EXCLUSIVE: Adial Pharmaceuticals Reveals Topline Results From Pharmacokinetics Study Of AD04 For Alcohol Use Disorder
EXCLUSIVE: Adial Pharmaceuticals Reveals Topline Results From Pharmacokinetics Study Of AD04 For Alcohol Use Disorder
Thursday, Adial Pharmaceuticals Inc (NASDAQ:ADIL) said it has completed a pharmacokinetics (PK) study of AD04 for Alcohol Use Disorder (AUD) in heavy drinking patients (defined as less than ten drinks/drinking day).
週四，Adial Pharmaceuticals Inc（納斯達克股票代碼：ADIL）表示，它已經完成了對AD04治療重度飲酒患者（定義爲每天少於十杯）酒精使用障礙（澳元）的藥代動力學（PK）研究。
This data will help the company optimize study design elements needed for the upcoming Phase 3 clinical trial of AD04.
這些數據將幫助該公司優化即將到來的AD04三期臨床試驗所需的研究設計元素。
Completing the study also satisfied an FDA requirement for the upcoming Phase 3 trials of AD04.
完成該研究還滿足了美國食品藥品管理局對即將進行的AD04三期試驗的要求。
Also Read: EXCLUSIVE: Adial Pharmaceuticals Advances Regulatory Strategy For Companion Diagnostic Genetic Test For Its Lead Program For Alcohol Use Disorder
另請閱讀：獨家：Adial Pharmicals推進了其酒精使用障礙主要計劃的伴隨診斷基因檢測的監管戰略
The single-center, relative bioavailability, open-label study enrolled 30 healthy adult volunteers in two cohorts.
這項單中心、相對生物利用度、開放標籤的研究在兩個隊列中招收了30名健康的成年志願者。
Cohort 1 (n=6) was a randomized, open-label, 2-sequence, 2-period crossover study to evaluate the PK variability of ondansetron from AD04 0.33 and 0.99mg.
隊列1（n=6）是一項隨機、開放標籤、雙序列、兩週期的交叉研究，旨在評估恩丹司瓊在AD04 0.33和0.99mg之間的Pk變異性。
Cohort 2 (n=24) was a randomized, open-label, 6-sequence, 4-period crossover study to evaluate the relative bioavailability of the AD04 0.33mg tablet to a marketed ondansetron 4mg tablet, dose proportionality of ondansetron PK between AD04 0.33 and 0.99mg, and the effect of food on the bioavailability of ondansetron administered as the AD04 0.33mg tablet.
隊列2（n=24）是一項隨機、開放標籤、6個序列、4個週期的交叉研究，旨在評估AD04 0.33mg片劑與上市的恩丹西酮4mg片劑的相對生物利用度、恩丹西酮Pk的劑量比例介於AD04 0.33mg和0.99mg之間，以及食物對以AD04 0.33mg片劑的形式給藥的恩丹司瓊生物利用度的影響。
The results of this study showed that, due to the lower dose, AD04 0.33mg delivered lower ondansetron PK exposure than the marketed reference standard ondansetron 4mg tablet; ondansetron pharmacokinetic exposure increased in proportion to dose across a 3–fold AD04 dose range; and AD04 can be taken in fed or fasted states.
這項研究的結果表明，由於劑量較低，AD04 0.33mg的恩丹西酮Pk暴露量低於市售的參考標準昂丹西酮4mg片劑；在AD04的3倍劑量範圍內，恩丹司瓊藥代動力學暴露量與劑量成比例增加；AD04可以在餵食或禁食狀態下服用。
Its completion is in accordance with previous guidance provided by the FDA. This relatively short and low-cost study was key to the strategy to advance ongoing partnership discussions.
其完成符合美國食品和藥物管理局先前提供的指導方針。這項相對較短且成本相對較低的研究是推進正在進行的夥伴關係討論的戰略的關鍵。
Additionally, the study will provide data necessary to support an application for approval of AD04 under a 505(b)(2) regulatory pathway with the FDA.
此外，該研究將提供必要的數據，以支持根據美國食品和藥物管理局的505（b）（2）監管途徑申請AD04的批准。
The company plans to engage with the FDA during the fourth quarter of 2024 with the results of this pharmacokinetics study and obtain feedback that will assist with the AD04 Phase 3 study program.
該公司計劃在2024年第四季度與美國食品藥品管理局合作，提供這項藥代動力學研究的結果，並獲得反饋，這將有助於AD04的3期研究計劃。
Price Action: ADIL stock is down 0.01% at $0.99 during the premarket session at last check Thursday.
價格走勢：在週四最後一次盤前交易中，ADIL股價下跌0.01％，至0.99美元。
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