Results 301 to 310 of about 488,286 (382)

A multipart phase 1 study of the safety, pharmacodynamics and pharmacokinetics of ALG‐055009, a novel thyroid hormone receptor beta (THR‐β) agonist for metabolic dysfunction‐associated steatohepatitis (MASH), in healthy participants

Clinical Pharmacology in Drug Development, EarlyView.
Abstract ALG–055009 is an oral thyroid hormone receptor beta (THR‐β) agonist being evaluated for treating metabolic dysfunction–associated steatohepatitis (MASH). This study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of ALG‐055009 and bioavailability/food effect.
Hakim Charfi, Benedetta Massetto, Megan Fitzgerald, Kha Le, Stanley Wang, Ifong Kan‐Eng, Meenakshi Venkatraman, Naqvi Mohammad, Lawrence Blatt, Tse‐I Lin, Sushmita M. Chanda, John Fry   +11 more
wiley   +1 more source

Investigating the effects of co-supplementation with alpha-linolenic acid and L-carnitine on inflammatory status, oxidative stress, clinical symptoms, mental health and quality of life in women with migraine: a protocol for a randomized, triple-blind, placebo-controlled trial. [PDF]

Trials
Golpour-Hamedani S, Bagherniy M, Khorvash F, Feizi A, Sharma M, Askari G.   +5 more
europepmc   +1 more source

The Pathway to Proof‐of‐Concept for BNC210, a Negative Allosteric Modulator of the Alpha‐7 Nicotinic Acetylcholine Receptor (nAChR), for Treatment of Psychiatric Disease

Clinical Pharmacology in Drug Development, EarlyView.
Abstract BNC210 is an investigational small molecule selective negative allosteric modulator of the alpha‐7 nicotinic acetylcholine receptor (α7 nAChR). It is an anxiolytic compound with a novel mechanism of action. In a series of Phase 1 clinical trials in healthy volunteers, psychometric test batteries showed that BNC210 did not cause attention ...
Paul Rolan, Elizabeth Doolin, Dharam Paul, Julia Crossman, Michael Odontiadis, Philippe Danjou, Mark Smith, Spyros Papapetropoulos   +7 more
wiley   +1 more source

Fool's-gold science : The ethical and scientific perils of testing most vaccines using placebo-controlled randomized trials. [PDF]

EMBO Rep
Caplan A, Pasadyn FL, Mamo N.
europepmc   +1 more source

The placebo and design research [PDF]

, 2012
Cash, Philip
core  

Assessment of Pharmacokinetic Drug Interaction of Asciminib with Atorvastatin in Healthy Participants

Clinical Pharmacology in Drug Development, EarlyView.
Abstract Asciminib is the first BCR::ABL1 inhibitor that Specifically Targets the ABL Myristoyl Pocket (STAMP) in patients with chronic myeloid leukemia. This phase 1, two‐treatment‐period, drug‐drug interaction study evaluated the effect of steady‐state asciminib on the pharmacokinetics of atorvastatin.
Matthias Hoch, Wendy Weis, Felix Huth, Seshulatha Jamalapuram, Michelle Quinlan, Amarnath Bandaru, Suleyman Eralp Bellibas, Asmae Mirkou, Shruti Kapoor, Shefali Kakar   +9 more
wiley   +1 more source

Silymarin-alpha lipoic acid and metabolic dysfunction-associated steatotic liver disease: Insights and methodological considerations. [PDF]

World J Hepatol
Martínez-Sánchez FD, Martínez-Vázquez SE, Gutiérrez-Monterrubio R, Muñoz-Martínez S, Garcia-Juarez I.   +4 more
europepmc   +1 more source

Evaluation of clinical cardiac safety of zilurgisertib, an activin receptor‐like kinase‐2 (ALK2) inhibitor, in healthy participants

Clinical Pharmacology in Drug Development, EarlyView.
Abstract The oral, small molecule inhibitor of activin receptor‐like kinase‐2, zilurgisertib (INCB000928), is under evaluation in fibrodysplasia ossificans progressiva. Cardiac safety was assessed using electrocardiogram (ECG) parameters and a plasma concentration‐heart rate‐corrected QT (C‐QTc) interval analysis of pooled data from single ascending ...
Yan‐ou Yang, Hong Yang, Xing Liu, Xiaohua Gong, Jay Getsy, Kevin Rockich   +5 more
wiley   +1 more source

What should constitute a control condition in psychedelic drug trials? [PDF]

Nat Ment Health
Colloca L, Fava M.
europepmc   +1 more source

Supplementing Single‐Arm Trials with External Control Arms—Evaluation of German Real‐World Data

Clinical Pharmacology &Therapeutics, EarlyView.
As single‐arm trials (SATs) are increasingly used in pharmaceutical research, the validity of such study designs needs to be critically assessed. We characterize the feasibility of supplementing SATs with real‐world data (RWD)‐derived external control arms by determining the proportion of SATs on breast cancer and amyotrophic lateral sclerosis (ALS ...
Martin Russek, Jonas Peltner, Britta Haenisch   +2 more
wiley   +1 more source