Healthy VolunteersPhase 1NCT01571570
A Study to Assess Bioavailability & Food Effect of Different Liquid and Capsule Formulations of TMC435.
A Phase 1 study testing TMC435 150 mg capsule, TMC435 150 mg oral suspension (20 mg/mL) and TMC435 150 mg oral solution (10 mg/mL) in people with Healthy Volunteers, run by Janssen R&D Ireland at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the relative bioavailability and the short-term safety and tolerability of TMC435 following administration of 3 single oral doses of 150 mg, given as different formulations in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TMC435 150 mg capsule, TMC435 150 mg oral suspension (20 mg/mL) and TMC435 150 mg oral solution (10 mg/mL)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2012to May 2012
- 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
- Healthy volunteers should be healthy on the basis of physical examination, medical history, laboratory tests, 12-lead 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 screening.
- Women must be postmenopausal for at least 2 years and/or surgically sterile or not heterosexually active for duration of the trial.
Who cannot join
- All participants with known allergies, hypersensitivity or intolerance to TMC435 or any of the excipients.
- Use of concomitant medication, including over the counter products, herbal medication and dietary supplements, except for paracetamol (acetaminophen) or ibuprofen.
- Any condition that, in the opinion of the investigator, would compromise the study or well-being of the participant 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 investigator's opinion would compromise participant's safety and/or compliance with the trial procedures.
- Participation in an investigational drug trial with TMC435.
- Infected with HIV or Hepatitic A, B or C.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-Label, Randomized, 3-Panel, 3-way Crossover Trial in Healthy Adult Subjects to Assess the Relative Bioavailability of TMC435 Following Administration of 2 Liquid Formulations or 2 Different Capsule Concept Formulations Compared ot the Phase III 150 mg Capsule, and to Assess the Effect of Food on the Bioavailability of TMC435 Following Administration of the Liquid Formulations.
The purpose of this study is to evaluate the relative bioavailability and the short-term safety and tolerability of TMC435 following administration of 3 single oral doses of 150 mg, given as different formulations in healthy adult participants. In addition, this study is to assess for the acceptability of the taste of both liquid formulations.
Read the detailed description
TMC435 is being investigated for the treatment of chronic hepatitis C infection. The current study is a Phase I, open-label (both participant and investigator know the name of the medication given at certain moment), randomized (study medication is assigned by chance) study designed to assess the relative bioavailability and food effect of 2 liquid formulations of TMC435, currently being developed for potential pediatric use, compared to the Phase III 150 mg capsule. Also new capsule concept formulations will be investigated in comparison with the Phase III 150 mg capsule. The study will be performed in healthy adult participants and is divided over 3 panels. Participants will be randomized within a panel. Each participant will receive 3 different treatments according to a classical 6-sequence, 3-period Williams design. In Panel 1 and Panel 2, a single oral dose of 150 mg TMC435 oral suspension respectively with other strength will be compared with the capsule used in Phase III. In Panel 3, two different capsule concept formulations will be compared with the capsule used in Phase III. In panels containing the liquids, formulations will be compared under fasted and fed conditions to investigate the food effect. In all treatments, the participants will receive medication on Day 1 of each treatment. There will be a washout period of at least 7 days between subsequent treatments. The main focus of the trial is the pharmacokinetic characteristics of all formulations (level-profile of TMC435 over time in the blood stream). This evaluation requires multiple blood samples from Day 1 till Day 4 in each treatment. Safety assessments (blood and urine tests, blood pressure, pulse, electrocardiogram, and physical examination) will follow a different schedule and will be evaluated from signing of the Informed Consent Form onwards until the last trial-related visit throughout the study.
- Conditions
- Healthy Volunteers
- Being tested
- TMC435 150 mg capsule, TMC435 150 mg oral suspension (20 mg/mL), TMC435 150 mg oral solution (10 mg/mL), TMC435 150 mg capsule concept K, TMC435 150 mg capsule concept L
- Keywords
- Healthy volunteers, Food effect, Capsule, Formulations, Liquid formulation, Concept K, Concept L, Oral suspension, Oral solution, TMC435HPC1002, TMC435, HPC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMC435 150 mg capsuleDrug
Also called TMC435
single oral dose of 150 mg TMC435 150 mg capsule
TMC435 150 mg oral suspension (20 mg/mL)Drug
Also called TMC435
single oral dose of 150 mg TMC435 oral suspension
TMC435 150 mg oral solution (10 mg/mL)Drug
Also called TMC435
single oral dose of 150 mg TMC435 oral solution
TMC435 150 mg capsule concept KDrug
Also called TMC435
single oral dose of 150 mg TMC435 capsule concept K
TMC435 150 mg capsule concept LDrug
Also called TMC435
single oral dose of 150 mg TMC435 capsule concept L
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Panel 1: single oral dose of 150 mg TMC435 150 mg capsule, fed Receives: Drug: TMC435 150 mg capsule |
| Treatment B | Experimental | Panel 1: single oral dose of 150 mg TMC435 oral suspension (20 mg/mL), fasted Receives: Drug: TMC435 150 mg oral suspension (20 mg/mL) |
| Treatment C | Experimental | Panel 1: single oral dose of 150 mg TMC435 oral suspension (20 mg/mL), fed Receives: Drug: TMC435 150 mg oral suspension (20 mg/mL) |
| Treatment D | Experimental | Panel 2: single oral dose of 150 mg TMC435 150 mg capsule, fed Receives: Drug: TMC435 150 mg capsule |
| Treatment E | Experimental | Panel 2: single oral dose of 150 mg TMC435 oral solution (10 mg/mL), fasted Receives: Drug: TMC435 150 mg oral solution (10 mg/mL) |
| Treatment F | Experimental | Panel 2: single oral dose of 150 mg TMC435 oral solution (10 mg/mL), fed Receives: Drug: TMC435 150 mg oral solution (10 mg/mL) |
| Treatment G | Experimental | Panel 3: single oral dose of 150 mg TMC435 150 mg capsule, fed Receives: Drug: TMC435 150 mg capsule |
| Treatment H | Experimental | Panel 3: single oral dose of 150 mg TMC435 capsule concept K, fed Receives: Drug: TMC435 150 mg capsule concept K |
| Treatment I | Experimental | Panel 3: single oral dose of 150 mg TMC435 capsule concept L, fed Receives: Drug: TMC435 150 mg capsule concept L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the bioavailability of oral solution and oral suspension formulation with the capsule formulation of TMC435 (fed state)
Comparing the rate and extent of absorption (bioavailability) of 2 different liquid formulations (oral suspension [150 mg ie, 20 mg/mL] and oral solution [150 mg ie, 10 mg/mL]) versus capsule formulation (150 mg) of TMC435, after a high-fat breakfast (fed state)
Measured: 4 days
Comparing the bioavailability of oral solution and oral suspension formulation of TMC435 in fed and fasted state
Comparing the rate and extent of absorption (bioavailability) of 2 different liquid formulations (oral suspension [150 mg ie, 20 mg/mL] and oral solution [150 mg ie, 10 mg/mL]) of TMC435 in fed state (high-fat breakfast) versus fasted state
Measured: 4 days
Comparing the bioavailability of concept K capsule and concept L capsule formulation with the capsule formulation of TMC435 (fed state)
Comparing the rate and extent of absorption (bioavailability) of 2 different capsule formulations (concept K capsule [150 mg] and concept L capsule [150 mg]) versus capsule formulation (150 mg) of TMC435 after a high-fat breakfast (fed state)
Measured: 4 days
Secondary outcomes (2)
Number of participants with adverse events
Adverse events, abnormal clinical laboratory findings, abnormalities assessed in vital signs examination, physical examination, ECG measurements were evaluated for safety and tolerability during the study
Measured: 18 days
Acceptability of taste assessed by taste questionnaires
Taste Questionnaires used to assess taste acceptability of oral suspension and solution of TMC435 under fasted conditions. Taste Questionnaire for adults: participant had to select appropriate choice (None, Weak, Moderate, Strong) for 3 different types of tastes "Sweetness, Bitterness, Flavour" and also select appropriate choice (Bad, Amost acceptable, Acceptable and Good) for the Overall taste. For pediatric participants: fill the visual analog scale by selecting appropriate choice (Dislike it very much, Dislike it a little, Not sure, Like it a little and Like it very much)
Measured: Day 1 of Treatment B and E
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen R&D Ireland
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen R&D Ireland Clinical Trial, Study director, Janssen R&D Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571570
- Sponsor's protocol ID
- CR100787
- Other IDs
- TMC435HPC1002
- Status last verified
- Jun 2013
- First submitted
- 23 Jan 2012
- Last updated
- 25 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Randomized, 3-Panel, 3-way Crossover Trial in Healthy Adult Subjects to Assess the Relative Bioavailability of TMC435 Following Administration of 2 Liquid Formulations or 2 Different Capsule Concept Formulations Compared ot the Phase III 150 mg Capsule, and to Assess the Effect of Food on the Bioavailability of TMC435 Following Administration of the Liquid Formulations.
- ClinicalTrials.gov ID
- NCT01571570
- Acronym / sponsor ID
- CR100787
- Conditions
- Healthy Volunteers
- Keywords
- Healthy volunteers, Food effect, Capsule, Formulations, Liquid formulation, Concept K, Concept L, Oral suspension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Janssen R&D IrelandIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 5 Apr 2012 (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 evaluate the relative bioavailability and the short-term safety and tolerability of TMC435 following administration of 3 single oral doses of 150 mg, given as different formulations in healthy adult participants. In addition, this study is to assess for the acceptability of the taste of both liquid formulations.
Detailed description
TMC435 is being investigated for the treatment of chronic hepatitis C infection. The current study is a Phase I, open-label (both participant and investigator know the name of the medication given at certain moment), randomized (study medication is assigned by chance) study designed to assess the relative bioavailability and food effect of 2 liquid formulations of TMC435, currently being developed for potential pediatric use, compared to the Phase III 150 mg capsule. Also new capsule concept formulations will be investigated in comparison with the Phase III 150 mg capsule. The study will be performed in healthy adult participants and is divided over 3 panels. Participants will be randomized within a panel. Each participant will receive 3 different treatments according to a classical 6-sequence, 3-period Williams design. In Panel 1 and Panel 2, a single oral dose of 150 mg TMC435 oral suspension respectively with other strength will be compared with the capsule used in Phase III. In Panel 3, two different capsule concept formulations will be compared with the capsule used in Phase III. In panels containing the liquids, formulations will be compared under fasted and fed conditions to investigate the food effect. In all treatments, the participants will receive medication on Day 1 of each treatment. There will be a washout period of at least 7 days between subsequent treatments. The main focus of the trial is the pharmacokinetic characteristics of all formulations (level-profile of TMC435 over time in the blood stream). This evaluation requires multiple blood samples from Day 1 till Day 4 in each treatment. Safety assessments (blood and urine tests, blood pressure, pulse, electrocardiogram, and physical examination) will follow a different schedule and will be evaluated from signing of the Informed Consent Form onwards until the last trial-related visit throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: TMC435 150 mg capsulePanel 1: single oral dose of 150 mg TMC435 150 mg capsule, fed |
| Treatment B | Experimental | Drug: TMC435 150 mg oral suspension (20 mg/mL)Panel 1: single oral dose of 150 mg TMC435 oral suspension (20 mg/mL), fasted |
| Treatment C | Experimental | Drug: TMC435 150 mg oral suspension (20 mg/mL)Panel 1: single oral dose of 150 mg TMC435 oral suspension (20 mg/mL), fed |
| Treatment D | Experimental | Drug: TMC435 150 mg capsulePanel 2: single oral dose of 150 mg TMC435 150 mg capsule, fed |
| Treatment E | Experimental | Drug: TMC435 150 mg oral solution (10 mg/mL)Panel 2: single oral dose of 150 mg TMC435 oral solution (10 mg/mL), fasted |
| Treatment F | Experimental | Drug: TMC435 150 mg oral solution (10 mg/mL)Panel 2: single oral dose of 150 mg TMC435 oral solution (10 mg/mL), fed |
| Treatment G | Experimental | Drug: TMC435 150 mg capsulePanel 3: single oral dose of 150 mg TMC435 150 mg capsule, fed |
| Treatment H | Experimental | Drug: TMC435 150 mg capsule concept KPanel 3: single oral dose of 150 mg TMC435 capsule concept K, fed |
| Treatment I | Experimental | Drug: TMC435 150 mg capsule concept LPanel 3: single oral dose of 150 mg TMC435 capsule concept L, fed |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteers should be healthy on the basis of physical examination, medical history, laboratory tests, 12-lead 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 screening.
- Women must be postmenopausal for at least 2 years and/or surgically sterile or not heterosexually active for duration of the trial.
Key exclusion criteria (6 listed)
- All participants with known allergies, hypersensitivity or intolerance to TMC435 or any of the excipients.
- Use of concomitant medication, including over the counter products, herbal medication and dietary supplements, except for paracetamol (acetaminophen) or ibuprofen.
- Any condition that, in the opinion of the investigator, would compromise the study or well-being of the participant 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 investigator's opinion would compromise participant's safety and/or compliance with the trial procedures.
- Participation in an investigational drug trial with TMC435.
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 150 mg capsuleAlso: TMC435single oral dose of 150 mg TMC435 150 mg capsule | Drug | Treatment A, Treatment D, Treatment G |
| TMC435 150 mg oral suspension (20 mg/mL)Also: TMC435single oral dose of 150 mg TMC435 oral suspension | Drug | Treatment B, Treatment C |
| TMC435 150 mg oral solution (10 mg/mL)Also: TMC435single oral dose of 150 mg TMC435 oral solution | Drug | Treatment E, Treatment F |
| TMC435 150 mg capsule concept KAlso: TMC435single oral dose of 150 mg TMC435 capsule concept K | Drug | Treatment H |
| TMC435 150 mg capsule concept LAlso: TMC435single oral dose of 150 mg TMC435 capsule concept L | Drug | Treatment I |
Primary outcome
Comparing the bioavailability of oral solution and oral suspension formulation with the capsule formulation of TMC435 (fed state)
Time frame: 4 days
Comparing the rate and extent of absorption (bioavailability) of 2 different liquid formulations (oral suspension [150 mg ie, 20 mg/mL] and oral solution [150 mg ie, 10 mg/mL]) versus capsule formulation (150 mg) of TMC435, after a high-fat breakfast (fed state)
Comparing the bioavailability of oral solution and oral suspension formulation of TMC435 in fed and fasted state
Time frame: 4 days
Comparing the rate and extent of absorption (bioavailability) of 2 different liquid formulations (oral suspension [150 mg ie, 20 mg/mL] and oral solution [150 mg ie, 10 mg/mL]) of TMC435 in fed state (high-fat breakfast) versus fasted state
Comparing the bioavailability of concept K capsule and concept L capsule formulation with the capsule formulation of TMC435 (fed state)
Time frame: 4 days
Comparing the rate and extent of absorption (bioavailability) of 2 different capsule formulations (concept K capsule [150 mg] and concept L capsule [150 mg]) versus capsule formulation (150 mg) of TMC435 after a high-fat breakfast (fed state)
2 secondary outcomes
Number of participants with adverse events
Time frame: 18 days
Acceptability of taste assessed by taste questionnaires
Time frame: Day 1 of Treatment B and E
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 25 Jun 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.
Janssen R&D Ireland Clinical Trial study director
Janssen R&D Ireland
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 TMC435 150 mg capsule, TMC435 150 mg oral suspension (20 mg/mL) and TMC435 150 mg oral solution (10 mg/mL) in people with Healthy Volunteers, run by Janssen R&D Ireland at 1 site in United Kingdom.
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 2 inclusion and 6 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 25 Jun 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 United Kingdom. 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. 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?
Comparing the bioavailability of oral solution and oral suspension formulation with the capsule formulation of TMC435 (fed state) (time frame: 4 days). The study lists 3 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 25 Jun 2013.