Healthy VolunteerPhase 1NCT01288677
TMC649128HPC1001 - First In-human Trial to Examine Safety, Tolerability, and Pharmacokinetics (How the Drug is Absorbed Into the Bloodstream) of Increasing Single Oral Doses of TMC649128 in Healthy Volunteers
A Phase 1 study testing TMC649128 in people with Healthy Volunteer, run by Tibotec Pharmaceuticals, Ireland.
Trial summary
The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of single oral doses of TMC649128 in 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
- Healthy Volunteer
- What is being tested?
- TMC649128
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Jan 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
- 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 for at least 3 months prior to selection
- Women must be postmenopausal for at least 2 years and/or be surgically sterile.
Who cannot join
- Infection with Hepatitis A, B or C virus
- infection with the Human Immunodeficiency Virus (HIV)
- History of, or any current medical condition which could impact the safety of the participant in the study
- A positive urine drug test at screening
- History of any drug allergy or clinically relevant skin disease
- Participation in an investigational drug trial or received an investigational vaccine within 30 days prior to intake.
About this study
Official title: Phase I, First In-human, Double-blind, Randomized, Placebo-controlled Trial to Examine the Safety, Tolerability, and Blood and Plasma Pharmacokinetics of Increasing Single Oral Doses of TMC649128
The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of single oral doses of TMC649128 in 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
TMC649128 will be investigated for the treatment of chronic hepatitis C infection. This is a Phase I, first in humans (no clinical studies have been performed to date), double-blind (neither the participant nor investigator knows whether they receive active or placebo), randomized (study medication is assigned by chance), placebo-controlled study to examine the safety, tolerability, and blood and plasma pharmacokinetics of increasing single oral doses of TMC649128. The single dose escalation will consist of 6 sessions (Sessions I to IV) in 6 panels (Panels 1 to 6) of 9 healthy adult volunteers each. The dose of TMC649128 will be consecutively escalated. In each session, 6 participants will receive TMC649128 and 3 participants will receive placebo, all with standard meals. Each session will have a staggered approach, ie, the first 4 participants will be dosed, followed by at least a 72-hour safety review and if no acute effects are observed, the remaining 5 participants will be dosed. The main focus of the trial is the determination of safety and tolerability of TMC649128 after single oral doses in fed conditions in healthy volunteers, but also the determination of the pharmacokinetic characteristics (level-profile of TMC649128 over time in the blood stream and urine). This evaluation requires multiple blood samples from Day 1 to Day 4. Safety assessments (blood and urine tests, blood pressure, pulse, electrocardiogram, and physical examination) will follow a different schedule and will be performed during each session, up to 4 weeks after the last administration. Safety and tolerability evaluations will be recorded at regular intervals throughout the trial. The single dose escalation will consist of 6 sessions in 6 panels of 9 healthy adult volunteers each. The dose of TMC649128 will be consecutively escalated.
- Conditions
- Healthy Volunteer
- Being tested
- TMC649128
- Keywords
- Healthy volunteer, TMC649128HPC1001, TMC649128, HCV, Hepatitis C, healthy volunteers, Phase I trial
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMC649128Drug
Escalated doses
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | TMC649128 Escalated doses Receives: Drug: TMC649128 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of volunteers with adverse events, if any
Measured: Up to Day 4
Laboratory evaluations of blood and urine samples
Measured: Up to Day 4
Vital signs evaluations
Measured: Up to Day 4
Electrocardiogram evaluations
Measured: Up to Day 4
Secondary outcomes (1)
Plasma concentration of TMC649128 after a single oral dose of TMC649128 in healthy volunteers in fed conditions
Measured: Measured on Day 1 to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionJun 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 Healthy VolunteerStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 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
- NCT01288677
- Sponsor's protocol ID
- CR017272
- Other IDs
- TMC649128HPC1001
- Status last verified
- Mar 2013
- First submitted
- 13 Jan 2011
- Last updated
- 20 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, First In-human, Double-blind, Randomized, Placebo-controlled Trial to Examine the Safety, Tolerability, and Blood and Plasma Pharmacokinetics of Increasing Single Oral Doses of TMC649128
- ClinicalTrials.gov ID
- NCT01288677
- Acronym / sponsor ID
- CR017272
- Conditions
- Healthy Volunteer
- Keywords
- Healthy volunteer, TMC649128HPC1001, TMC649128, HCV, Hepatitis C, healthy volunteers, Phase I trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Tibotec Pharmaceuticals, IrelandIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 2 Feb 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 assess the pharmacokinetics, safety, and tolerability of single oral doses of TMC649128 in healthy volunteers. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body, and eliminated from the body.
Detailed description
TMC649128 will be investigated for the treatment of chronic hepatitis C infection. This is a Phase I, first in humans (no clinical studies have been performed to date), double-blind (neither the participant nor investigator knows whether they receive active or placebo), randomized (study medication is assigned by chance), placebo-controlled study to examine the safety, tolerability, and blood and plasma pharmacokinetics of increasing single oral doses of TMC649128. The single dose escalation will consist of 6 sessions (Sessions I to IV) in 6 panels (Panels 1 to 6) of 9 healthy adult volunteers each. The dose of TMC649128 will be consecutively escalated. In each session, 6 participants will receive TMC649128 and 3 participants will receive placebo, all with standard meals. Each session will have a staggered approach, ie, the first 4 participants will be dosed, followed by at least a 72-hour safety review and if no acute effects are observed, the remaining 5 participants will be dosed. The main focus of the trial is the determination of safety and tolerability of TMC649128 after single oral doses in fed conditions in healthy volunteers, but also the determination of the pharmacokinetic characteristics (level-profile of TMC649128 over time in the blood stream and urine). This evaluation requires multiple blood samples from Day 1 to Day 4. Safety assessments (blood and urine tests, blood pressure, pulse, electrocardiogram, and physical examination) will follow a different schedule and will be performed during each session, up to 4 weeks after the last administration. Safety and tolerability evaluations will be recorded at regular intervals throughout the trial. The single dose escalation will consist of 6 sessions in 6 panels of 9 healthy adult volunteers each. The dose of TMC649128 will be consecutively escalated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: TMC649128TMC649128 Escalated doses |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 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 for at least 3 months prior to selection
- Women must be postmenopausal for at least 2 years and/or be surgically sterile.
Key exclusion criteria (6 listed)
- Infection with Hepatitis A, B or C virus
- infection with the Human Immunodeficiency Virus (HIV)
- History of, or any current medical condition which could impact the safety of the participant in the study
- A positive urine drug test at screening
- History of any drug allergy or clinically relevant skin disease
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 |
|---|---|---|
| TMC649128Escalated doses | Drug | 001 |
Primary outcome
Number of volunteers with adverse events, if any
Time frame: Up to Day 4
Laboratory evaluations of blood and urine samples
Time frame: Up to Day 4
Vital signs evaluations
Time frame: Up to Day 4
Electrocardiogram evaluations
Time frame: Up to Day 4
1 secondary outcome
Plasma concentration of TMC649128 after a single oral dose of TMC649128 in healthy volunteers in fed conditions
Time frame: Measured on Day 1 to Day 4
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 20 Mar 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.
Tibotec Pharmaceuticals Clinical Trial study director
Tibotec Pharmaceutical Limited
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TMC649128 in people with Healthy Volunteer, 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 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 20 Mar 2013. 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?
Number of volunteers with adverse events, if any (time frame: Up to Day 4). The study lists 4 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 20 Mar 2013.