81 results
In this study, we will investigate how quickly and to what extent etrumadenant is absorbed, transported, and eliminated from the body. For this study, etrumadenant is radioactively labelled with carbon 14 (14C). In this way, etrumadenant can be…
Primary:1. To characterize the safety and tolerability of multiple oral doses of K-196 alone and in combination with naproxen/omeprazole in healthy subjects.Secondary:1. To assess the effects of K-196 compared to placebo on the proportion of…
Primary objective:To assess the bioequivalence of single dose STB after administration of standardized breakfast followed by a whole tablet (reference) and a crushed and suspended tablet (intervention I).To assess the bioequivalence of single dose…
The primary objective is to evaluate the long-term safety and tolerability of BRV at individualized doses up to a maximum of 200mg/day in focal epilepsy subjects.The second objective is to evaluate the maintenance of efficacy of BRV over time.
The objectives of this clinical trial are as follows:1. To assess the safety and tolerability of OLT1177 Capsule after oral administration in subjects with an acute gout flare2. To assess the clinical activity of various doses of OLT1177 Capsule in…
The primary objective is to compare, in healthy subjects, the injection site experience of a single dose of 0.25 mg semaglutide sc, given as the DV3396 product to that of the PDS290 product.
In this study, we will investigate what the effect of the new compound emvododstat is on how quickly and to what extent 2 approved medications (dextromethorphan in Part 1 and rosuvastatin in Part 2) are absorbed, transported, and eliminated from the…
The primary objective is to assess the clinical efficacy of dapansutrile versus placebo in subjects presenting with moderate COVID-19 respiratory symptoms and evidence of early cytokine release syndrome.Secondary objectives are to assess:* Complete…
The primary objective of this study is to determine whether SAR439859 in combination with palbociclib improves progression free survival (PFS) compared to letrozole in combination with palbociclib in patients with ER +, HER2-advanced breast cancer…
To evaluate the efficacy of danicopan as compared to placebo as add-on therapy to a C5 inhibitor at 12 weeks.
The objective of the first two cohorts of this study is to explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06372865 after a single dose across a wide exposure range up to the maximum tolerated dose or the maximum…
The primary objective of this study is:• To evaluate the non-inferiority of switching to a TAF Containing STR relative to maintaining TDF Containing Regimens in Virologically Suppressed HIV-1 positive subjects as determined by having HIV 1 RNA * 50…
To investigate effect of tizanidine ER 12 mg on simulated driving performance, cognitive and psychomotor functions compared with placebo, tizanidine IR 8 mg (two 4 mg doses given 6.5 hours apart) and active-control in healthy subjects
The primary objective of this study is:• To evaluate the efficacy of a single-tablet regimen (STR) containingelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) versus a STRcontaining elvitegravir/cobicistat/emtricitabine/…
To establish the MTD and/or recommended phase II dose of the coadministration of LDE225 and INC424 in patients with MF, who have not previously received therapy with a JAK inhibitor
Primary:To demonstrate the efficacy of LMTM as assessed by the change from Baseline on:* Addenbrooke*s Cognitive Examination Revised (ACE-R)* Symptomatic effect as reflected by the Functional Activities Questionnaire (FAQ)* Disease-modifying effect…
The purpose of the study is to investigate how quickly and to what extent BIM23B065 is distributed, metabolized (broken down) and excreted from the body, and what the main route of excretion from the body is (urine or feces); this is called…
Primary objective: to assess the inhibition of allergic responses of a single dose of subcutaneously (SC) administered REGN1908-1909 as measured by total nasal symptom score (TNSS), visual analog scale (VAS) nasal symptoms score, and peak nasal…
The primary objective of the study is to evaluate the safety and tolerability of a range of single IV and SC doses of BG00010 in healthy volunteers, and a range of multiple SC doses of BG00010 in subjects with painful lumbar radiculopathy.Secondary…
1. To demonstrate the clinical efficacy of leuco-methylthioninium bis(hydromethanesulfonate) (also known as LMTM,TRx0237) in mild Alzheimer*s disease as assessed by change from baseline on:• Alzheimer*s Disease Assessment Scale - Cognitive Subscale…