4 results
2.1.1 Primary Objective1.Evaluate the LDL-C-lowering effects of ERN/LRPT/SIM 2 g/20 mg compared to ERN/LRPT 2 g coadministered with simvastatin 20 mg.Hypothesis: ERN/LRPT/SIM 2 g/20 mg is equivalent to ERN/LRPT 2 g coadministered with simvastatin 20…
Single dose:The objectives of Part 1 (single dose escalation part) are to examine the safety, tolerability and pharmacokinetics (i.e., the circulating levels of TMC558445 in your blood over time) of increasing single oral doses of TMC558445, with…
To investigate the safety, tolerability and behavior in the body (absorption and excretion) of oral intake of TMC589337 and TMC589354 after ascending single intakes. In addition, the safety, tolerability and behavior in the body after multipe dose…
To assess the efficacy and safety of 2 dose levels of NTRA-2112 on intestinal malabsorption in preterm infants as compared to placebo.The sub-study aims to determine whether NTRA-2112 in own mother's milk, donor human milk or preterm formula…