Hepatitis CPhase 1NCT01224197
TMC435 HPC1004 - Phase I Study Investigating the Pharmacokinetics of TMC435 in Healthy Chinese Volunteers
A Phase 1 study testing TMC435 in people with Hepatitis C, run by Tibotec Pharmaceuticals, Ireland at 1 site in Hong Kong.
Trial summary
The purpose of this study is to assess the pharmacokinetics, safety and tolerability of single and multiple oral doses of TMC435 in Chinese healthy volunteers. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body. 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
- 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 siteHong Kong
- Study dates
- Oct 2010to Jan 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
- Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram. Body Mass Index of 18.0 to 30.0 kg/m² and non-smoker or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months.
Who cannot join
- Infection with Hepatitis A, B or C virus
- infection with the Human Immunodeficiency Virus (HIV)
- Women who are pregnant or breastfeeding
- History of, or any current medical condition which could impact the safety of the participant in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I, Open Label, Randomized Study to Examine the Pharmacokinetics, Safety and Tolerability of Different Oral Doses of TMC435 After Single and Repeated Dosing in Healthy Chinese Subjects
The purpose of this study is to assess the pharmacokinetics, safety and tolerability of single and multiple oral doses of TMC435 in Chinese healthy volunteers. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.
Read the detailed description
TMC435 is being investigated for the treatment of chronic hepatitic C infection. The results of this study will provide dosing recommendations for the administration of TMC435 in Chinese HCV-infected patients. This 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 to investigate the pharmacokinetics, safety and tolerability of TMC435 after single and repeated intakes. Each participant will receive 2 treatments. First, participants will receive TMC435 as a single dose of 100 or 200 mg. Thereafter, in the multiple dose part, 100 or 200 mg TMC435 will be administered during 5 consecutuve days every morning. Both treatments will be administered with food. There will be a washout period of at least 72 hours between the 2 treatments. The main focus of the trial is the pharmacokinetic characteristics (level-profile of TMC435 over time in the blood stream). This evaluation requires multiple blood samples from Day 1 till Day 3 in the first session and from Day 1 till Day 11 in the second session. Safety assessments (blood and urine tests, blood pressure, pulse, electrocardiogram, and physical examination) will follow a different schedule and will be performed during each treatment period, up to 4 weeks after the last. Each volunteer participate in 2 treatments, i.e., single dose period and multiple dose period. In the single dose part, planned doses will be 100 or 200 mg TMC435. In the multiple dose part, TMC435 will be administered during 5 consecutive days every morning.
- Conditions
- Hepatitis C
- Being tested
- TMC435
- Keywords
- TMC435HPC1004, TMC435, HCV, Hepatitis C, Healthy Chinese volunteer
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMC435Drug
100 or 200 mg capsule, one single dose
TMC435Drug
100 or 200 mg capsule, once daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | TMC435 100 or 200 mg capsule one single dose Receives: Drug: TMC435 |
| 002 | Experimental | TMC435 100 or 200 mg capsule once daily for 5 days Receives: Drug: TMC435 |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma concentration of TMC435 after a single oral dose of 100 and 200 mg TMC435 in healthy Chinese volunteers in fed conditions
Measured: measured on Day 1, 2, 3
plasma concentration of TMC435 after a multiple oral dose of 100 and 200 mg TMC435 in healthy Chinese volunteers in fed conditions
Measured: measured on Day 4 until 11
Secondary outcomes (2)
Safety and tolerability of TMC435 after single oral dose of 100 and 200 mg in healthy Chinese volunteers
Measured: Day 1 until Day 3
Safety and tolerability of TMC435 after multiple oral dose of 100 and 200 mg q.d. for 5 days in healthy Chinese volunteers
Measured: Day 4 until Day 11 and 12 to 15 days and 38 to 43 days after last intake as safety follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJan 2011
- Study completionJan 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
- None (open label)
- Enrolment
- 32 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
- NCT01224197
- Sponsor's protocol ID
- CR017482
- Status last verified
- May 2014
- First submitted
- 18 Oct 2010
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open Label, Randomized Study to Examine the Pharmacokinetics, Safety and Tolerability of Different Oral Doses of TMC435 After Single and Repeated Dosing in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT01224197
- Acronym / sponsor ID
- CR017482
- Conditions
- Hepatitis C
- Keywords
- TMC435HPC1004, TMC435, HCV, Hepatitis C, Healthy Chinese volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Tibotec Pharmaceuticals, IrelandIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 19 Oct 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 pharmacokinetics, safety and tolerability of single and multiple oral doses of TMC435 in Chinese healthy volunteers. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.
Detailed description
TMC435 is being investigated for the treatment of chronic hepatitic C infection. The results of this study will provide dosing recommendations for the administration of TMC435 in Chinese HCV-infected patients. This 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 to investigate the pharmacokinetics, safety and tolerability of TMC435 after single and repeated intakes. Each participant will receive 2 treatments. First, participants will receive TMC435 as a single dose of 100 or 200 mg. Thereafter, in the multiple dose part, 100 or 200 mg TMC435 will be administered during 5 consecutuve days every morning. Both treatments will be administered with food. There will be a washout period of at least 72 hours between the 2 treatments. The main focus of the trial is the pharmacokinetic characteristics (level-profile of TMC435 over time in the blood stream). This evaluation requires multiple blood samples from Day 1 till Day 3 in the first session and from Day 1 till Day 11 in the second session. Safety assessments (blood and urine tests, blood pressure, pulse, electrocardiogram, and physical examination) will follow a different schedule and will be performed during each treatment period, up to 4 weeks after the last. Each volunteer participate in 2 treatments, i.e., single dose period and multiple dose period. In the single dose part, planned doses will be 100 or 200 mg TMC435. In the multiple dose part, TMC435 will be administered during 5 consecutive days every morning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: TMC435TMC435 100 or 200 mg capsule one single dose |
| 002 | Experimental | Drug: TMC435TMC435 100 or 200 mg capsule once daily for 5 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram. Body Mass Index of 18.0 to 30.0 kg/m² and non-smoker or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months.
Key exclusion criteria (4 listed)
- Infection with Hepatitis A, B or C virus
- infection with the Human Immunodeficiency Virus (HIV)
- Women who are pregnant or breastfeeding
- History of, or any current medical condition which could impact the safety of the participant in the study.
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 |
|---|---|---|
| TMC435100 or 200 mg capsule, one single dose | Drug | 001 |
| TMC435100 or 200 mg capsule, once daily for 5 days | Drug | 002 |
Primary outcome
plasma concentration of TMC435 after a single oral dose of 100 and 200 mg TMC435 in healthy Chinese volunteers in fed conditions
Time frame: measured on Day 1, 2, 3
plasma concentration of TMC435 after a multiple oral dose of 100 and 200 mg TMC435 in healthy Chinese volunteers in fed conditions
Time frame: measured on Day 4 until 11
2 secondary outcomes
Safety and tolerability of TMC435 after single oral dose of 100 and 200 mg in healthy Chinese volunteers
Time frame: Day 1 until Day 3
Safety and tolerability of TMC435 after multiple oral dose of 100 and 200 mg q.d. for 5 days in healthy Chinese volunteers
Time frame: Day 4 until Day 11 and 12 to 15 days and 38 to 43 days after last intake as safety follow up
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 8 May 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.
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 TMC435 in people with Hepatitis C, run by Tibotec Pharmaceuticals, Ireland at 1 site in Hong Kong.
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 1 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 8 May 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 Hong Kong. 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?
plasma concentration of TMC435 after a single oral dose of 100 and 200 mg TMC435 in healthy Chinese volunteers in fed conditions (time frame: measured on Day 1, 2, 3). 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 8 May 2014.