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
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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, 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
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
Safety, Tolerability, and Pharmacokinetics of 3 g of Ceftolozane/Tazobactam in Healthy Adults: A Randomized, Placebo‐Controlled, Multiple‐Dose Study
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DOI: 10.1002/cpdd.429
Abstract: Ceftolozane/tazobactam is an antibacterial approved at 1.5 g (1g/0.5 g) every 8 hours (q8h); higher doses may provide additional benefits in difficult‐to‐treat infections. We conducted a phase I trial in healthy adults evaluating safety, tolerability,… read more here.
Keywords: day; healthy adults; ceftolozane tazobactam; safety tolerability ... 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