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Part 1 of this trial is a Phase Ib evaluation of the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) properties of Multiple Rising Dose (MRD) administration of BI 730357 to healthy volunteers for up to 28 days.
Part 2 is a Phase II evaluation of Proof of Clinical Concept (PoCC), based on the safety, tolerability and efficacy of multiple doses of BI 730357 administered to patients with moderate-to-severe plaque Psoriasis (PsO). This study will also serve the selection of doses for the further development of BI 730357.
- The primary objective of Part 2 is based on Week 12 co-primary endpoints of Psoriasis Area and Severity Index (PASI) 75 and Static Physician Global Assessment (sPGA) 0/1, and overall safety.
- Secondary objectives are to evaluate the safety of BI 730357 through 24 weeks of treatment, and the effects of dose escalation and longer treatment duration on efficacy
BI 730357, Placebo, Midazolam
Not yet recruiting
Published on BioPortfolio: 2017-09-13T00:23:22-0400
The primary objective of the Single-rising dose (SRD) part (trial part 1) is to investigate the safety and tolerability of BI 730357 in healthy subjects following oral administration of si...
CP-690,550 and midazolam are metabolized by similar enzymes in the liver. This study is designed to assess whether co-administration of CP-690,500 and midazolam will effect the metabolism ...
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The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam easier and more comfortable without affecting how the midazol...
The purpose of this study is to evaluate the effect of AC-080 on the pharmacokinetics of midazolam and 1-hydroxy midazolam and to evaluate the safety and tolerability of AC-080 when admini...
OBJECTIVE To determine the pharmacokinetic and pharmacodynamic effects of midazolam following IV and IM administration in sheep. ANIMALS 8 healthy adult rams. PROCEDURES Sheep were administered midazo...
Tenapanor (RDX5791, AZD1722) is an inhibitor of sodium/hydrogen exchanger isoform 3 in development for the treatment of constipation-predominant irritable bowel syndrome and the treatment of hyperphos...
It is the gold standard to use a placebo treatment as the control group in prospective randomized controlled trials (RCTs). Although placebo-controlled trials can reveal an effect of an active treatme...
The purpose of this study was to investigate the influence of breviscapine on the pharmacokinetics of concomitantly administered midazolam (MID) and its associations with and effects on genetic polymo...
This study evaluated whether deferiprone, an oral iron chelator, acts to prolong the QT interval. Fifty healthy volunteers received single doses of each of the following: therapeutic dose of deferipro...
Healthy People Programs are a set of health objectives to be used by governments, communities, professional organizations, and others to help develop programs to improve health. It builds on initiatives pursued over the past two decades beginning with the 1979 Surgeon General's Report, Healthy People, Healthy People 2000: National Health Promotion and Disease Prevention Objectives, and Healthy People 2010. These established national health objectives and served as the basis for the development of state and community plans. These are administered by the Office of Disease Prevention and Health Promotion (ODPHP). Similar programs are conducted by other national governments.
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Governmental guidelines and objectives pertaining to public food supply and nutrition including recommendations for healthy diet and changes in food habits to ensure healthy diet.
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
Surgical reinnervation of a denervated peripheral target using a healthy donor nerve and/or its proximal stump. The direct connection is usually made to a healthy postlesional distal portion of a non-functioning nerve or implanted directly into denervated muscle or insensitive skin. Nerve sprouts will grow from the transferred nerve into the denervated elements and establish contact between them and the neurons that formerly controlled another area.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Biocon Launches ALZUMAb™ - a ‘First in Class’ Novel Biologic Treatment for Psoriasis Patients in India • ALZUMAb™-World's first novel anti-CD6 antibody developed by Biocon to address a large unmet need for th...