19 results
The primary objective is to determine the maximum tolerated dose (MTD) of docetaxel (as ModraDoc001) that can safely be administered to patients with cancer in a bi-daily weekly schedule.
The primary objective of this study is to evaluate the safety and antiviral efficacy, defined as the percentage of subjects with sustained virologic response 12 weeks post-dosing (SVR12; HCV RNA < LLOQ 12 weeks after the last dose of study…
The main objective of this study is to investigate of the drug EMD 525797 is better then no treatment with subjects with metastasized asymptomatic or mild symptomatic mCRPC. The efficacy and safety of the drug EMD 525797 is evaluated.Primary…
The purpose of the study is to investigate how quickly Danoprevir is absorbed and the extent of absorption and elimination from the body (this is called pharmacokinetics and bioavailability) when it is administered intravenously (IV) or orally alone…
Primary objective* To assess the non-inferiority of darunavir/r + raltegravir compared to darunavir/r + tenofovir/emtricitabine as first-line treatment strategies in HIV-1 infected, antiretroviral naïve adults over at least 96 weeks (i.e. to assess…
The primary objective of this study is to quantitatively determine the pharmacokinetics (absorption, distribution, metabolism and excretion) of docetaxel (as ModraDoc003 10mg tablets) after administration of a single dose of oral docetaxel in…
Primary Objective: To assess the effect of multiple oral doses of atazanavir 300 mg + ritonavir 100 mg once daily on the PK of BMS-790052 at steady state in healthy subjects.Secondary Objective(s): To assess the safety of multiple oral doses of BMS-…
Primary: To determine the influence of posaconazole on unboosted fosamprenavir pharmacokinetics, and vice versa, in healthy volunteersSecondary: To determine the safety of combined use of fosamprenavir with posaconazole in healthy vol-unteers
Part 1A:Primary objective is to evaluate the safety and tolerability of ascending single doses of TDT 077 in healthy older male and female subjects. Secondary objective is to evaluate the systemic exposure (PK) of ascending single doses of TDT 077…
Primary Objectives:• To assess the effects of VOR 200 mg BID on the steady-state PK of ATV administered as ATV/RTV300/100 mg QD in healthy subjects• To assess the effects of ATV/RTV 300/100 mg QD on the steady-state PK of VOR 200 mg BID inhealthy…
Primary objective: To evaluate the influence of fosamprenavir/ritonavir on single-dose pharmacokinetics of olanzapine in healthy volunteersSecondary objective: To evaluate the safety of fosamprenavir/ritonavir combined with single-dose olanzapine in…
The primary objectives are:* to determine the effect of steady-state concentrations of TMC114 coadministered with a lowdose of ritonavir on the steady-state pharmacokinetics of ddI,* to determine the effect of steady-state concentrations of ddI on…
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The primary objective of this study is to evaluate the effect of multiple doses of azithromycin, clarithromycin and ritonavir on the pharmacokinetics, safety and tolerability of a single oral 150 mg dose of ivacaftor in healthy controls and in…
To determine the effect of a high-fat meal on the exposure to docetaxel given as ModraDoc006 tablets in combination with ritonavir in patients with cancer.
Primary objective:To compare the effect of multiple dose atazanavir/cobicistat on the multiple dose phar-macokinetics of daclatasvir with the effect of atazanavir/ritonavir on the multiple dose of daclatasvir by intra-subject comparison in healthy…
The primary aim of this trial is to determine the recommended safe dose and schedule of ModraDoc006/r in castration-resistant prostate cancer (CRPC) patients. The first 5 CRPC patients in this study showed a different pharmacokinetic profile, as…
Primary: 1. Effect of the highly potent CYP3A4 inhibitor ritonavir on the pharmacokinetics (PK) of erlotinib, measured as AUC0-24h, AUCmean, Cmax and CminSecondary objective 1. Safety of the CYP3A4 moderator ritonavir in combination with erlotinib,…
To determine the maximum tolerated dose (MTD) of ModraDoc006/r (as ModraDoc006 10 mg tablets in combination with one tablet of 100 mg ritonavir) that can safely be administered in a bi-daily weekly schedule in combination with high-dose intensity…