Results 161 to 170 of about 334,822 (292)

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

open access: yesClinical 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   +11 more
wiley   +1 more source

A Phase 1, Randomized, Open‐Label, Parallel Group Study to Evaluate the Relative Bioavailability and Safety of Subcutaneous Bepirovirsen when Delivered from a Vial or Prefilled Syringe Fitted with a Safety Syringe Device in Healthy Adult Participants

open access: yesClinical Pharmacology in Drug Development, EarlyView.
Abstract Bepirovirsen, an antisense oligonucleotide in development for the treatment of chronic hepatitis B virus (HBV) infection, is administered from glass vials as a subcutaneous (SC) injection by healthcare professionals (HCPs). A ready‐to‐use prefilled syringe (PFS) assembled with a safety syringe device (SSD) has been developed to make ...
Amir S. Youssef   +15 more
wiley   +1 more source

A Phase 1, Randomized, Placebo‐Controlled, Multiple‐Dose, Double‐Blind Study to Evaluate and Compare the Pharmacokinetics and Safety of Rimegepant in Healthy Adult Japanese and Caucasian Individuals

open access: yesClinical Pharmacology in Drug Development, EarlyView.
Abstract This Phase 1, randomized, placebo‐controlled, double‐blind study assessed the pharmacokinetic profile of rimegepant (25, 75, or 150 mg once daily for 14 days) in healthy Japanese and Caucasian adults. Exposures were modestly increased in Japanese participants compared with Caucasian participants following a single dose of rimegepant (Day 1 ...
Rajinder Bhardwaj   +6 more
wiley   +1 more source

An Update to the Clinical Pharmacogenetics Implementation Consortium (CPIC) SLCO1B1 Allele Functionality Table Leveraging Evidence from Participants of Predominantly Sub‐Saharan African Ancestry

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
The Clinical Pharmacogenetics Implementation Consortium (CPIC) has formally updated the SLCO1B1 allele functionality table based on new evidence. Notably, the alleles studied (SLCO1B1 *9, *31, *41) are enriched in the genomes of patients historically excluded from pharmacogenomics research.
Akinyemi Oni‐Orisan   +6 more
wiley   +1 more source

Quantitative Systems Toxicology Modeling with DILIsym to Support Phase 3 Dose Selection for Fezolinetant

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Fezolinetant is a first‐in‐class, selective, non‐hormonal, neurokinin 3 receptor antagonist that is approved for the treatment of moderate to severe vasomotor symptoms due to menopause. In a phase 2b clinical study (n = 352), nine study participants experienced elevations in serum transaminases exceeding three times the upper limit of normal.
Jace C. Nielsen   +11 more
wiley   +1 more source

Song: What Makes You Albumin (to the tune of “What Makes You Beautiful”*)

open access: yes
Biochemistry and Molecular Biology Education, EarlyView.
Seshadri Reddy Varikasuvu   +1 more
wiley   +1 more source

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