HealthyPhase 1NCT02071355
A Study to Examine the Pharmacokinetics, Safety and Tolerability of Multiple Oral Doses of TMC435 in Healthy Chinese Participants
A Phase 1 study testing TMC435 100 mg and TMC435 150 mg in people with Healthy, run by Janssen Research & Development, LLC at 1 site in China.
Trial summary
The purpose of this study is to determine the pharmacokinetics (what the body does to a medication) of TMC435 after multiple oral doses of 100 and 150 mg TMC435 once daily for 7 days in healthy Chinese 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
- What is being tested?
- TMC435 100 mg and TMC435 150 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to Jun 2014
- 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 Chinese participants on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram, and clinical laboratory tests performed at screening
- Must be non-smoking for at least 3 months prior to screening as confirmed by a urine cotinine test
- A Body Mass Index (BMI) of 18.0 to 30.0 kg/square meter, extremes included (BMI is calculated as BMI = body weight in kg divided by the square of height in meters)
- Participants must agree to use one of the contraception methods defined in the protocol
Who cannot join
- Positive human immunodeficiency virus - type 1 and 2; syphilis; hepatitis A, B or C infection at screening
- History or presence of liver or renal clearance insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
- History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic medicines use
- Any history of significant skin disease such as but not limited to, rash or eruptions, allergies, dermatitis, eczema (inflammation of the skin), psoriasis (an inflammatory skin disease), or urticarial (a raised and itchy rash that appears on the skin)
- Female participants who are breastfeeding at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I, Open Label Study to Examine the Pharmacokinetics, Safety and Tolerability of TMC435 Following Multiple Oral Doses of 100 and 150 mg q.d. in Healthy Chinese Subjects
The purpose of this study is to determine the pharmacokinetics (what the body does to a medication) of TMC435 after multiple oral doses of 100 and 150 mg TMC435 once daily for 7 days in healthy Chinese participants.
Read the detailed description
This is an open-label (both [participants and investigator] know what treatment participants will receive) and randomized (study medication is assigned by chance) study. The study consists of 3 phases: a screening phase (within 21 days prior to administration of study medication), a treatment phase (from day -1 [1 days before the administration of study medication] to Day 10 including pharmacokinetics sample collection), and follow-up phase (up to 16 days after the last dose of study medication or after dropout [other than withdrawal of consent]). Approximately 32 healthy participants will be equally divided into 2 groups (Group 1 and Group 2) to receive TMC435 for 7 days. Safety will be evaluated by the assessment of adverse events, clinical laboratory tests, vital signs, and physical examination which will be monitored at various timepoints throughout the study. The total duration of study participation for each participant will be approximately 47 days.
- Conditions
- Healthy
- Being tested
- TMC435 100 mg, TMC435 150 mg
- Keywords
- Healthy, Chinese participants, TMC435, Multiple oral doses, Pharmacokinetics, Safety, Tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMC435 100 mgDrug
Participants will receive TMC435 100 mg capsule once daily from Day 1 to Day 7 after food.
TMC435 150 mgDrug
Participants will receive TMC435 150 mg capsule once daily from Day 1 to Day 7 after food.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants will receive 100 mg TMC435 once daily for 7 days. Receives: Drug: TMC435 100 mg |
| Group 2 | Experimental | Participants will receive 150 mg TMC435 once daily for 7 days. Receives: Drug: TMC435 150 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predose plasma concentration of TMC435
Measured: Predose on Days 1, 5, 6, and 7
Minimum plasma concentration of TMC435
Measured: Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours)
Maximum plasma concentration of TMC435
Measured: Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours)
Time to reach the maximum plasma concentration of TMC435
Measured: Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours)
Area under the plasma concentration-time curve of TMC435 from time of administration up to 24 hours after dosing
Measured: Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours)
Area under the plasma concentration-time curve of TMC435 from time of administration up to the last time point with a measurable concentration after dosing
Measured: Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours)
Average steady-state plasma concentration of TMC435
Measured: Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours)
Fluctuation index of TMC435
Fluctuation index, ie, percentage fluctuation: variation between maximum (Cmax) and minimum (Cmin) plasma concentration at steady-state, calculated as: 100 x ([Cmax-Cmin]/Css,av). Css,av is an average steady-state plasma concentration.
Measured: Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours)
Secondary outcomes (1)
Number of participants with adverse events
Measured: Up to 47 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2014
- Study completionJun 2014
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.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071355
- Sponsor's protocol ID
- CR018526
- Other IDs
- TMC435HPC1001
- Status last verified
- Sep 2014
- First submitted
- 24 Feb 2014
- Last updated
- 30 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open Label Study to Examine the Pharmacokinetics, Safety and Tolerability of TMC435 Following Multiple Oral Doses of 100 and 150 mg q.d. in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT02071355
- Acronym / sponsor ID
- CR018526
- Conditions
- Healthy
- Keywords
- Healthy, Chinese participants, TMC435, Multiple oral doses, Pharmacokinetics, Safety, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 25 Feb 2014 (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 determine the pharmacokinetics (what the body does to a medication) of TMC435 after multiple oral doses of 100 and 150 mg TMC435 once daily for 7 days in healthy Chinese participants.
Detailed description
This is an open-label (both [participants and investigator] know what treatment participants will receive) and randomized (study medication is assigned by chance) study. The study consists of 3 phases: a screening phase (within 21 days prior to administration of study medication), a treatment phase (from day -1 [1 days before the administration of study medication] to Day 10 including pharmacokinetics sample collection), and follow-up phase (up to 16 days after the last dose of study medication or after dropout [other than withdrawal of consent]). Approximately 32 healthy participants will be equally divided into 2 groups (Group 1 and Group 2) to receive TMC435 for 7 days. Safety will be evaluated by the assessment of adverse events, clinical laboratory tests, vital signs, and physical examination which will be monitored at various timepoints throughout the study. The total duration of study participation for each participant will be approximately 47 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: TMC435 100 mgParticipants will receive 100 mg TMC435 once daily for 7 days. |
| Group 2 | Experimental | Drug: TMC435 150 mgParticipants will receive 150 mg TMC435 once daily for 7 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Chinese participants on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram, and clinical laboratory tests performed at screening
- Must be non-smoking for at least 3 months prior to screening as confirmed by a urine cotinine test
- A Body Mass Index (BMI) of 18.0 to 30.0 kg/square meter, extremes included (BMI is calculated as BMI = body weight in kg divided by the square of height in meters)
- Participants must agree to use one of the contraception methods defined in the protocol
Key exclusion criteria (5 listed)
- Positive human immunodeficiency virus - type 1 and 2; syphilis; hepatitis A, B or C infection at screening
- History or presence of liver or renal clearance insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
- History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic medicines use
- Any history of significant skin disease such as but not limited to, rash or eruptions, allergies, dermatitis, eczema (inflammation of the skin), psoriasis (an inflammatory skin disease), or urticarial (a raised and itchy rash that appears on the skin)
- Female participants who are breastfeeding at screening
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 100 mgParticipants will receive TMC435 100 mg capsule once daily from Day 1 to Day 7 after food. | Drug | Group 1 |
| TMC435 150 mgParticipants will receive TMC435 150 mg capsule once daily from Day 1 to Day 7 after food. | Drug | Group 2 |
Primary outcome
Predose plasma concentration of TMC435
Time frame: Predose on Days 1, 5, 6, and 7
Minimum plasma concentration of TMC435
Time frame: Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours)
Maximum plasma concentration of TMC435
Time frame: Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours)
Time to reach the maximum plasma concentration of TMC435
Time frame: Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours)
Area under the plasma concentration-time curve of TMC435 from time of administration up to 24 hours after dosing
Time frame: Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours)
Area under the plasma concentration-time curve of TMC435 from time of administration up to the last time point with a measurable concentration after dosing
Time frame: Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours)
Average steady-state plasma concentration of TMC435
Time frame: Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours)
Fluctuation index of TMC435
Time frame: Postdose on Day 7 (1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours)
Fluctuation index, ie, percentage fluctuation: variation between maximum (Cmax) and minimum (Cmin) plasma concentration at steady-state, calculated as: 100 x ([Cmax-Cmin]/Css,av). Css,av is an average steady-state plasma concentration.
1 secondary outcome
Number of participants with adverse events
Time frame: Up to 47 days
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 30 Sep 2014.
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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 Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
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 100 mg and TMC435 150 mg in people with Healthy, run by Janssen Research & Development, LLC at 1 site in China.
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 4 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 30 Sep 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 China. 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?
Predose plasma concentration of TMC435 (time frame: Predose on Days 1, 5, 6, and 7). 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 30 Sep 2014.