A Phase 1 interventional study of TMC435350 200 mg and Ritonavir 100 mg in Healthy, sponsored by Tibotec Pharmaceuticals, Ireland. Completed at 1 site in Belgium. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-10-14.
Sponsored by Tibotec Pharmaceuticals, Ireland (part of Johnson & Johnson) · Phase 1, Interventional, and Treatment
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.
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).
2,356 studies on the registry are indexed under Hepatitis C; 101 are open to participants now.
This study's enrollment of 12 is below the median of 79 across 1,660 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →Tibotec Pharmaceuticals, Ireland is the lead sponsor of 77 studies on the registry; none are open to participants now.
First submitted after Tibotec Pharmaceuticals, Ireland became part of Johnson & Johnson.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
non-smoking for at least 3 months prior to selection
Exclusion Criteria:
past history of heart arrhythmias,
TMC435350 2 capsules of 100-mg twice daily / Ritonavir one 100-mg capsule twice daily
Drug: TMC435350 200 mg · Drug: Ritonavir 100 mg
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
Each patient will receive 100 mg (1 capsule) of ritonavir twice daily orally from Day 1 until Day 15 of Session 2
Plasma concentration of TMC435350
In Session 1, the plasma concentration of TMC435350 is measured in the absence of ritonavir.
Time frame: 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.
Time frame: Days 6 and 16 of Session 2
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
Time frame: Up to approximately 86 days
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Simeprevir · Ritonavir
Tibotec Pharmaceuticals, Ireland →