10 results
1)To assess the preliminary pharmacokinetics of [14C]-Org 201745, [14C] Org 244378 and [14C] Org 245021 when administered as a sub-therapeutic dose by the oral route to healthy post-menopausal female volunteers.2) To evaluate the safety and…
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…
The objective of this study is to evaluate the immune respons against the H1N1 strain following vaccination with the first dose of trivalent inactivated influenza virus vaccine (Fluarix) in subjects previously vaccinated with 2 doses of H1N1…
The primary objective of the study is to demonstrate a reduction in intravascular hemolysis by REGN3918 over 26 weeks of treatment in patientswith active PNH who are treatment-naive to complement inhibitor therapy or have not recently received…
The primary objective of the study is to evaluate the long-term safety, tolerability, and effect on intravascular hemolysis (ie, proportion ofpatients achieving lactate dehydrogenase (LDH) * 1.5× upper limit of normal (ULN) over 26 weeks) of…
The purposes of this trial are:• To find out the side effects (unexpected or unwanted reactions from taking a drug) when JNJ-64264681 and JNJ-67856633 are given in combination. • To find out how and at what dose(s) the combination of JNJ-64264681…
PrimaryTo determine the pharmacologically optimal dose of ALRN-6924 to induce transient cell cycle arrest in human bone marrow and other tissues.SecondaryTo characterize relative to ALRN-6924 administration the time to onset, the magnitude, and the…
PrimaryTo evaluate the safety and tolerability of single and multiple doses of TBAJ-587 in healthy participants.SecondaryTo determine the pharmacokinetics (PK) of single and multiple doses of TBAJ-587 and metabolites M2, M3 and M12. To compare the…
Primary- Part 1: To identify recommended Phase 2 doses and schedules (RP2Ds) for each combination.- Part 2: To characterize the safety of each RP2D for each combinationSecondary- To characterize the pharmacokinetics and pharmacodynamics of each…
To investigate the safety and tolerability of GSK2556286 after single ascending and repeat oral doses in healthy adult participants.To determine the pharmacokinetics of single and repeat oral doses of GSK2556286 in healthy participants.To assess the…