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• W2980757935 abstract "LY3154207, a D1 PAM, represents a novel mechanism of action that may improve dementia symptoms by increasing the affinity of dopamine for the D1 receptor and amplifying the endogenous dopamine response. A previous single-ascending dose study of LY3154207 (25-200 mg) in healthy subjects showed acceptable tolerability and acute dose-related increases in systolic and diastolic blood pressure (SBP and DBP) and pulse rate at doses ≥75-200 mg. This randomized, double-blind, placebo-controlled, parallel-arm study evaluated the pharmacokinetics (PK) and safety of once-daily oral doses of LY3154207 (15, 30, 75, or 150 mg) given for 14 days in Japanese and non-Japanese healthy subjects (N=48) (NCT02562768). For PK analysis, serial blood samples were collected on Days 1, 2, 7, and 14. Adverse events (AEs) were recorded throughout the study, and 24-hour ambulatory blood pressure monitoring (ABPM) profiles were collected on Days -1, 1, 2, 7, and 14. Exploratory assessments of cognition were also made. After 14 days of once-daily dosing, LY3154207 plasma concentrations peaked between 2–3 hours post-dose. Steady state was achieved at Day 7. There was modest accumulation with the 15-mg dose (accumulation ratio based on AUC = 1.34) and no accumulation at higher doses. Across all dose levels, the range of total body clearance was 24.2−34.5 L/hour and renal clearance was minimal at 0.00244 - 0.00362 L/hour. No serious AEs occurred. Common treatment-related AEs (≥ 3 occurrences, primarily at the 150-mg dose) were mild in severity and included: insomnia, dizziness, nausea, nervousness, and palpitations. Dose-related increases in mean ABPM-derived SBP, DBP, and heart rate were noted on Day 1, with peak increases generally between 4–8 hours postdose. By Day 14 (Day 7 for lower LY3154207 doses), the magnitude of these increases was lower than at Day 1 and in the range observed with placebo, suggesting accommodation of these cardiovascular effects. Overall, multiple once-daily doses of LY3174207 were well-tolerated with a PK profile predictable from single doses. An acute dose-dependent increase in SBP, DBP, and HR was observed upon initial administration but these effects accommodated with repeated dosing." @default.
• W2980757935 created "2019-10-25" @default.
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• W2980757935 date "2019-07-01" @default.
• W2980757935 modified "2023-09-27" @default.
• W2980757935 title "P1-057: A MULTIPLE ASCENDING-DOSE STUDY OF THE PHARMACOKINETICS AND SAFETY OF LY3154207, A CENTRALLY-ACTING DOPAMINE D1 RECEPTOR POSITIVE ALLOSTERIC MODULATOR (D1 PAM), IN HEALTHY SUBJECTS" @default.
• W2980757935 doi "https://doi.org/10.1016/j.jalz.2019.06.082" @default.
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