Hepatitis CPhase 1NCT01202825
TMC647055HPC1001 - First-in-human Trial to Examine Safety, Tolerability and Pharmacokinetics (How the Drug is Absorbed Into the Bloodstream) of Increasing Single Oral Doses and of Increasing Repeated Oral Doses of TMC647055 in Healthy Volunteers and in Hepatitis C Virus Infected Patients
A Phase 1 study testing TMC647055 and TMC435 in people with Hepatitis C, run by Tibotec Pharmaceuticals, Ireland at 1 site in Belgium.
Trial summary
The purpose of this study is to assess the safety and tolerability of TMC647055 both after increasing single oral doses from 100 mg up to maximum 3000 mg in fed conditions, and after multiple oral doses in fed conditions at increasing dose levels administered for 6 days, as well as to assess the pharmacokinetics of… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- TMC647055 and TMC435
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2010to Nov 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers should be healthy on the basis of physical examination, medical history, laboratory tests, triplicate electrocardiogram and vital signs, performed at screening, have a Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included and be non-smoking for at least 3 months prior to selection
- Chronic hepatitis-C infected patients should have documented chronic genotype 1a or 1b HCV infection, otherwise no clinically relevant currently active disease and a BMI of 18.0 to 35.0 kg/m2, extremes included
- Women must be postmenopausal for at least 2 years, and/or be surgically sterile.
Who cannot join
- All participants with a drug allergy such as, but not limited to, sulfonamides and penicillins, or with a drug allergy as witnessed in previous trials with experimental drugs
- Use of concomitant medication, including over-the-counter products, herbal medication and dietary supplements, except for paracetamol (acetaminophen) or ibuprofen or hormone replacement therapy or for chronic hepatitis-C infected patients products that are not CYP3A4 inhibitors or inducers and stable use of methadone, in a period of 14 days before the first trial medication administration
- Any condition that, in the opinion of the investigator, would compromise the study or the well-being of the subject or prevent the subject from meeting or performing study requirements
- History or suspicion of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator's opinion would compromise subject's safety and/or compliance with the trial procedures
- Participation in an investigational drug trial or having received an investigational vaccine within 30 days prior to the first intake of TMC647055 or placebo.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I, First-in-human Trial in Healthy Volunteers to Examine Increasing Single and Repeated Oral Doses of TMC647055, Followed by a Repeated-dose Part in Chronic HCV-genotype 1 Infected Patients to Examine TMC647055 Given Alone or in Combination With TMC435
The purpose of this study is to assess the safety and tolerability of TMC647055 both after increasing single oral doses from 100 mg up to maximum 3000 mg in fed conditions, and after multiple oral doses in fed conditions at increasing dose levels administered for 6 days, as well as to assess the pharmacokinetics of TMC647055 after increasing single oral doses from 100 mg up to maximum 3000 mg in fed conditions, and after multiple oral doses in fed conditions at increasing dose levels administered for 6 days and to assess the effect of food on a single oral dose of TMC647055 at one dose level, all in healthy participants. In addition, the safety, tolerability, pharmacokinetics and the antiviral activity of TMC647055 will be determined after 6 days of consecutive dosing and of TMC647055 and TMC435 after 10 days of co-administration in chronic hepatitis C virus infected patients. Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body. TMC647055 is being investigated for the treatment of chronic hepatitis C infection.
Read the detailed description
TMC647055 is being investigated for the treatment of chronic hepatitis C infection. This is a first-in-human, double-blind (sponsor, investigator and participant do not know which treatment is given), randomized (like flipping a coin), placebo-controlled, single centre, Phase I study in healthy volunteers to examine the safety, tolerability, and plasma pharmacokinetics of increasing single oral doses and of increasing repeated oral doses of TMC647055, followed by a double-blind repeated-dose part in chronic hepatitis C virus (HCV) infected patients. The study population will consist of 45 healthy adult volunteers between 18 and 55 years of age and 10 or 20 chronic HCV-genotype 1 infected patients between 18 and 65 years of age. The single dose escalation part of the trial will include 2 panels (Panels 1 and 2) of 9 participants each. There will be 6 sessions (Sessions I to VI): panel 1 will do sessions I, III \& V; panel 2 will do sessions II, IV and VI. In each session, 6 participants will receive TMC647055 and 3 participants will receive placebo with standard meals. Over 3 sessions, each participant will receive TMC647055 twice and placebo once. The dose of TMC647055 will be consecutively increased. Planned doses will be 100 mg, 250 mg, 600 mg, 1250 mg, 2000 mg, and 3000 mg of TMC647055 or placebo, administered as a single oral administration. A wash out period of at least 10 days will be respected between 2 sessions of 1 panel. Doses may be adapted pending the safety and pharmacokinetic outcome of the previous sessions but will not exceed the limit of 3000 mg. Dose increase will only occur if the previous dose is shown to be generally safe and tolerable. For precautionary safety reasons, the dose administration in sessions IV, V and VI will be staggered: the first 4 to 5 participants of the panel will receive the dose at least 24 hours prior to the second group of 4 to 5 participants. To investigate the effect of food, one single dose will be tested in fasted conditions (Session VII). The dose of TMC647055 tested in this session will be derived from the results obtained in Sessions I to V. Participants who received TMC647055 at the selected dose with standard meals in Sessions I to V will again receive TMC647055 in fasted conditions in Session VII. Participants who received placebo will receive placebo again. The multiple-dose escalation part of the trial (sessions VIII, IX and X) will include 3 panels (Panels 3, 4, and 5) of 9 participants each: panel 3 will do session VIII, panel 4 session IX and panel 5 session X. In all panels, TMC647055 or placebo will be administered during 6 consecutive days, with on Day 6 a morning dose only. Medication is anticipated to be given either every 8 hours, every 12 hours or every 24 hours. This can be changed per dosing session following the outcome of the previous session. In each multiple dosing session, 6 participants will receive TMC647055 and 3 participants will receive placebo. The multiple dose escalation part will be started when the doses of Sessions I, II, III, and IV are found to be generally safe and tolerable based upon review of the blinded safety and pharmacokinetic data. Dose increase will only occur if the previous dose is shown to be generally safe and tolerable. The initial daily dose tested in Panel 3 will not be higher than the doses tested in Sessions I to IV. After the healthy volunteer sessions, there will be 3 sessions in chronic HCV infected patients (sessions XI, XII and XIII). Session XI will be started when the doses in healthy volunteers are found to be generally safe and tolerable and a selected dose will be given every 12 hours. The total daily dose will not exceed the highest daily dose and exposure shown to be generally safe in the multiple dose escalation in healthy volunteers. The dose for session XII will be selected based on the results from session XI and will be given every 12 hours or every 8 hours. In each session, 8 patients will receive TMC647055 and 2 patients will receive placebo. TMC647055 will be given during 6 consecutive days with on day 6 a morning dose only. Session XIII will be open-label and will consist of 2 treatment arms. In treatment arm 1, 8 patients will receive TMC647055 (1000 mg twice a day) co-administered with TMC435 (150 mg once daily) for 10 days.In treatment arm 2, 8 subjects will receive TMC435 (150 mg once daily) for 6 days. Safety and tolerability will be evaluated continuously by checking illnesses and side effects, by taking blood and urine samples, by electrocardiograms and telemetry (electrical recording of the heart, only for healthy volunteers), by taking blood pressure and heart rate and by performing physical examinations. TMC647055 or placebo will be given as an oral solution, ranging from 100 to 3000 mg in the single dose part, in the multiple dose part during 6 consecutive days either every 8 hours, 12 hours or 24 hour. In sessions XI and XII, TMC647055 or placebo will be given every 8 or 12 hours at dose and frequency determined by results of the previous sessions. In session XIII, the dose of TMC647055 will be 1000 mg twice a day and TMC435 will be given as oral capsules at 150 mg once daily.
- Conditions
- Hepatitis C
- Being tested
- TMC647055, Placebo, TMC435
- Keywords
- HCV genotype 1 infected patients, TMC647055HPC1001, TMC647055, HPC, Hepatitis C, Healthy volunteers, TMC435
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMC647055Drug
One single dose as oral solution, doses from 100 mg up to a maximum of 3000 mg increasing in sessions I through VI.
PlaceboDrug
Oral solution given in session XI every 12 hours, in session XII every 12 or 8 hours. Doses and regimen will be determined based on outcome of previous sessions.
TMC647055Drug
Oral solution given in session XIII, treatment arm 1 during 10 days at a dose of 1000 mg every 12 hours.
TMC647055Drug
In sessions VIII through X, oral solution given once daily, every 12 hours or every 8 hours on 6 consecutive days. Doses are based on outcome of previous sessions.
PlaceboDrug
One single dose as oral solution, selected dose ranging between 100 and 3000 mg in session VII
TMC435Drug
Oral capsule given in session XIII, in treatment arm 1 during 10 days and in treatment arm 2 during 6 days at a dose of 150 mg once daily.
PlaceboDrug
One single dose as oral solution, selected dose ranging between 100 and 3000 mg in session VII
TMC647055Drug
One single dose as oral solution, selected dose ranging between 100 and 3000 mg in session VII
PlaceboDrug
In sessions VIII through X, oral solution given once daily, every 12 hours or every 8 hours on 6 consecutive days. Doses are based on outcome of previous sessions.
TMC647055Drug
Oral solution given in session XI every 12 hours, in session XII every 12 or 8 hours. Doses and regimen will be determined based on outcome of previous sessions.
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | Not described Receives: Drug: TMC647055 |
| 008 | Placebo comparator | Not described Receives: Drug: Placebo |
| 002 | Placebo comparator | Not described Receives: Drug: Placebo |
| 009 | Experimental | Not described Receives: Drug: TMC647055 |
| 003 | Experimental | Not described Receives: Drug: TMC647055 |
| 004 | Placebo comparator | Not described Receives: Drug: Placebo |
| 005 | Experimental | Not described Receives: Drug: TMC647055 |
| 010 | Experimental | Not described Receives: Drug: TMC435 |
| 006 | Placebo comparator | Not described Receives: Drug: Placebo |
| 007 | Experimental | Not described Receives: Drug: TMC647055 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with adverse events per type as a measure of safety and tolerability after increasing single and multiple oral doses in healthy volunteers.
Measured: Continuously from screening until the last follow-up visit 30 to 35 days after last drug intake.
Plasma and urine concentration of TMC647055 after increasing single and multiple oral doses in healthy volunteers in fed conditions.
Measured: For single dose sessions in plasma on days 1 (multiple times), 2 (2 times), 3 and 4 and continuous urine collection on days 1 and 2 of session IV only. For multiple dose sessions on days 1 and 6 multiple times, on day 7 2 times and on days 2-3-4-5-8-9.
Plasma concentration of TMC647055 after a single oral dose in healthy volunteers in fasted conditions as compaired to fed conditions.
Measured: For session 7, in plasma on days 1 (multiple timepoints), 2 (2 timepoints), 3 and 4.
Plasma concentration of TMC647055 after 6 days oral dosing in chronic HCV-genotype 1 infected patients.
Measured: On days 1 and 6 multiple times and on days 2-3-4-5-7-8-9 pre-dose.
The number of participants with adverse events per type as a measure of safety and tolerability after 6 days oral dosing in chronic HCV-genotype 1 infected patients.
Measured: Continuously from screening until the last follow-up visit 30 to 35 days after last drug intake.
Plasma concentration of TMC647055 after a single oral dose in healthy volunteers in fasted conditions as compared to fed conditions.
Measured: For session 7, in plasma on days 1 (multiple timepoints), 2 (2 timepoints), 3 and 4.
The number of participants with adverse events per type as a measure of safety and tolerability after 6 days of TMC647055, after 10 days co-administration of TMC647055 and TMC435 and after 6 days of TMC435 in chronic HCV-genotype 1 infected patients.
Measured: Continuously from screening until the last follow-up visit 30 to 35 days after last drug intake.
Plasma concentration of TMC647055 and TMC435, if applicable, in chronic HCV-genotype 1 infected patients.
Measured: Sessions XI and XII: on days 1 and 6 multiple times and on days 2-3-4-5-7-8-9 pre-dose. Session XIII: on days 1, 6 and 10 (if applicable) multiple times and on other days pre-dose.
Secondary outcomes (2)
HCV RNA decrease will be measured at the tested dose(s) and regimen(s) in chronic HCV-genotype 1 infected patients.
Measured: At screening, day 1 through day 9 at several timepoints.
HCV RNA will be measured in chronic HCV-genotype 1 infected patients.
Measured: Session XI and XII: at screening, day 1 through day 9 at several timepoints. Session XIII: at screening, day 1 through day 10 (TMC435 alone) or 14 (co-administration) at several timepoints and at the 3 follow-up visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startApr 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 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
- NCT01202825
- Sponsor's protocol ID
- CR017035
- Other IDs
- TMC647055HPC1001
- Status last verified
- Mar 2013
- First submitted
- 14 Sep 2010
- Last updated
- 4 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, First-in-human Trial in Healthy Volunteers to Examine Increasing Single and Repeated Oral Doses of TMC647055, Followed by a Repeated-dose Part in Chronic HCV-genotype 1 Infected Patients to Examine TMC647055 Given Alone or in Combination With TMC435
- ClinicalTrials.gov ID
- NCT01202825
- Acronym / sponsor ID
- CR017035
- Conditions
- Hepatitis C
- Keywords
- HCV genotype 1 infected patients, TMC647055HPC1001, TMC647055, HPC, Hepatitis C, Healthy volunteers, TMC435
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Tibotec Pharmaceuticals, IrelandIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 16 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 assess the safety and tolerability of TMC647055 both after increasing single oral doses from 100 mg up to maximum 3000 mg in fed conditions, and after multiple oral doses in fed conditions at increasing dose levels administered for 6 days, as well as to assess the pharmacokinetics of TMC647055 after increasing single oral doses from 100 mg up to maximum 3000 mg in fed conditions, and after multiple oral doses in fed conditions at increasing dose levels administered for 6 days and to assess the effect of food on a single oral dose of TMC647055 at one dose level, all in healthy participants. In addition, the safety, tolerability, pharmacokinetics and the antiviral activity of TMC647055 will be determined after 6 days of consecutive dosing and of TMC647055 and TMC435 after 10 days of co-administration in chronic hepatitis C virus infected patients. Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body. TMC647055 is being investigated for the treatment of chronic hepatitis C infection.
Detailed description
TMC647055 is being investigated for the treatment of chronic hepatitis C infection. This is a first-in-human, double-blind (sponsor, investigator and participant do not know which treatment is given), randomized (like flipping a coin), placebo-controlled, single centre, Phase I study in healthy volunteers to examine the safety, tolerability, and plasma pharmacokinetics of increasing single oral doses and of increasing repeated oral doses of TMC647055, followed by a double-blind repeated-dose part in chronic hepatitis C virus (HCV) infected patients. The study population will consist of 45 healthy adult volunteers between 18 and 55 years of age and 10 or 20 chronic HCV-genotype 1 infected patients between 18 and 65 years of age. The single dose escalation part of the trial will include 2 panels (Panels 1 and 2) of 9 participants each. There will be 6 sessions (Sessions I to VI): panel 1 will do sessions I, III \& V; panel 2 will do sessions II, IV and VI. In each session, 6 participants will receive TMC647055 and 3 participants will receive placebo with standard meals. Over 3 sessions, each participant will receive TMC647055 twice and placebo once. The dose of TMC647055 will be consecutively increased. Planned doses will be 100 mg, 250 mg, 600 mg, 1250 mg, 2000 mg, and 3000 mg of TMC647055 or placebo, administered as a single oral administration. A wash out period of at least 10 days will be respected between 2 sessions of 1 panel. Doses may be adapted pending the safety and pharmacokinetic outcome of the previous sessions but will not exceed the limit of 3000 mg. Dose increase will only occur if the previous dose is shown to be generally safe and tolerable. For precautionary safety reasons, the dose administration in sessions IV, V and VI will be staggered: the first 4 to 5 participants of the panel will receive the dose at least 24 hours prior to the second group of 4 to 5 participants. To investigate the effect of food, one single dose will be tested in fasted conditions (Session VII). The dose of TMC647055 tested in this session will be derived from the results obtained in Sessions I to V. Participants who received TMC647055 at the selected dose with standard meals in Sessions I to V will again receive TMC647055 in fasted conditions in Session VII. Participants who received placebo will receive placebo again. The multiple-dose escalation part of the trial (sessions VIII, IX and X) will include 3 panels (Panels 3, 4, and 5) of 9 participants each: panel 3 will do session VIII, panel 4 session IX and panel 5 session X. In all panels, TMC647055 or placebo will be administered during 6 consecutive days, with on Day 6 a morning dose only. Medication is anticipated to be given either every 8 hours, every 12 hours or every 24 hours. This can be changed per dosing session following the outcome of the previous session. In each multiple dosing session, 6 participants will receive TMC647055 and 3 participants will receive placebo. The multiple dose escalation part will be started when the doses of Sessions I, II, III, and IV are found to be generally safe and tolerable based upon review of the blinded safety and pharmacokinetic data. Dose increase will only occur if the previous dose is shown to be generally safe and tolerable. The initial daily dose tested in Panel 3 will not be higher than the doses tested in Sessions I to IV. After the healthy volunteer sessions, there will be 3 sessions in chronic HCV infected patients (sessions XI, XII and XIII). Session XI will be started when the doses in healthy volunteers are found to be generally safe and tolerable and a selected dose will be given every 12 hours. The total daily dose will not exceed the highest daily dose and exposure shown to be generally safe in the multiple dose escalation in healthy volunteers. The dose for session XII will be selected based on the results from session XI and will be given every 12 hours or every 8 hours. In each session, 8 patients will receive TMC647055 and 2 patients will receive placebo. TMC647055 will be given during 6 consecutive days with on day 6 a morning dose only. Session XIII will be open-label and will consist of 2 treatment arms. In treatment arm 1, 8 patients will receive TMC647055 (1000 mg twice a day) co-administered with TMC435 (150 mg once daily) for 10 days.In treatment arm 2, 8 subjects will receive TMC435 (150 mg once daily) for 6 days. Safety and tolerability will be evaluated continuously by checking illnesses and side effects, by taking blood and urine samples, by electrocardiograms and telemetry (electrical recording of the heart, only for healthy volunteers), by taking blood pressure and heart rate and by performing physical examinations. TMC647055 or placebo will be given as an oral solution, ranging from 100 to 3000 mg in the single dose part, in the multiple dose part during 6 consecutive days either every 8 hours, 12 hours or 24 hour. In sessions XI and XII, TMC647055 or placebo will be given every 8 or 12 hours at dose and frequency determined by results of the previous sessions. In session XIII, the dose of TMC647055 will be 1000 mg twice a day and TMC435 will be given as oral capsules at 150 mg once daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: TMC647055 |
| 008 | Placebo comparator | Drug: Placebo |
| 002 | Placebo comparator | Drug: Placebo |
| 009 | Experimental | Drug: TMC647055 |
| 003 | Experimental | Drug: TMC647055 |
| 004 | Placebo comparator | Drug: Placebo |
| 005 | Experimental | Drug: TMC647055 |
| 010 | Experimental | Drug: TMC435 |
| 006 | Placebo comparator | Drug: Placebo |
| 007 | Experimental | Drug: TMC647055 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteers should be healthy on the basis of physical examination, medical history, laboratory tests, triplicate electrocardiogram and vital signs, performed at screening, have a Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included and be non-smoking for at least 3 months prior to selection
- Chronic hepatitis-C infected patients should have documented chronic genotype 1a or 1b HCV infection, otherwise no clinically relevant currently active disease and a BMI of 18.0 to 35.0 kg/m2, extremes included
- Women must be postmenopausal for at least 2 years, and/or be surgically sterile.
Key exclusion criteria (5 listed)
- All participants with a drug allergy such as, but not limited to, sulfonamides and penicillins, or with a drug allergy as witnessed in previous trials with experimental drugs
- Use of concomitant medication, including over-the-counter products, herbal medication and dietary supplements, except for paracetamol (acetaminophen) or ibuprofen or hormone replacement therapy or for chronic hepatitis-C infected patients products that are not CYP3A4 inhibitors or inducers and stable use of methadone, in a period of 14 days before the first trial medication administration
- Any condition that, in the opinion of the investigator, would compromise the study or the well-being of the subject or prevent the subject from meeting or performing study requirements
- History or suspicion of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator's opinion would compromise subject's safety and/or compliance with the trial procedures
- Participation in an investigational drug trial or having received an investigational vaccine within 30 days prior to the first intake of TMC647055 or placebo.
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 |
|---|---|---|
| TMC647055One single dose as oral solution, doses from 100 mg up to a maximum of 3000 mg increasing in sessions I through VI. | Drug | 001 |
| PlaceboOral solution given in session XI every 12 hours, in session XII every 12 or 8 hours. Doses and regimen will be determined based on outcome of previous sessions. | Drug | 008 |
| TMC647055Oral solution given in session XIII, treatment arm 1 during 10 days at a dose of 1000 mg every 12 hours. | Drug | 009 |
| TMC647055In sessions VIII through X, oral solution given once daily, every 12 hours or every 8 hours on 6 consecutive days. Doses are based on outcome of previous sessions. | Drug | 005 |
| PlaceboOne single dose as oral solution, selected dose ranging between 100 and 3000 mg in session VII | Drug | 002 |
| TMC435Oral capsule given in session XIII, in treatment arm 1 during 10 days and in treatment arm 2 during 6 days at a dose of 150 mg once daily. | Drug | 010 |
| PlaceboOne single dose as oral solution, selected dose ranging between 100 and 3000 mg in session VII | Drug | 004 |
| TMC647055One single dose as oral solution, selected dose ranging between 100 and 3000 mg in session VII | Drug | 003 |
| PlaceboIn sessions VIII through X, oral solution given once daily, every 12 hours or every 8 hours on 6 consecutive days. Doses are based on outcome of previous sessions. | Drug | 006 |
| TMC647055Oral solution given in session XI every 12 hours, in session XII every 12 or 8 hours. Doses and regimen will be determined based on outcome of previous sessions. | Drug | 007 |
Primary outcome
The number of participants with adverse events per type as a measure of safety and tolerability after increasing single and multiple oral doses in healthy volunteers.
Time frame: Continuously from screening until the last follow-up visit 30 to 35 days after last drug intake.
Plasma and urine concentration of TMC647055 after increasing single and multiple oral doses in healthy volunteers in fed conditions.
Time frame: For single dose sessions in plasma on days 1 (multiple times), 2 (2 times), 3 and 4 and continuous urine collection on days 1 and 2 of session IV only. For multiple dose sessions on days 1 and 6 multiple times, on day 7 2 times and on days 2-3-4-5-8-9.
Plasma concentration of TMC647055 after a single oral dose in healthy volunteers in fasted conditions as compaired to fed conditions.
Time frame: For session 7, in plasma on days 1 (multiple timepoints), 2 (2 timepoints), 3 and 4.
Plasma concentration of TMC647055 after 6 days oral dosing in chronic HCV-genotype 1 infected patients.
Time frame: On days 1 and 6 multiple times and on days 2-3-4-5-7-8-9 pre-dose.
The number of participants with adverse events per type as a measure of safety and tolerability after 6 days oral dosing in chronic HCV-genotype 1 infected patients.
Time frame: Continuously from screening until the last follow-up visit 30 to 35 days after last drug intake.
Plasma concentration of TMC647055 after a single oral dose in healthy volunteers in fasted conditions as compared to fed conditions.
Time frame: For session 7, in plasma on days 1 (multiple timepoints), 2 (2 timepoints), 3 and 4.
The number of participants with adverse events per type as a measure of safety and tolerability after 6 days of TMC647055, after 10 days co-administration of TMC647055 and TMC435 and after 6 days of TMC435 in chronic HCV-genotype 1 infected patients.
Time frame: Continuously from screening until the last follow-up visit 30 to 35 days after last drug intake.
Plasma concentration of TMC647055 and TMC435, if applicable, in chronic HCV-genotype 1 infected patients.
Time frame: Sessions XI and XII: on days 1 and 6 multiple times and on days 2-3-4-5-7-8-9 pre-dose. Session XIII: on days 1, 6 and 10 (if applicable) multiple times and on other days pre-dose.
2 secondary outcomes
HCV RNA decrease will be measured at the tested dose(s) and regimen(s) in chronic HCV-genotype 1 infected patients.
Time frame: At screening, day 1 through day 9 at several timepoints.
HCV RNA will be measured in chronic HCV-genotype 1 infected patients.
Time frame: Session XI and XII: at screening, day 1 through day 9 at several timepoints. Session XIII: at screening, day 1 through day 10 (TMC435 alone) or 14 (co-administration) at several timepoints and at the 3 follow-up visits.
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 4 Mar 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TMC647055 and TMC435 in people with Hepatitis C, run by Tibotec Pharmaceuticals, Ireland at 1 site in Belgium.
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 4 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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 number of participants with adverse events per type as a measure of safety and tolerability after increasing single and multiple oral doses in healthy volunteers. (time frame: Continuously from screening until the last follow-up visit 30 to 35 days after last drug intake.). The study lists 8 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 4 Mar 2013.