View clinical trials related to Healthy Subjects.
Filter by:This was a single-center study using induced blood stage malaria infection to characterize the activity of ACT-451840 against early Plasmodium falciparum blood stage infection
This thorough QT (TQT) study will take place in healthy subjects administered single doses of study drug. It will be a randomized, double-blind, placebo and active-controlled, 4-treatment crossover study. Subjects will be randomized in an equal ratio to one of 12 possible treatment sequences. Each treatment sequence will comprise all 4 treatments.
Oxidative stress has been implicated to play a pathogenic role in many disease processes, especially in age-related disorders such as age-related macular degeneration. It has been hypothesized that antioxidative agents such as vitamins and minerals, which are capable of scavenging free radicals, may reduce oxidative stress and may, in turn, be beneficial for patients with age-related disorders. Based on this hypothesis several different combinations of vitamins have been introduced, all targeting at reducing oxidative stress. However, the in-vivo effect of the antioxidative properties of a certain drug or vitamin combination is hard to investigate. In the current study, we propose to investigate the effect of Retaron®, a combination of carotoinoids, omega-3-fatty acids, a herbal extract of Aronia, vitamins and trace elements, in a systemic in-vivo inflammation model. In the present study, the infusion of LPS, which is a cell wall component of gram-negative bacteria and a major mediator in the pathogenesis of septic shock, will be used as a standardized experimental model of systemic inflammation in humans. Given that inflammation is associated with enhanced oxidative stress and widespread endothelial dysfunction, the LPS model is well suitable for determination of the antioxidative effects of Retaron®. As a main outcome parameter the vascular reactivity of retinal vessels to systemic hyperoxia (induced by breathing 100% oxygen) will be tested in presence or absence of the antioxidant combination.
This study consists of two parts. Part 1 evaluates the effect of renal impairment on the PK and PD of a single dose of ASP8232. In addition, the safety and tolerability will be assessed. Part 2 evaluates the PK, PD, and safety and tolerability of multiple doses of ASP8232 compared with placebo in Type 2 Diabetes Mellitus (T2DM) subjects with Chronic Kidney Disease (CKD).
This study is primarily designed to bridge the pharmacokinetics (PK) and safety data for E2609 between Japanese subjects and non-Japanese (ie, white) subjects. To bridge these PK characteristics, the proposed study includes a cohort of white subjects treated for comparison with the cohort of Japanese subjects treated at the same dose. This comparison serves as a key PK bridge in assessing ethnic factors that may contribute to differences in plasma concentrations. Pharmacokinetic assessments in the proposed study will include confirmation of dose proportionality in Japanese subjects. This study will also evaluate safety and tolerability in Japanese subjects.
To compare PK, safety and tolerability of LBAL developed by LG Life Sciences Ltd. With those of Humira®.
The purpose of this study is to assess the safety and pharmacokinetics of APD356 in healthy Japanese adult subjects. Regarding cohorts 1 to 3, this study is a single center, placebo-controlled, randomized,double-blind study. Regarding cohort 4, this study is a single center, randomized, open-label study that consists of two sequential two-way crossover studies. The study consists of 4 cohorts. In cohort 1, subjects will be randomized to 10 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug. In cohort 2, subjects will be randomized to 20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug. In cohort 3, subjects will be randomized to XR-20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug on Day 1 and multiple doses of study drug on Day 8-14 once daily before breakfast. In cohort 4, subjects will be randomized to Sequence A (8 subjects) or Sequence B (8 subjects) to receive study drug in the sequence shown below. Sequence A: 10 mg tablet, 2 doses (12 hours apart) => XR-20 mg orange tablet, single dose => XR-20 mg orange tablet, q. d., multiple doses (fasted) => XR-20 mg orange tablet, q. d., multiple dose (fed) Sequence B: XR-20 mg orange tablet, single dose => 10 mg tablet, 2 doses (12 hours apart) => XR-20 mg orange tablet, q. d., multiple dose (fed) => XR-20 mg orange tablet, q. d., multiple doses (fasted)
The purpose of this study to explore the effect of multiple oral doses of itraconazole on the pharmacokinetics of a single oral dose of ASP1707 in healthy female subjects. This study will also evaluate the safety and tolerability of a single oral dose of ASP1707 alone and in combination with itraconazole.
A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single 1.5mL dose of Brodalumab (140mg/mL) vs. two doses (1.0mL + 0.5mL) of Brodalumab (140mg/mL)
The purpose of this study is to evaluate the effect of solifenacin and mirabegron on the concentrations of tamsulosin HCl after combined dosing. This study will also evaluate the safety and tolerability of the combined administration of solifenacin, mirabegron and tamsulosin HCl.