Hepatitis C VirusPhase 1NCT01205139
TMC435-TiDP16-C114 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents TMC278 and Tenofovir
A Phase 1 study testing TMC435, TDF and TMC435 + TDF 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 on the steady-state pharmacokinetics of TMC278 or Tenofovir , 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… 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, TDF and TMC435 + TDF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Mar 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
- No-smoker for at least 3 months
- 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
- Infection with Hepatitis A, B or C Virus
- Infection with the Human Immunodeficiency Virus (HIV)
- History of, or any current medical condition which could impact the safety of the participant in the study
- Having previously participated in a multiple-dose trial with TMC435 and/or TMC278, or in a single- or multiple-dose trial with TMC278 long-acting
- Having previously participated in more than 3 single-dose trials with TMC435 and/or TMC278.
About this study
Official title: A Phase I, 2-panel, Open-label, Randomized, Cross-over Trial in Healthy Subjects to Investigate the Pharmacokinetic Interaction Between TMC435 and Antiretroviral Agents, TMC278 and Tenofovir Disoproxil Fumarate (TDF), at Steady State
The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 on the steady-state pharmacokinetics of TMC278 or Tenofovir , 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. TMC278 and Tenofovir are two antiretroviral drugs for treatment of human deficiency virus (HIV) 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). About 30% of all HIV infected patients are co-infected with HCV and need treatment for both infections. The results of this study will provide dosing recommendations for coadministration of TMC435 and TMC278 or Tenofovir in HCV-HCV co-infected patients. This is a Phase I, open-label (both participant and investigator know the name of the medication given at certain moment), randomized (sequence of treatment with study medications is assigned by chance), crossover trial in 48 healthy participants to investigate the pharmacokinetic interaction between TMC435 and an antiretroviral agent (TMC278 or tenofovir), at steady state. The participants are being allocated to one of two panels. In Panel 1, participants will receive three treatments (treatment A-B-C) in a randomized order. Participants will receive TMC435 150 mg q.d., TMC278 25 mg q.d.and TMC278 25 mg q.d. + TMC435 150 mg q.d., respectively. All treatments will be administered for 11 days and with food. There will be a washout period (a period where no study drug will be taken in view of having all the medication eliminated from the body before starting a new treatment) of at least 14 days between last intake of study medication in one session and first intake of study medication in the subsequent session. In Panel 2, participants will receive three treatments (treatment D-E-F) in a randomized order. Participants will receive TMC435 150 mg q.d., TDF 300 mg q.d. and TDF 300 mg q.d. + TMC435 150 mg q.d., respectively. All treatments will be administered for 7 days and with food. There will be a washout period of at least 7 days. Pharmacokinetic profiles of all three compounds will be determined through blood samples taken at regular intervals during the study. Safety and tolerability will be assessed during the study period and in follow-up. 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 11 and on Day 12 in each session of Panel 1, before medication intake on days 1 and 7 and on Day 8 in each session of Panel 2, 5 hours post dose on Day11 and Day 7 in Panel 1 and 2, respectively and at the 2 follow up visits at 1 week and 4-5 weeks after last dose of study medication in the last session. A physical examination will be performed at screening, on day -1 (= day before first medication intake in each session for both panels) and during the 2 follow up visits. Each volunteer will receive 3 treatments for 11 or 7 days (Panel 1 and 2, respectively), minimum 14 or 7 days apart from each other (Panel 1 and 2, respectively). Volunteers in Panel 1 will take oral TMC435 150 mg q.d., oral TMC278 25 mg q.d. and combined. Volunteers in Panel 2 will take oral TMC435 150 mg q.d., oral TDF 300 mg q.d. and combined.
- Conditions
- Hepatitis C Virus
- Being tested
- TMC435, TDF, TMC435 + TDF, TMC435 + TMC278, TMC278
- Keywords
- TMC435-TiDP16-C114, TMC435-C114, 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
150 mg capsule once daily for 7 days
TDFDrug
300 mg tablet once daily for 7 days
TMC435 + TDFDrug
150 mg TMC435 capsule + 300 mg TDF tablet, once daily for 7 days
TMC435 + TMC278Drug
150 mg TMC435 capsule + 25 mg TMC278 tablet, once daily for 11 days
TMC278Drug
25 mg tablet once daily for 11 days
TMC435Drug
150 mg capsule once daily for 11 days
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | TMC435 150 mg capsule once daily for 11 days Receives: Drug: TMC435 |
| 002 | Experimental | TMC278 25 mg tablet once daily for 11 days Receives: Drug: TMC278 |
| 003 | Experimental | TMC435 + TMC278 150 mg TMC435 capsule + 25 mg TMC278 tablet once daily for 11 days Receives: Drug: TMC435 + TMC278 |
| 004 | Experimental | TMC435 150 mg capsule once daily for 7 days Receives: Drug: TMC435 |
| 005 | Experimental | TDF 300 mg tablet once daily for 7 days Receives: Drug: TDF |
| 006 | Experimental | TMC435 + TDF 150 mg TMC435 capsule + 300 mg TDF tablet once daily for 7 days Receives: Drug: TMC435 + TDF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and extent of absorption of TMC435 following co-administration with TMC278 under fed condition, and vice versa.
Measured: Measured on Day1, 9, 10, 11 and 12 per treatment in Panel 1.
Rate and extent of absorption of TMC435 following co-administration with TDF under fed condition, and vice versa.
Measured: Measured on Day1, 5, 6, 7 and 8 per treatment in Panel 2.
Secondary outcomes (2)
Safety and tolerability following co-administration of TMC435 and TMC278 (Panel 1)
Measured: 89 to 94 days (till and including last safety follow-up visit) for Panel 1
Safety and tolerability following co-administration of TMC435 and TDF (Panel 2)
Measured: 63 to 68 days (till and including last safety follow-up visit) for Panel 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionMar 2011
- Study completionMar 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 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
- NCT01205139
- Sponsor's protocol ID
- CR017392
- Status last verified
- Nov 2012
- First submitted
- 16 Sep 2010
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, 2-panel, Open-label, Randomized, Cross-over Trial in Healthy Subjects to Investigate the Pharmacokinetic Interaction Between TMC435 and Antiretroviral Agents, TMC278 and Tenofovir Disoproxil Fumarate (TDF), at Steady State
- ClinicalTrials.gov ID
- NCT01205139
- Acronym / sponsor ID
- CR017392
- Conditions
- Hepatitis C Virus
- Keywords
- TMC435-TiDP16-C114, TMC435-C114, TMC435, HCV, Hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Tibotec Pharmaceuticals, IrelandIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 20 Sep 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 on the steady-state pharmacokinetics of TMC278 or Tenofovir , 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. TMC278 and Tenofovir are two antiretroviral drugs for treatment of human deficiency virus (HIV) 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). About 30% of all HIV infected patients are co-infected with HCV and need treatment for both infections. The results of this study will provide dosing recommendations for coadministration of TMC435 and TMC278 or Tenofovir in HCV-HCV co-infected patients. This is a Phase I, open-label (both participant and investigator know the name of the medication given at certain moment), randomized (sequence of treatment with study medications is assigned by chance), crossover trial in 48 healthy participants to investigate the pharmacokinetic interaction between TMC435 and an antiretroviral agent (TMC278 or tenofovir), at steady state. The participants are being allocated to one of two panels. In Panel 1, participants will receive three treatments (treatment A-B-C) in a randomized order. Participants will receive TMC435 150 mg q.d., TMC278 25 mg q.d.and TMC278 25 mg q.d. + TMC435 150 mg q.d., respectively. All treatments will be administered for 11 days and with food. There will be a washout period (a period where no study drug will be taken in view of having all the medication eliminated from the body before starting a new treatment) of at least 14 days between last intake of study medication in one session and first intake of study medication in the subsequent session. In Panel 2, participants will receive three treatments (treatment D-E-F) in a randomized order. Participants will receive TMC435 150 mg q.d., TDF 300 mg q.d. and TDF 300 mg q.d. + TMC435 150 mg q.d., respectively. All treatments will be administered for 7 days and with food. There will be a washout period of at least 7 days. Pharmacokinetic profiles of all three compounds will be determined through blood samples taken at regular intervals during the study. Safety and tolerability will be assessed during the study period and in follow-up. 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 11 and on Day 12 in each session of Panel 1, before medication intake on days 1 and 7 and on Day 8 in each session of Panel 2, 5 hours post dose on Day11 and Day 7 in Panel 1 and 2, respectively and at the 2 follow up visits at 1 week and 4-5 weeks after last dose of study medication in the last session. A physical examination will be performed at screening, on day -1 (= day before first medication intake in each session for both panels) and during the 2 follow up visits. Each volunteer will receive 3 treatments for 11 or 7 days (Panel 1 and 2, respectively), minimum 14 or 7 days apart from each other (Panel 1 and 2, respectively). Volunteers in Panel 1 will take oral TMC435 150 mg q.d., oral TMC278 25 mg q.d. and combined. Volunteers in Panel 2 will take oral TMC435 150 mg q.d., oral TDF 300 mg q.d. and combined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: TMC435TMC435 150 mg capsule once daily for 11 days |
| 002 | Experimental | Drug: TMC278TMC278 25 mg tablet once daily for 11 days |
| 003 | Experimental | Drug: TMC435 + TMC278TMC435 + TMC278 150 mg TMC435 capsule + 25 mg TMC278 tablet once daily for 11 days |
| 004 | Experimental | Drug: TMC435TMC435 150 mg capsule once daily for 7 days |
| 005 | Experimental | Drug: TDFTDF 300 mg tablet once daily for 7 days |
| 006 | Experimental | Drug: TMC435 + TDFTMC435 + TDF 150 mg TMC435 capsule + 300 mg TDF tablet once daily for 7 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- No-smoker for at least 3 months
- 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 (5 listed)
- Infection with Hepatitis A, B or C Virus
- Infection with the Human Immunodeficiency Virus (HIV)
- History of, or any current medical condition which could impact the safety of the participant in the study
- Having previously participated in a multiple-dose trial with TMC435 and/or TMC278, or in a single- or multiple-dose trial with TMC278 long-acting
- Having previously participated in more than 3 single-dose trials with TMC435 and/or TMC278.
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 |
|---|---|---|
| TMC435150 mg capsule once daily for 7 days | Drug | 004 |
| TDF300 mg tablet once daily for 7 days | Drug | 005 |
| TMC435 + TDF150 mg TMC435 capsule + 300 mg TDF tablet, once daily for 7 days | Drug | 006 |
| TMC435 + TMC278150 mg TMC435 capsule + 25 mg TMC278 tablet, once daily for 11 days | Drug | 003 |
| TMC27825 mg tablet once daily for 11 days | Drug | 002 |
| TMC435150 mg capsule once daily for 11 days | Drug | 001 |
Primary outcome
Rate and extent of absorption of TMC435 following co-administration with TMC278 under fed condition, and vice versa.
Time frame: Measured on Day1, 9, 10, 11 and 12 per treatment in Panel 1.
Rate and extent of absorption of TMC435 following co-administration with TDF under fed condition, and vice versa.
Time frame: Measured on Day1, 5, 6, 7 and 8 per treatment in Panel 2.
2 secondary outcomes
Safety and tolerability following co-administration of TMC435 and TMC278 (Panel 1)
Time frame: 89 to 94 days (till and including last safety follow-up visit) for Panel 1
Safety and tolerability following co-administration of TMC435 and TDF (Panel 2)
Time frame: 63 to 68 days (till and including last safety follow-up visit) for Panel 2
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 27 Nov 2012.
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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, TDF and TMC435 + TDF 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 3 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 27 Nov 2012. 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?
Rate and extent of absorption of TMC435 following co-administration with TMC278 under fed condition, and vice versa. (time frame: Measured on Day1, 9, 10, 11 and 12 per treatment in Panel 1.). The study lists 2 primary outcomes in all. 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 27 Nov 2012.