Hepatitis CPhase 1NCT01308606
TMC435-TiDP16-C116 - Relative Bioavailability and Food Effect Study
A Phase 1 study testing TMC435 HPMC capsule, TMC435 HPMC or gelatin capsule and TMC435 gelatin capsule in people with Hepatitis C, run by Tibotec Pharmaceuticals, Ireland.
Trial summary
The purpose of this study is to compare absorption of TMC435 formulated as 2 different types of capsules. After that, the absorption of one chosen TMC435 capsule will be compared when taken under fasting conditions or together with a standard or a high-fat meal. This will be done 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
- What is being tested?
- TMC435 HPMC capsule, TMC435 HPMC or gelatin capsule and TMC435 gelatin capsule
- 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
- Mar 2011to Jun 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
- Non-smokers for at least 3 months prior to screening
- Have a body mass index of 18.0 to 30.0 kg per square meter
- Be healthy on the basis of physical examination, medical history, vital signs, and clinical laboratory tests performed at screening
Who cannot join
- Use of disallowed therapies, including over-the-counter products and dietary supplements
- Having previously participated in a multiple-dose trial or more than 3 single-dose trials with TMC435
- Received an investigational drug or used an investigational medical device within 90 days before the planned start of treatment
- History or evidence of current use of alcohol, barbiturate, amphetamine, recreational, or narcotic drug use
About this study
Official title: A Phase I, Open-label, Randomized, Single-dose, 2-panel, Crossover Trial in Healthy Subjects to Assess the Relative Bioavailability of TMC435 HPMC Capsule Compared to the TMC435 Gelatin Capsule and to Assess the Effect of Different Meal Types on the Bioavailability of Both Formulations
The purpose of this study is to compare absorption of TMC435 formulated as 2 different types of capsules. After that, the absorption of one chosen TMC435 capsule will be compared when taken under fasting conditions or together with a standard or a high-fat meal. This will be done in healthy volunteers.
Read the detailed description
This is an open-label, randomized, single-dose, crossover trial in healthy volunteers. Crossover means that participants may receive different interventions sequentially during the trial. Randomized means that you will be assigned to a treatment sequence by chance, like flipping a coin. Open-label means that you and your physician will know what treatment you will receive. The study will consist of 3 phases: a screening phase, a treatment phase and a follow-up phase. Total study duration for an individual participant will be up to 6 or 7 weeks. Once found eligible after the screening phase, participants will take part in one of the two parts of the treatment phase. In the first part, a group of 24 participants will receive two treatment sessions, A and B. The order in which the treatments are given will be determined by chance. Treatment A is a single dose of TMC345 as one formulation (1 capsule). Treatment B is a single dose of TMC435 as another formulation (1 other type of capsule). Both treatments will be taken without food. In between the 2 sessions, there will be at least 7 days. In the second part, another group of 24 participants will receive 3 treatment sessions, C, D, and E. The order in which these treatments are given will be determined by chance. All 3 treatments will consist of a single dose of TMC435 as one of the 2 formulations given in the first part. In Treatment C this will be given without food, in Treatment D with a standardized breakfast and in Treatment E with a high-fat breakfast. In between the sessions, there will be at least 7 days. For all treatment sessions, participants will enter the study center the day before dosing and will remain there until the evening of the day after. The 3 following mornings, participants will come back to the study center. Five to 7 days after dosing, participants will have a last follow-up visit at the study center (follow-up phase). During the study, safety will be monitored, and during the treatment phase, at specified timepoints, blood samples will be taken for pharmacokinetic evalutions (effect of the body on the drug). In every treatment session, a single oral 150 mg TMC435 capsule will be given. One formulation will be a gelatin capsule. The other formulation will be a hydroxypropylmethylcellulose (HPMC) capsule.
- Conditions
- Hepatitis C
- Being tested
- TMC435 HPMC capsule, TMC435 HPMC or gelatin capsule, TMC435 gelatin capsule
- Keywords
- TMC435-TiDP16-C116, TMC435-C116, TMC435, HCV, Hepatitis C, Hep C, healthy volunteers
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMC435 HPMC capsuleDrug
Single intake of one 150-mg capsule without food
TMC435 HPMC or gelatin capsuleDrug
Single intake of one 150-mg capsule after high-fat breakfast
TMC435 HPMC or gelatin capsuleDrug
Single intake of one 150-mg capsule without food
TMC435 HPMC or gelatin capsuleDrug
Single intake of one 150-mg capsule after standardized breakfast
TMC435 gelatin capsuleDrug
Single intake of one 150-mg capsule without food
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | TMC435 gelatin capsule Single intake of one 150-mg capsule without food Receives: Drug: TMC435 gelatin capsule |
| 002 | Experimental | TMC435 HPMC capsule Single intake of one 150-mg capsule without food Receives: Drug: TMC435 HPMC capsule |
| 003 | Experimental | TMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule without food Receives: Drug: TMC435 HPMC or gelatin capsule |
| 004 | Experimental | TMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule after standardized breakfast Receives: Drug: TMC435 HPMC or gelatin capsule |
| 005 | Experimental | TMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule after high-fat breakfast Receives: Drug: TMC435 HPMC or gelatin capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absorption of TMC435 following administration of the HPMC capsule and of the gelatin capsule
Measured: Over 72 hours for every treatment session
Absorption of TMC435 following administration of the HPMC or gelatin capsule in the fed (following different meal types) and fasted state
Measured: Over 72 hours for every treatment session
Secondary outcomes (5)
Number of participants with adverse events and the severity of adverse events
Measured: During maximum 7 weeks
Percentage of abnormal values for laboratory parameters
Measured: Up to maximum 7 weeks
Observed values and changes from baseline of cardiovascular variables
Measured: Up to maximum 7 weeks
Evaluation of pulse and blood pressure values, based on changes from baseline and the percentage of participants with values beyond clinically important limits
Measured: Up to maximum 7 weeks
Physical examination findings and changes from baseline.
Measured: Up to maximum 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startMar 2011
- Study completionJun 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
- 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
- NCT01308606
- Sponsor's protocol ID
- CR015940
- Other IDs
- TMC435-TiDP16-C116
- Status last verified
- Oct 2012
- First submitted
- 3 Mar 2011
- Last updated
- 11 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Randomized, Single-dose, 2-panel, Crossover Trial in Healthy Subjects to Assess the Relative Bioavailability of TMC435 HPMC Capsule Compared to the TMC435 Gelatin Capsule and to Assess the Effect of Different Meal Types on the Bioavailability of Both Formulations
- ClinicalTrials.gov ID
- NCT01308606
- Acronym / sponsor ID
- CR015940
- Conditions
- Hepatitis C
- Keywords
- TMC435-TiDP16-C116, TMC435-C116, TMC435, HCV, Hepatitis C, Hep C, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Tibotec Pharmaceuticals, IrelandIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Study completion
- Jun 2011 (actual)
- First posted
- 4 Mar 2011 (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 compare absorption of TMC435 formulated as 2 different types of capsules. After that, the absorption of one chosen TMC435 capsule will be compared when taken under fasting conditions or together with a standard or a high-fat meal. This will be done in healthy volunteers.
Detailed description
This is an open-label, randomized, single-dose, crossover trial in healthy volunteers. Crossover means that participants may receive different interventions sequentially during the trial. Randomized means that you will be assigned to a treatment sequence by chance, like flipping a coin. Open-label means that you and your physician will know what treatment you will receive. The study will consist of 3 phases: a screening phase, a treatment phase and a follow-up phase. Total study duration for an individual participant will be up to 6 or 7 weeks. Once found eligible after the screening phase, participants will take part in one of the two parts of the treatment phase. In the first part, a group of 24 participants will receive two treatment sessions, A and B. The order in which the treatments are given will be determined by chance. Treatment A is a single dose of TMC345 as one formulation (1 capsule). Treatment B is a single dose of TMC435 as another formulation (1 other type of capsule). Both treatments will be taken without food. In between the 2 sessions, there will be at least 7 days. In the second part, another group of 24 participants will receive 3 treatment sessions, C, D, and E. The order in which these treatments are given will be determined by chance. All 3 treatments will consist of a single dose of TMC435 as one of the 2 formulations given in the first part. In Treatment C this will be given without food, in Treatment D with a standardized breakfast and in Treatment E with a high-fat breakfast. In between the sessions, there will be at least 7 days. For all treatment sessions, participants will enter the study center the day before dosing and will remain there until the evening of the day after. The 3 following mornings, participants will come back to the study center. Five to 7 days after dosing, participants will have a last follow-up visit at the study center (follow-up phase). During the study, safety will be monitored, and during the treatment phase, at specified timepoints, blood samples will be taken for pharmacokinetic evalutions (effect of the body on the drug). In every treatment session, a single oral 150 mg TMC435 capsule will be given. One formulation will be a gelatin capsule. The other formulation will be a hydroxypropylmethylcellulose (HPMC) capsule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: TMC435 gelatin capsuleTMC435 gelatin capsule Single intake of one 150-mg capsule without food |
| 002 | Experimental | Drug: TMC435 HPMC capsuleTMC435 HPMC capsule Single intake of one 150-mg capsule without food |
| 003 | Experimental | Drug: TMC435 HPMC or gelatin capsuleTMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule without food |
| 004 | Experimental | Drug: TMC435 HPMC or gelatin capsuleTMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule after standardized breakfast |
| 005 | Experimental | Drug: TMC435 HPMC or gelatin capsuleTMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule after high-fat breakfast |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Non-smokers for at least 3 months prior to screening
- Have a body mass index of 18.0 to 30.0 kg per square meter
- Be healthy on the basis of physical examination, medical history, vital signs, and clinical laboratory tests performed at screening
Key exclusion criteria (4 listed)
- Use of disallowed therapies, including over-the-counter products and dietary supplements
- Having previously participated in a multiple-dose trial or more than 3 single-dose trials with TMC435
- Received an investigational drug or used an investigational medical device within 90 days before the planned start of treatment
- History or evidence of current use of alcohol, barbiturate, amphetamine, recreational, or narcotic drug use
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 |
|---|---|---|
| TMC435 HPMC capsuleSingle intake of one 150-mg capsule without food | Drug | 002 |
| TMC435 HPMC or gelatin capsuleSingle intake of one 150-mg capsule after high-fat breakfast | Drug | 005 |
| TMC435 HPMC or gelatin capsuleSingle intake of one 150-mg capsule without food | Drug | 003 |
| TMC435 HPMC or gelatin capsuleSingle intake of one 150-mg capsule after standardized breakfast | Drug | 004 |
| TMC435 gelatin capsuleSingle intake of one 150-mg capsule without food | Drug | 001 |
Primary outcome
Absorption of TMC435 following administration of the HPMC capsule and of the gelatin capsule
Time frame: Over 72 hours for every treatment session
Absorption of TMC435 following administration of the HPMC or gelatin capsule in the fed (following different meal types) and fasted state
Time frame: Over 72 hours for every treatment session
5 secondary outcomes
Number of participants with adverse events and the severity of adverse events
Time frame: During maximum 7 weeks
Percentage of abnormal values for laboratory parameters
Time frame: Up to maximum 7 weeks
Observed values and changes from baseline of cardiovascular variables
Time frame: Up to maximum 7 weeks
Evaluation of pulse and blood pressure values, based on changes from baseline and the percentage of participants with values beyond clinically important limits
Time frame: Up to maximum 7 weeks
Physical examination findings and changes from baseline.
Time frame: Up to maximum 7 weeks
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 11 Oct 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 HPMC capsule, TMC435 HPMC or gelatin capsule and TMC435 gelatin capsule in people with Hepatitis C, 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 4 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 11 Oct 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?
Absorption of TMC435 following administration of the HPMC capsule and of the gelatin capsule (time frame: Over 72 hours for every treatment session). 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 11 Oct 2012.