HealthyPhase 4NCT01804244
A Single-Dose Pharmacokinetics and Safety Study of TMC278 in Healthy Adult Japanese Participants
A Phase 4 study testing TMC278 in people with Healthy, run by Janssen Pharmaceutical K.K. at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics and safety of TMC278 after a single oral dose of TMC278 25 mg tablet (27.5 mg as the hydrochloride salt) under fed conditions in healthy Japanese adult male participants. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TMC278
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2013to Mar 2013
- Phase
- Phase 4
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Japanese healthy men
- body mass index (BMI) between 18.5 and 25.0 kg/m², inclusive and a body weight of not less than 50 kg
Who cannot join
- History of or current medical illness considered by the investigator to be clinically significant and should exclude the participant or that could interfere with the interpretation of the study results
- Laboratory abnormality of grade 2 or greater (defined by the World Health Organization Adult Toxicity Table) or clinically significant abnormal values as assessed by the investigators
- Clinically significant abnormal physical examination and vital signs at screening as assessed by the investigators
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), within 14 days before the dose of TMC278 25 mg tablet
- History of clinically significant drug or food allergies, especially known hypersensitivity and/or known allergy to TMC278 or any of the excipients of the formulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-dose Study to Investigate the Pharmacokinetics and Safety of TMC278 After Oral Administration of TMC278 25 mg Tablet Under Fed Condition in Healthy Japanese Adult Male Subjects
The purpose of this study is to evaluate the pharmacokinetics and safety of TMC278 after a single oral dose of TMC278 25 mg tablet (27.5 mg as the hydrochloride salt) under fed conditions in healthy Japanese adult male participants.
Read the detailed description
This is a single center, open-label (all study staff and participants will know the identity of the treatment assigned), single dose study in healthy Japanese adult male participants. The study consists of 3 phases: a screening phase up to 26 days; an inpatient phase from Day -2 to Day 8; and a follow-up assessment phase that occurs on Day 15 (± 2 days) or at the time of the participant's early withdrawal from the study. Participants who meet the selection criteria will be admitted to the investigational institute on two days before the dose (Day -2). All enrolled participants will receive orally (by mouth) a single dose of one TMC278 25 mg tablet on Day 1 within 10 minutes after completion of the standardized breakfast. Enrolled participants will remain in the investigational institute for the entire duration of the inpatient phase. Participants will be discharged on Day 8 after the completion of all required assessments. Blood samples for determination of plasma concentrations of TMC278 will be collected over a period of 168 hours (7 days). The maximum study duration for each participant is 45 days, including the screening phase, in-patient period, and follow-up visit.
- Conditions
- Healthy
- Being tested
- TMC278
- Keywords
- Healthy, Pharmacokinetics, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMC278Drug
1 25-mg tablet [27.5 mg as the hydrochloride salt) taken orally (by mouth) within 10 minutes after completion of a standardized breakfast on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| TMC278 | Experimental | All participants will receive a single-dose of TMC278 (1 25-mg tablet [27.5 mg as the hydrochloride salt]) after an overnight fast (going without food) of at least 10 hours before eating a standard breakfast. Study drug will be taken within 10 minutes after completion of a standardized breakfast. Receives: Drug: TMC278 |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma TMC278 concentrations
Blood samples will be taken at 16 timepoints: Predose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120, and 168 hours postdose.
Measured: Baseline (predose) up to 168 hours postdose
Secondary outcomes (1)
The number of participants who experience adverse events
As a measure of safety and tolerability
Measured: Up to 17 days following study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutical K.K., Japan Clinical Trial, Study director, Janssen Pharmaceutical K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804244
- Sponsor's protocol ID
- CR101181
- Other IDs
- TMC278IFD4005
- Status last verified
- Mar 2014
- First submitted
- 1 Mar 2013
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose Study to Investigate the Pharmacokinetics and Safety of TMC278 After Oral Administration of TMC278 25 mg Tablet Under Fed Condition in Healthy Japanese Adult Male Subjects
- ClinicalTrials.gov ID
- NCT01804244
- Acronym / sponsor ID
- CR101181
- Conditions
- Healthy
- Keywords
- Healthy, Pharmacokinetics, Japanese
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 5 Mar 2013 (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 pharmacokinetics and safety of TMC278 after a single oral dose of TMC278 25 mg tablet (27.5 mg as the hydrochloride salt) under fed conditions in healthy Japanese adult male participants.
Detailed description
This is a single center, open-label (all study staff and participants will know the identity of the treatment assigned), single dose study in healthy Japanese adult male participants. The study consists of 3 phases: a screening phase up to 26 days; an inpatient phase from Day -2 to Day 8; and a follow-up assessment phase that occurs on Day 15 (± 2 days) or at the time of the participant's early withdrawal from the study. Participants who meet the selection criteria will be admitted to the investigational institute on two days before the dose (Day -2). All enrolled participants will receive orally (by mouth) a single dose of one TMC278 25 mg tablet on Day 1 within 10 minutes after completion of the standardized breakfast. Enrolled participants will remain in the investigational institute for the entire duration of the inpatient phase. Participants will be discharged on Day 8 after the completion of all required assessments. Blood samples for determination of plasma concentrations of TMC278 will be collected over a period of 168 hours (7 days). The maximum study duration for each participant is 45 days, including the screening phase, in-patient period, and follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMC278 | Experimental | Drug: TMC278All participants will receive a single-dose of TMC278 (1 25-mg tablet [27.5 mg as the hydrochloride salt]) after an overnight fast (going without food) of at least 10 hours before eating a standard breakfast. Study drug will be taken within 10 minutes after completion of a standardized breakfast. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Japanese healthy men
- body mass index (BMI) between 18.5 and 25.0 kg/m², inclusive and a body weight of not less than 50 kg
Key exclusion criteria (5 listed)
- History of or current medical illness considered by the investigator to be clinically significant and should exclude the participant or that could interfere with the interpretation of the study results
- Laboratory abnormality of grade 2 or greater (defined by the World Health Organization Adult Toxicity Table) or clinically significant abnormal values as assessed by the investigators
- Clinically significant abnormal physical examination and vital signs at screening as assessed by the investigators
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), within 14 days before the dose of TMC278 25 mg tablet
- History of clinically significant drug or food allergies, especially known hypersensitivity and/or known allergy to TMC278 or any of the excipients of the formulation
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 |
|---|---|---|
| TMC2781 25-mg tablet [27.5 mg as the hydrochloride salt) taken orally (by mouth) within 10 minutes after completion of a standardized breakfast on Day 1. | Drug | TMC278 |
Primary outcome
plasma TMC278 concentrations
Time frame: Baseline (predose) up to 168 hours postdose
Blood samples will be taken at 16 timepoints: Predose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120, and 168 hours postdose.
1 secondary outcome
The number of participants who experience adverse events
Time frame: Up to 17 days following study drug administration
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 19 Mar 2014.
- An Open-label, Single-dose Study to Investigate the Pharmacokinetics and Safety of TMC278 after Oral Administration of TMC278 25 mg Tablet under Fed Condition in Healthy Japanese Adult Male SubjectsLink provided by the sponsor.
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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 Pharmaceutical K.K., Japan Clinical Trial study director
Janssen Pharmaceutical K.K.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TMC278 in people with Healthy, run by Janssen Pharmaceutical K.K. at 1 site in Japan.
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 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 19 Mar 2014. 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 Japan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
plasma TMC278 concentrations (time frame: Baseline (predose) up to 168 hours postdose). 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 19 Mar 2014.