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Issue Information
(Source: Clinical Pharmacology in Drug Development)
Source: Clinical Pharmacology in Drug Development - April 3, 2023 Category: Drugs & Pharmacology Tags: Issue Information Source Type: research

Single ‐ and Multiple‐dose Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP1128, a Novel Peroxisome Proliferator‐activated Receptor δ Modulator, in Healthy Participants
In conclusion, single and multiple intravenous doses of ASP1128 were generally well tolerated, with dose-dependent pharmacokinetics and target gene engagement in healthy participants. (Source: Clinical Pharmacology in Drug Development)
Source: Clinical Pharmacology in Drug Development - March 27, 2023 Category: Drugs & Pharmacology Authors: Yuta Taniuchi, J. W. Olivier Till, Tomasz Wojtkowski, Junko Toyoshima, Akira Koibuchi, Briana Sargent, David Han Tags: Original Article Source Type: research

Dosing Recommendation Based on the Effects of Different Meal Types on Pexidartinib Pharmacokinetics in Healthy Subjects: Implementation of Model ‐informed Drug Development Strategy
This report provides the outcome of the implementation of the model-informed drug development strategy to recommend and justify a low-fat meal dosing regimen for pexidartin ib that has the potential to improve patient compliance while maintaining drug exposure. (Source: Clinical Pharmacology in Drug Development)
Source: Clinical Pharmacology in Drug Development - March 21, 2023 Category: Drugs & Pharmacology Authors: Hamim Zahir, Ophelia Yin, Ching Hsu, Andrew J. Wagner, Jason Jiang, Xiaoning Wang, Jon Greenberg, Dale E. Shuster, Tarundeep Kakkar, Frank LaCreta Tags: Original Article Source Type: research

Safety, Tolerability, and Pharmacokinetics of IMU ‐935, a Novel Inverse Agonist of Retinoic Acid Receptor–Related Orphan Nuclear Receptor γt: Results From a Double‐Blind, Placebo‐Controlled, First‐in‐Human Phase 1 Study
In conclusion, IMU-935 was safe with no dose-limiting toxicities and had a PK profile that supports once-daily dosing. (Source: Clinical Pharmacology in Drug Development)
Source: Clinical Pharmacology in Drug Development - March 21, 2023 Category: Drugs & Pharmacology Authors: Thomas M. Polasek, Indika Leelasena, Irina Betscheider, Marija Marolt, Hella Kohlhof, Daniel Vitt, Frank Fliegert, Andreas R. Muehler Tags: Original Article Source Type: research

Effect of Food on the Pharmacokinetics and Pharmacodynamics of a Novel Dual Delayed ‐Release Formulation of Esomeprazole in Healthy Subjects
In conclusion, although the systemic exposure of esomeprazole decreased when DR esomeprazole was administered in the fed state compared to that in the fasted state, the degree of gast ric acid secretion inhibition was not clinically different, regardless of food intake. (Source: Clinical Pharmacology in Drug Development)
Source: Clinical Pharmacology in Drug Development - March 17, 2023 Category: Drugs & Pharmacology Authors: Sejung Hwang, Sung Hee Hong, Jina Jung, Jae ‐Yong Chung, In‐Jin Jang, SeungHwan Lee Tags: Original Article Source Type: research

Exposure –response Modeling From the CLARITY Trial of Pimavanserin for Adjunctive Treatment of Major Depressive Disorder
AbstractIn the 10-week, phase 2 CLARITY study of patients with major depressive disorder, adjunctive therapy to antidepressants with pimavanserin 34  mg once daily statistically significantly improved the Hamilton Depression Rating Scale (HAMD-17) total score (primary endpoint) and Sheehan Disability Scale (SDS) score (secondary endpoint) versus placebo. This analysis characterized the exposure–response (E–R) relationships of pimavanserin i n this CLARITY patient population. Exposure measures were estimated for each patient based on population-pharmacokinetic empirical Bayesian estimates. E–R models were developed t...
Source: Clinical Pharmacology in Drug Development - March 7, 2023 Category: Drugs & Pharmacology Authors: Mona Darwish, Bryan Dirks, Julie Passarell, David Jaworowicz, Sebastien Bihorel, Becky Howell, Joel Owen, Daryl DeKarske, Srdjan Stankovic Tags: Original Article Source Type: research

Comparative Bioavailability of a Novel Solution and a Tablet Formulation of Levothyroxine
AbstractLevothyroxine (LT4)  is the standard of care for treating hypothyroidism. Despite the established efficacy of LT4, 50% of treated patients fail to achieve normal thyrotropin levels. Oral formulations of LT4 that bypass the gastric phase of dissolution may offset some of the therapeutic shortcomings observed with table ts. An oral solution of LT4 can be administered to patients who are unable to swallow tablets; allows flexibility to individualize dosing; and may mitigate interference with LT4 absorption caused by food, coffee, increased gastric pH from atrophic gastritis, and malabsorption from bariatric surgery. ...
Source: Clinical Pharmacology in Drug Development - March 6, 2023 Category: Drugs & Pharmacology Authors: Sunil Vandse, Yannis Psarrakis, Kris Washington, Michelle A. Baron Tags: Original Article Source Type: research