2022
DOI: 10.1016/j.clinthera.2022.07.008
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Pharmacokinetics, Pharmacodynamics, and Tolerability of Olpasiran in Healthy Japanese and Non-Japanese Participants: Results from a Phase I, Single-dose, Open-label Study

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Cited by 17 publications
(26 citation statements)
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“…24,40 The other phase 1 trial was an open-label, parallel-design study conducted in 27 healthy volunteers of Japanese and non-Japanese origin aged 18–60 years with a BMI of 18–32 kg/m 2 . 25 In the FIH study, subjects were randomized into an experimental group that received a single test dose of olpasiran (ie, 3 mg, 9 mg, 75 mg, or 225 mg) and a control group that received a single matching dose of placebo. 24 In the aforementioned other phase 1 trial, non-Japanese participants received a single 75-mg dose of olpasiran while Japanese subjects were randomly assigned to receive a single dose of 3 mg, 9 mg, 75 mg, or 225 mg of the same drug.…”
Section: Resultsmentioning
confidence: 99%
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“…24,40 The other phase 1 trial was an open-label, parallel-design study conducted in 27 healthy volunteers of Japanese and non-Japanese origin aged 18–60 years with a BMI of 18–32 kg/m 2 . 25 In the FIH study, subjects were randomized into an experimental group that received a single test dose of olpasiran (ie, 3 mg, 9 mg, 75 mg, or 225 mg) and a control group that received a single matching dose of placebo. 24 In the aforementioned other phase 1 trial, non-Japanese participants received a single 75-mg dose of olpasiran while Japanese subjects were randomly assigned to receive a single dose of 3 mg, 9 mg, 75 mg, or 225 mg of the same drug.…”
Section: Resultsmentioning
confidence: 99%
“…24,25 The most common side effects were generally mild-to-moderate and included fatigue, headache, myalgia, oropharyngeal pain, nasopharyngitis, pruritus, rash, aphthous ulcer, sweating, upper respiratory tract infections, upper-airway cough syndrome, and vitreous floaters. 25 No serious side effects including death were reported. 24,25…”
Section: Resultsmentioning
confidence: 99%
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