Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of Youkenafil Hydrochloride, a Phosphodiesterase Type 5 Inhibitor, in Healthy Chinese Male Volunteers
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DOI: 10.1002/cpdd.1108
Abstract: Youkenafil hydrochloride is a novel selective phosphodiesterase type 5 inhibitor for the treatment of erectile dysfunction. Its safety, tolerability, and pharmacokinetics were evaluated in healthy Chinese male volunteers. In addition, this study explored the effect… read more here.
Keywords: tolerability; type inhibitor; phosphodiesterase type; tolerability pharmacokinetics ... See more keywords
Randomized Trial of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2831781 in Healthy Japanese and White Participants
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DOI: 10.1002/cpdd.1165
Abstract: This study investigated ethnic differences in the safety, tolerability, pharmacokinetics, and pharmacodynamics of GSK2831781, an anti–lymphocyte activation gene 3 (LAG3) monoclonal antibody, in healthy participants, and determined local tolerability and bioavailability following subcutaneous (SC) administration.… read more here.
Keywords: tolerability pharmacokinetics; pharmacokinetics pharmacodynamics; white participants; japanese white ... See more keywords
Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacological Effect of Orally Administered CORT125134: An Adaptive, Double‐Blind, Randomized, Placebo‐Controlled Phase 1 Clinical Study
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DOI: 10.1002/cpdd.389
Abstract: CORT125134 is an orally active, high‐affinity, selective antagonist of the glucocorticoid receptor that is being developed for indications that may benefit from the modulation of cortisol activity. This first‐in‐human study was conducted to evaluate the… read more here.
Keywords: safety tolerability; pharmacological effect; study; tolerability pharmacokinetics ... See more keywords
Randomized Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Topical Daprodustat in Healthy Volunteers and in Patients With Diabetic Foot Ulcers
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DOI: 10.1002/cpdd.654
Abstract: Daprodustat, a small‐molecule inhibitor of prolyl hydroxylases, prevents breakdown of hypoxia‐inducible factor (HIF), leading to increased transcription of HIF‐responsive genes. This randomized, placebo‐controlled study evaluated the safety, tolerability, and pharmacokinetics of a topical formulation of… read more here.
Keywords: daprodustat; safety tolerability; safety; healthy volunteers ... See more keywords
Safety, Tolerability, and Pharmacokinetics of PF‐06823859, an Anti–Interferon β Monoclonal Antibody: A Randomized, Phase I, Single‐ and Multiple‐Ascending‐Dose Study
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DOI: 10.1002/cpdd.887
Abstract: This double‐blind, randomized, placebo‐controlled, dose‐ascending, first‐in‐human study (NCT02766621) assessed the safety, tolerability, and pharmacokinetics (PK) of PF‐06823859, an anti–interferon β monoclonal antibody. Healthy subjects were randomized to single ascending doses (SADs) of intravenous PF‐06823859 30,… read more here.
Keywords: placebo; safety tolerability; tolerability pharmacokinetics; interferon ... See more keywords
Safety, Tolerability and Pharmacokinetics of Yimitasvir Phosphate Capsule, a Novel Oral Hepatitis C Virus NS5A Inhibitor, in Healthy Chinese Volunteers
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DOI: 10.1007/s40261-019-00791-8
Abstract: Background and ObjectivesYimitasvir is a novel oral hepatitis C virus non-structural protein 5A (NS5A) inhibitor. The aims of this first-in-human study were to evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of… read more here.
Keywords: oral hepatitis; ns5a inhibitor; safety tolerability; novel oral ... See more keywords
First-in-Man Safety, Tolerability, and Pharmacokinetics of a Novel and Highly Selective Inhibitor of Matrix Metalloproteinase-12, FP-025: Results from Two Randomized Studies in Healthy Subjects
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DOI: 10.1007/s40261-020-00981-9
Abstract: Background and Objectives Matrix metalloproteinases (MMPs) are proteases with different biological and pathological activities, and many have been linked to several diseases. Targeting individual MMPs may offer a safer therapeutic potential for several diseases. We… read more here.
Keywords: highly selective; safety tolerability; capsule; study ... See more keywords
Safety, tolerability, pharmacokinetics and pharmacodynamics of the anti‐CD38 cytolytic antibody TAK‐079 in healthy subjects
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DOI: 10.1111/bcp.14241
Abstract: This investigation characterised tolerability, pharmacokinetics and pharmacodynamics of the anti‐CD38 antibody TAK‐079. read more here.
Keywords: antibody tak; pharmacodynamics anti; tak 079; tolerability pharmacokinetics ... See more keywords
A phase 1 study to evaluate the safety, tolerability and pharmacokinetics of TAK‐041 in healthy participants and patients with stable schizophrenia
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DOI: 10.1111/bcp.15305
Abstract: TAK‐041 (NBI‐1065846), an orally available, investigational, small molecule agonist of GPR139, an orphan G‐protein‐coupled receptor, has shown promise in preclinical studies for the treatment of symptoms associated with schizophrenia. Here, we report the results from… read more here.
Keywords: study evaluate; evaluate safety; phase study; tolerability pharmacokinetics ... See more keywords
Safety, Tolerability, and Pharmacokinetics of the Novel Antiviral Agent Ensitrelvir Fumaric Acid, a SARS-CoV-2 3CL Protease Inhibitor, in Healthy Adults
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DOI: 10.1128/aac.00632-22
Abstract: Ensitrelvir is a novel selective inhibitor of the 3C-like protease of SARS-CoV-2, which is essential for viral replication. This phase 1 study of ensitrelvir assessed its safety, tolerability, and pharmacokinetics of single (part 1, n = 50)… read more here.
Keywords: inhibitor; ensitrelvir; tolerability pharmacokinetics; safety tolerability ... See more keywords
Safety, Tolerability, and Pharmacokinetics of Telacebec (Q203), a New Antituberculosis Agent, in Healthy Subjects
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DOI: 10.1128/aac.01436-21
Abstract: Telacebec (Q203) is a potent drug candidate under clinical development for the treatment of drug-naïve and drug-resistant tuberculosis. The first-in-human randomized, placebo-controlled, double-blind, dose-escalation Phase 1A trial (Q203-TB-PI-US001) was conducted to evaluate the safety, tolerability,… read more here.
Keywords: safety tolerability; drug; tolerability pharmacokinetics; cohort ... See more keywords