Safety, Tolerability, and Feasibility of Young Plasma Infusion in the Plasma for Alzheimer Symptom Amelioration Study: A Randomized Clinical Trial
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DOI: 10.1001/jamaneurol.2018.3288
Abstract: Importance Young mouse plasma restores memory in aged mice, but, to our knowledge, the effects are unknown in patients with Alzheimer disease (AD). Objective To assess the safety, tolerability, and feasibility of infusions of young… read more here.
Keywords: plasma; safety tolerability; safety; study ... See more keywords
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
Phase 1 Study to Investigate the Safety, Tolerability, and Pharmacokinetics of EPI‐589 in Healthy Participants
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DOI: 10.1002/cpdd.1146
Abstract: EPI‐589 attenuates oxidative stress due to the radical scavenging activity of the reduced form and affects mitochondrial energy metabolism as a substrate of quinone‐oxidoreductases. Given the effects of EPI‐589 on oxidative stress and mitochondrial dysfunction,… read more here.
Keywords: healthy participants; epi 589; twice daily; phase study ... 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
Pharmacokinetic, Safety, and Tolerability Evaluations of Gepotidacin (GSK2140944) in Healthy Japanese Participants
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DOI: 10.1002/cpdd.1192
Abstract: Gepotidacin is a novel, bactericidal, first‐in‐class triazaacenaphthylene antibiotic in late‐phase development for uncomplicated urinary tract infection and uncomplicated urogenital gonorrhea. Two clinical studies were conducted to assess the pharmacokinetics (PK) and interethnic comparisons of oral… read more here.
Keywords: healthy japanese; tolerability; pharmacokinetic safety; tolerability evaluations ... See more keywords
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
Sign Up to like & getrecommendations! Published in 2023 at "Clinical Pharmacology in Drug Development"
DOI: 10.1002/cpdd.1243
Abstract: Retinoic acid receptor–related orphan nuclear receptor (ROR)γt regulates the transcription of interleukin‐17 and other cytokines implicated in inflammatory and autoimmune diseases. We assessed the safety, tolerability, and pharmacokinetics (PK) of IMU‐935, an inverse agonist of… read more here.
Keywords: receptor; imu 935; safety tolerability; placebo ... See more keywords
Pharmacokinetics, Safety, and Tolerability of Brivaracetam in Healthy Elderly Participants.
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DOI: 10.1002/cpdd.1264
Abstract: The pharmacokinetics, metabolism, safety, and tolerability of the antiseizure medication brivaracetam (BRV) were characterized in 16 healthy elderly participants (8 men/8 women) aged 65-78 years who received a single 200-mg oral dose of BRV on day… read more here.
Keywords: brivaracetam; healthy elderly; safety tolerability; elderly participants ... See more keywords
Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Recombinant Neorudin, a New Anticoagulant Drug in Patients With Acute Coronary Syndrome
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DOI: 10.1002/cpdd.1478
Abstract: This study evaluated the safety, tolerability, pharmacodynamics, and pharmacokinetics of recombinant neorudin (EPR‐hirudin [EH]) in patients with acute coronary syndrome (ACS), providing a basis for further therapeutic research. This open‐label, single‐center, nonrandomized, nonblinded, and noncontrolled… read more here.
Keywords: drug; pharmacodynamics pharmacokinetics; safety tolerability; tolerability pharmacodynamics ... See more keywords
The Safety, Tolerability, and Pharmacokinetics of Active Ingredients From Hydroxysafflor Yellow A in Healthy Chinese Volunteers
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DOI: 10.1002/cpdd.1487
Abstract: Hydroxysafflor yellow A (HSYA), an active ingredient extracted from Carthami flos, shows potential for treating ischemic stroke. This phase 1 study assessed the safety, tolerability, and pharmacokinetic (PK) properties of HSYA in healthy Chinese volunteers… read more here.
Keywords: healthy chinese; hydroxysafflor yellow; study; safety tolerability ... See more keywords
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Bexicaserin in Healthy Participants: A First-in-Human Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Escalation Phase 1 Study.
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DOI: 10.1002/cpdd.1600
Abstract: Bexicaserin (LP352) is a selective 5-hydroxytryptamine 2C (5-HT2C) superagonist in development for the treatment of seizures in developmental and epileptic encephalopathies (DEEs). This double-blind, placebo-controlled, single ascending dose (SAD) Phase 1 study aimed to assess… read more here.
Keywords: bexicaserin; safety tolerability; placebo; study ... See more keywords
Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of an Omega‐3‐Carboxylic Acid Formulation in Healthy Male Japanese Subjects: A Phase 1 Single‐Blind, Randomized, Placebo‐Controlled Trial
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DOI: 10.1002/cpdd.360
Abstract: OM3‐CA (omega‐3‐carboxylic acids) is a complex mixture of omega‐3 carboxylic acids, particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which is approved in the United States for the treatment of hypertriglyceridemia. As part of its… read more here.
Keywords: placebo; omega carboxylic; safety tolerability; japanese subjects ... See more keywords