once a day) on the steady-state pharmacokinetics of escitalopram 10 mg q.d., and vice versa. 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, Escitalopram and TMC435 + Escitalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Sep 2010
- 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
- Non-smokers for at least 3 months prior to screening
- Healthy on the basis of physical examination, medical history, vital signs and 12-lead ECG performed at screening
- Healthy on the basis of clinical laboratory tests performed at screening
- Subjects must have signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study
- Participants must have signed the ICF for pharmacogenetic research indicating willingness to participate in the pharmacogenetic component of the study.
Who cannot join
- A positive human immunodeficiency virus - type 1 (HIV-1) or HIV-2 test at study screening
- Hepatitis A, B, or C infection (confirmed by hepatitis A antibody immunoglobulin [IgM], hepatitis B surface antigen, or hepatitis C virus antibody, respectively) at screening
- History of liver or renal (estimated creatinine clearance below 60 mL/min) insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric and neoplastic or metabolic disturbances
- Known allergies, hypersensitivity, or intolerance to TMC435 or its excipients
- Received an investigational drug (including investigational vaccines) or used an investigational medical device within 60 days before the planned start of treatment
About this study
Official title: A Phase I, Open-label, Randomized, 3-way Crossover Trial in Healthy Subjects to Investigate the Pharmacokinetic Interaction Between TMC435 and Escitalopram at Steady-state
The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 150mg q.d. (once a day) on the steady-state pharmacokinetics of escitalopram 10 mg q.d., and vice versa. Steady state is a term which means that the drug has been given long enough so that the plasma concentrations will remain the same with each subsequent dose. TMC435 is being investigated for the treatment of chronic hepatitis C virus (HCV) infection. Pharmacokinetics (pk) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.
Read the detailed description
TMC435 is being investigated for treatment of chronic HCV infection, in combination with Peg-IFN (pegylated interferon) and RBV (ribavirin). Peg-IFN plus RBV are currently an accepted methods for treating HCV. Treatment with Peg-IFN plus RBV for HCV infection is associated with a high rate of depression. The results of this study will provide dosing recommendations for coadministration of TMC435 and escitalopram in HCV-infected patients. This is a Phase I, open-label (both participant and investigator know the name of the medication) , randomized (study medication assigned by chance), crossover trial in 18 healthy participants to investigate the pharmacokinetic interaction between escitalopram and TMC435, both at steady state. Steady state is a term which means that the drug has been given long enough so that the plasma concentrations will remain the same with each subsequent dose. The participants will receive three treatments (treatment A-B-C) in a randomized order. In Treatment A, participants will receive TMC435 150 mg q.d. In Treatment B, participants will receive escitalopram 10 mg q.d. In treatment C, participants will receive escitalopram 10 mg q.d. and TMC435 150 mg q.d. All treatments will be administered for 7 days and with food. There will be a washout period (a period where no treatment will be taken in view of having all the medication eliminated from the body before starting a new treatment) of at least 10 days between last intake of study medication in one session and first intake of study medication in the subsequent session. Pharmacokinetic profiles of the two compounds will be measured through blood samples taken at regular intervals during the study and safety and tolerability will be assessed during the study period and in follow-up. Safety and tolerability evaluations will be recorded at regular intervals throughout the trial period. Blood and urine samples, electrocardiogram (ECG) and vital signs (blood pressure and heart rate) will be taken at screening, before medication intake on days 1 and 7 and on Day 8 in each session and at the 2 follow up visits at 1 week and 4-5 weeks after last dose of drug in the last session. A physical examination will be performed at screening, on day -1 (= day before day of first medication intake in each session) and during the 2 follow up visits. On the morning before first medication intake (in the first session only) a blood sample will be taken to examine your CYP2C19 genes, which are responsible for the production of enzymes that determine the breakdown of drugs in your body. The results of this study will provide dosing recommendations for coadministration of TMC435 and escitalopram in HCV-infected patients. Participants will receive in treatment A TMC435 150 mg q.d., in treatment B participants will receive escitalopram 10 mg and in treatment C participants will receive escitalopram 10 mg q.d. + TMC435 150 mg q.d. All treatments will be administered for 7 days and with food.
- Conditions
- Hepatitis C Virus
- Being tested
- TMC435, Escitalopram, TMC435 + Escitalopram
- Keywords
- TMC435-TiDP16-C112, TMC435-C112, TMC435, HCV, Hepatitis C
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMC435Drug
TMC435 150 mg daily for 7 days
EscitalopramDrug
Escitalopram 10 mg daily for 7 days
TMC435 + EscitalopramDrug
TMC435 150 mg + escitalopram 10 mg daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | TMC435 TMC435 150 mg daily for 7 days Receives: Drug: TMC435 |
| 002 | Other | Escitalopram Escitalopram 10 mg daily for 7 days Receives: Drug: Escitalopram |
| 003 | Experimental | TMC435 + Escitalopram TMC435 150 mg + escitalopram 10 mg daily for 7 days Receives: Drug: TMC435 + Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the effect of stable blood levels of TMC 435 given 150 mg q.d. on the stable blood levels of escitalopram given 10 mg q.d. in healthy participants and vica versa.
Measured: pk profiles of TMC435 will be measured up to 24 hours on Day 7 in Treatment A and C. Pharmacokinetic profiles of escitalopram will be measured up to 24 hours postdose on Day 7 of Treatment B and C.
Secondary outcomes (1)
The short-term safety and tolerability of coadministration of TMC435 and escitalopram in healthy participants (safety and tolerability criteria are the activity of the heart, blood pressure, pulse, physical examination, parameters in urine and blood)
Measured: This will be determined throughout the study; Day-1 through Day 8 in each session, 1 week and 4-5 weeks after last medication intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2010
- Study completionSep 2010
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT01090700
- Sponsor's protocol ID
- CR017044
- Status last verified
- Apr 2013
- First submitted
- 11 Mar 2010
- Last updated
- 9 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Randomized, 3-way Crossover Trial in Healthy Subjects to Investigate the Pharmacokinetic Interaction Between TMC435 and Escitalopram at Steady-state
- ClinicalTrials.gov ID
- NCT01090700
- Acronym / sponsor ID
- CR017044
- Conditions
- Hepatitis C Virus
- Keywords
- TMC435-TiDP16-C112, TMC435-C112, TMC435, HCV, Hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tibotec Pharmaceuticals, IrelandIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 22 Mar 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 this study is to investigate the effect of steady-state concentrations of TMC435 150mg q.d. (once a day) on the steady-state pharmacokinetics of escitalopram 10 mg q.d., and vice versa. Steady state is a term which means that the drug has been given long enough so that the plasma concentrations will remain the same with each subsequent dose. TMC435 is being investigated for the treatment of chronic hepatitis C virus (HCV) infection. Pharmacokinetics (pk) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.
Detailed description
TMC435 is being investigated for treatment of chronic HCV infection, in combination with Peg-IFN (pegylated interferon) and RBV (ribavirin). Peg-IFN plus RBV are currently an accepted methods for treating HCV. Treatment with Peg-IFN plus RBV for HCV infection is associated with a high rate of depression. The results of this study will provide dosing recommendations for coadministration of TMC435 and escitalopram in HCV-infected patients. This is a Phase I, open-label (both participant and investigator know the name of the medication) , randomized (study medication assigned by chance), crossover trial in 18 healthy participants to investigate the pharmacokinetic interaction between escitalopram and TMC435, both at steady state. Steady state is a term which means that the drug has been given long enough so that the plasma concentrations will remain the same with each subsequent dose. The participants will receive three treatments (treatment A-B-C) in a randomized order. In Treatment A, participants will receive TMC435 150 mg q.d. In Treatment B, participants will receive escitalopram 10 mg q.d. In treatment C, participants will receive escitalopram 10 mg q.d. and TMC435 150 mg q.d. All treatments will be administered for 7 days and with food. There will be a washout period (a period where no treatment will be taken in view of having all the medication eliminated from the body before starting a new treatment) of at least 10 days between last intake of study medication in one session and first intake of study medication in the subsequent session. Pharmacokinetic profiles of the two compounds will be measured through blood samples taken at regular intervals during the study and safety and tolerability will be assessed during the study period and in follow-up. Safety and tolerability evaluations will be recorded at regular intervals throughout the trial period. Blood and urine samples, electrocardiogram (ECG) and vital signs (blood pressure and heart rate) will be taken at screening, before medication intake on days 1 and 7 and on Day 8 in each session and at the 2 follow up visits at 1 week and 4-5 weeks after last dose of drug in the last session. A physical examination will be performed at screening, on day -1 (= day before day of first medication intake in each session) and during the 2 follow up visits. On the morning before first medication intake (in the first session only) a blood sample will be taken to examine your CYP2C19 genes, which are responsible for the production of enzymes that determine the breakdown of drugs in your body. The results of this study will provide dosing recommendations for coadministration of TMC435 and escitalopram in HCV-infected patients. Participants will receive in treatment A TMC435 150 mg q.d., in treatment B participants will receive escitalopram 10 mg and in treatment C participants will receive escitalopram 10 mg q.d. + TMC435 150 mg q.d. All treatments will be administered for 7 days and with food.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: TMC435TMC435 TMC435 150 mg daily for 7 days |
| 002 | Other | Drug: EscitalopramEscitalopram Escitalopram 10 mg daily for 7 days |
| 003 | Experimental | Drug: TMC435 + EscitalopramTMC435 + Escitalopram TMC435 150 mg + escitalopram 10 mg daily for 7 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Non-smokers for at least 3 months prior to screening
- Healthy on the basis of physical examination, medical history, vital signs and 12-lead ECG performed at screening
- Healthy on the basis of clinical laboratory tests performed at screening
- Subjects must have signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study
- Participants must have signed the ICF for pharmacogenetic research indicating willingness to participate in the pharmacogenetic component of the study.
Key exclusion criteria (5 listed)
- A positive human immunodeficiency virus - type 1 (HIV-1) or HIV-2 test at study screening
- Hepatitis A, B, or C infection (confirmed by hepatitis A antibody immunoglobulin [IgM], hepatitis B surface antigen, or hepatitis C virus antibody, respectively) at screening
- History of liver or renal (estimated creatinine clearance below 60 mL/min) insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric and neoplastic or metabolic disturbances
- Known allergies, hypersensitivity, or intolerance to TMC435 or its excipients
- Received an investigational drug (including investigational vaccines) or used an investigational medical device within 60 days before the planned start of treatment
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 |
|---|---|---|
| TMC435TMC435 150 mg daily for 7 days | Drug | 001 |
| EscitalopramEscitalopram 10 mg daily for 7 days | Drug | 002 |
| TMC435 + EscitalopramTMC435 150 mg + escitalopram 10 mg daily for 7 days | Drug | 003 |
Primary outcome
To investigate the effect of stable blood levels of TMC 435 given 150 mg q.d. on the stable blood levels of escitalopram given 10 mg q.d. in healthy participants and vica versa.
Time frame: pk profiles of TMC435 will be measured up to 24 hours on Day 7 in Treatment A and C. Pharmacokinetic profiles of escitalopram will be measured up to 24 hours postdose on Day 7 of Treatment B and C.
1 secondary outcome
The short-term safety and tolerability of coadministration of TMC435 and escitalopram in healthy participants (safety and tolerability criteria are the activity of the heart, blood pressure, pulse, physical examination, parameters in urine and blood)
Time frame: This will be determined throughout the study; Day-1 through Day 8 in each session, 1 week and 4-5 weeks after last medication 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 9 Apr 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, Escitalopram and TMC435 + Escitalopram 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 5 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 9 Apr 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. 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?
To investigate the effect of stable blood levels of TMC 435 given 150 mg q.d. on the stable blood levels of escitalopram given 10 mg q.d. in healthy participants and vica versa. (time frame: pk profiles of TMC435 will be measured up to 24 hours on Day 7 in Treatment A and C. Pharmacokinetic profiles of escitalopram will be measured up to 24 hours postdose on Day 7 of Treatment B and C.). 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 9 Apr 2013.