HealthyPhase 1NCT01891851
A Study of Drug-drug Interaction Between Ritonavir and TMC435350 in Healthy Volunteers
A Phase 1 study testing TMC435350 200 mg and Ritonavir 100 mg in people with Healthy, run by Tibotec Pharmaceuticals, Ireland at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the drug-drug interaction between steady-state concentrations of CYP3A4 or ritonavir and TMC435350 after its first and the last dose of the multiple dosing regimen and to explore the short term safety and tolerability of multiple doses of 200 mg of TMC435350 administered alone… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TMC435350 200 mg and Ritonavir 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2007to Jan 2008
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-smoking for at least 3 months prior to selection
- normal weight as defined by a Quetelet Index (Body Mass Index: weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included
- Informed Consent Form signed voluntarily, prior to the first trial related activity
- normal 12-lead electrocardiogram (ECG) at screening
- healthy on the basis of a medical evaluation and results fo the laboratory tests at screening.
Who cannot join
- past history of heart arrhythmias,
- female, except if postmenopausal for more than two years, or post-hysterectomy or post-tubal ligation (without reversal operation)
- history or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use
- hepatitis A, B and C infections or human immunodeficiency virus type 1 (HIV-1) or HIV-2 infections at study screening
- donation of blood or plasma in the 60 days preceding the first intake of trial medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I, Open-label Trial in Healthy Subjects to Evaluate the Drug-drug Interaction Between Ritonavir at Steady-state and TMC435350, a Viral Protease Inhibitor Against Hepatitis C Virus, After the First and the Last Dose of a Multiple Dosing Regimen
The purpose of this study is to evaluate the drug-drug interaction between steady-state concentrations of CYP3A4 or ritonavir and TMC435350 after its first and the last dose of the multiple dosing regimen and to explore the short term safety and tolerability of multiple doses of 200 mg of TMC435350 administered alone and in combination with 100 mg of ritonavir.
Read the detailed description
This trial is a Phase I, open label trial (meaning that both the research physician and study participants will know which medication is being administered during the trial) in 12 healthy volunteers (referred to as participants) to investigate the effect of ritonavir, a marketed product used in several HIV medications, on the plasma levels of TMC435350, a new investigational drug in process of development for the treatment of hepatitis-C virus (HCV) infections. TMC435350 is a protease inhibitor (PI), a class of drugs that selectively inhibit the replication of the virus thereby inhibiting the progression of HCV infection. Plasma levels of TMC435350 are circulating levels of TMC435350 in the blood that are important for the antiviral activity of TMC435350. Ritonavir has the ability to increase the circulating levels of other compounds administered on the same day as Ritonavir. The trial will consist of 2 sequential sessions (Session 1 and Session 2) and all participants enrolled in the study will enter each session. In Session 1, participants will take TMC435350 200mg orally (by mouth) once daily for 7 days. There will be a waiting period of at least 7 days to allow any drug left in the body after the last treatment in Session 1 to be eliminated before the start of Session 2 (referred to as a "washout period"). In Session 2, participants will take ritonavir 100 mg orally twice daily on Days 1 to 15 and TMC435350 200mg once daily on Days 6 to 12. All study drugs in both treatment sessions will be taken under fed conditions (i. e., participants will eat a standard breakfast within approximately 30 minutes before they take study drug). Full pharmacokinetic profiles of TMC435350 (to investigate how the drug moves through the body, including the absorption, distribution, metabolism and elimination of the drug) will be determined from blood samples obtained on Days 1 and 7 of Session 1 and on Days 6 and 12 of Session 2. Safety and tolerability will be recorded continuously. The total duration of treatment in the study for each participant will be approximately 30 days (includes 7 days of treatment in Session 1, 16 days of treatment in Session 2, and a washout period of at least 7 days between treatment sessions).
- Conditions
- Healthy
- Being tested
- TMC435350 200 mg, Ritonavir 100 mg
- Keywords
- Healthy, Hepatitis C, TMC435350, Ritonavir, Pharmacokinetics
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMC435350 200 mgDrug
Each patient will receive 200 mg (2 capsules) once daily orally from Day 1 to Day 7 in Session 1 and from Day 6 to Day 12 in Session 2
Ritonavir 100 mgDrug
Each patient will receive 100 mg (1 capsule) of ritonavir twice daily orally from Day 1 until Day 15 of Session 2
| Study group | Role | What they receive |
|---|---|---|
| TMC435350 / Ritonavir | Experimental | TMC435350 2 capsules of 100-mg twice daily / Ritonavir one 100-mg capsule twice daily Receives: Drug: TMC435350 200 mg; Drug: Ritonavir 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of TMC435350
In Session 1, the plasma concentration of TMC435350 is measured in the absence of ritonavir.
Measured: Days 1 and 7 of Session 1
Plasma concentration of TMC435350
In Session 2, the plasma concentration of TMC435350 is measured in the presence of ritonavir.
Measured: Days 6 and 16 of Session 2
Secondary outcomes (1)
Number of patients reporting adverse events (AEs) as a measure of safety and tolerability
Adverse events will be reported from the time the participant signs the Informed Consent Form (ICF) up to the completion of the last trial-related visit which will be approximately 86 days (includes up to 21 days during the screening period, 7 days during treatment session 1, at least 7 days between treatment sessions, 16 days during treatment session 2, and for up to 35 days after the last dose in treatment session 2). The incidence of AEs under Session 1 will be compared with the incidence of AEs under session 2
Measured: Up to approximately 86 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startOct 2007
- Primary completionJan 2008
- Study completionJan 2008
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tibotec Pharmaceuticals, Ireland
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tibotec Pharmaceuticals Limited, Ireland Clinical Trial, Study director, Tibotec Pharmaceuticals, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891851
- Sponsor's protocol ID
- CR014773
- Other IDs
- TMC435350-TiDP16-C104
- Status last verified
- Oct 2013
- First submitted
- 28 Jun 2013
- Last updated
- 14 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open-label Trial in Healthy Subjects to Evaluate the Drug-drug Interaction Between Ritonavir at Steady-state and TMC435350, a Viral Protease Inhibitor Against Hepatitis C Virus, After the First and the Last Dose of a Multiple Dosing Regimen
- ClinicalTrials.gov ID
- NCT01891851
- Acronym / sponsor ID
- CR014773
- Conditions
- Healthy
- Keywords
- Healthy, Hepatitis C, TMC435350, Ritonavir, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Tibotec Pharmaceuticals, IrelandIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 3 Jul 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 drug-drug interaction between steady-state concentrations of CYP3A4 or ritonavir and TMC435350 after its first and the last dose of the multiple dosing regimen and to explore the short term safety and tolerability of multiple doses of 200 mg of TMC435350 administered alone and in combination with 100 mg of ritonavir.
Detailed description
This trial is a Phase I, open label trial (meaning that both the research physician and study participants will know which medication is being administered during the trial) in 12 healthy volunteers (referred to as participants) to investigate the effect of ritonavir, a marketed product used in several HIV medications, on the plasma levels of TMC435350, a new investigational drug in process of development for the treatment of hepatitis-C virus (HCV) infections. TMC435350 is a protease inhibitor (PI), a class of drugs that selectively inhibit the replication of the virus thereby inhibiting the progression of HCV infection. Plasma levels of TMC435350 are circulating levels of TMC435350 in the blood that are important for the antiviral activity of TMC435350. Ritonavir has the ability to increase the circulating levels of other compounds administered on the same day as Ritonavir. The trial will consist of 2 sequential sessions (Session 1 and Session 2) and all participants enrolled in the study will enter each session. In Session 1, participants will take TMC435350 200mg orally (by mouth) once daily for 7 days. There will be a waiting period of at least 7 days to allow any drug left in the body after the last treatment in Session 1 to be eliminated before the start of Session 2 (referred to as a "washout period"). In Session 2, participants will take ritonavir 100 mg orally twice daily on Days 1 to 15 and TMC435350 200mg once daily on Days 6 to 12. All study drugs in both treatment sessions will be taken under fed conditions (i. e., participants will eat a standard breakfast within approximately 30 minutes before they take study drug). Full pharmacokinetic profiles of TMC435350 (to investigate how the drug moves through the body, including the absorption, distribution, metabolism and elimination of the drug) will be determined from blood samples obtained on Days 1 and 7 of Session 1 and on Days 6 and 12 of Session 2. Safety and tolerability will be recorded continuously. The total duration of treatment in the study for each participant will be approximately 30 days (includes 7 days of treatment in Session 1, 16 days of treatment in Session 2, and a washout period of at least 7 days between treatment sessions).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMC435350 / Ritonavir | Experimental | Drug: TMC435350 200 mg, Drug: Ritonavir 100 mgTMC435350 2 capsules of 100-mg twice daily / Ritonavir one 100-mg capsule twice daily |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- non-smoking for at least 3 months prior to selection
Key exclusion criteria (5 listed)
- past history of heart arrhythmias,
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 |
|---|---|---|
| TMC435350 200 mgEach patient will receive 200 mg (2 capsules) once daily orally from Day 1 to Day 7 in Session 1 and from Day 6 to Day 12 in Session 2 | Drug | TMC435350 / Ritonavir |
| Ritonavir 100 mgEach patient will receive 100 mg (1 capsule) of ritonavir twice daily orally from Day 1 until Day 15 of Session 2 | Drug | TMC435350 / Ritonavir |
Primary outcome
Plasma concentration of TMC435350
Time frame: Days 1 and 7 of Session 1
In Session 1, the plasma concentration of TMC435350 is measured in the absence of ritonavir.
Plasma concentration of TMC435350
Time frame: Days 6 and 16 of Session 2
In Session 2, the plasma concentration of TMC435350 is measured in the presence of ritonavir.
1 secondary outcome
Number of patients reporting adverse events (AEs) as a measure of safety and tolerability
Time frame: Up to approximately 86 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 14 Oct 2013.
- Phase I, open-label trial in healthy subjects to evaluate the drug-drug interaction between ritonavir at steady-state and TMC435350, a viral protease inhibitor against hepatitis C virus, after the first and the last dose of a multiple dosing regimenLink 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.
Tibotec Pharmaceuticals Limited, Ireland Clinical Trial study director
Tibotec Pharmaceuticals, 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 TMC435350 200 mg and Ritonavir 100 mg in people with Healthy, run by Tibotec Pharmaceuticals, Ireland at 1 site in Belgium.
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 5 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 14 Oct 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 Belgium. 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 TMC435350 (time frame: Days 1 and 7 of Session 1). 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 14 Oct 2013.