[Translation] An open, randomized, two-sequence, two-period, crossover design bioequivalence study of a single oral fasting dose of domestic lefamulin acetate tablets and imported lefamulin acetate tablets in healthy Chinese adult subjects

主要目的：评价健康受试者空腹单次口服地产醋酸来法莫林片（0.6g/片，无锡合全药业有限公司生产）和进口醋酸来法莫林片（ 0.6g/片，Almac Pharma Services Limited 生产）的生物等效性。次要目的：评价健康受试者空腹单次口服地产醋酸来法莫林片和进口醋酸来法莫林片的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of domestic lefamulin acetate tablets (0.6 g/tablet, produced by Wuxi Hequan Pharmaceutical Co., Ltd.) and imported lefamulin acetate tablets (0.6 g/tablet, produced by Almac Pharma Services Limited) in healthy subjects after a single oral administration on an empty stomach. Secondary objective: To evaluate the safety of domestic lefamulin acetate tablets and imported lefamulin acetate tablets in healthy subjects after a single oral administration on an empty stomach.

Start Date18 Feb 2024

Sponsor / Collaborator

Sumitomo Pharmaceuticals (Suzhou) Co., Ltd.

CTR20213353

/ TerminatedPhase 2/3

一项在精神分裂症急性精神障碍患者中评价 SEP-363856 的疗效和安全性的随机、双盲、平行组、安慰剂对照、固定剂量、多中心研究，之后进入开放性延长

[Translation] A randomized, double-blind, parallel-group, placebo-controlled, fixed-dose, multicenter study evaluating the efficacy and safety of SEP-363856 in patients with acute psychotic disorders of schizophrenia followed by an open-label extended

主要疗效目的通过测定阳性与阴性症状量表(PANSS)总评分，评价在急性精神分裂症患者中固定剂量SEP-363856与安慰剂相比的疗效次要疗效目的通过测定临床总体印象-严重程度(CGI-S)评分，评价在急性精神分裂症精神病患者中固定剂量SEP-363856与安慰剂相比的疗效其他疗效目的通过测定PANSS总评分及CGI-S评分评价在急性精神分裂症患者中灵活剂量SEP-363856的长期有效性；通过测定分量表/Marder因子/Lindenmayer五因子模型/PANSS UPSM因子等评分及简明阴性症状量表和Montgomery-Asberg抑郁评定量表的总评分评价在急性精神分裂症患者中固定剂量的疗效和灵活剂量SEP-363856的长期有效性安全性目的总体AE、严重AE，和导致停药的AE的发生率药代动力学目的利用血浆SEP-363856浓度进行群体药代动力学(POPPK)分析通过POPPK/药效学方法探索PANSS总评分和血浆SEP-363856暴露量之间的关系探索CYP2D6代谢者状态对SEP-363856血浆暴露量的影响完成6周双盲期的患者可以进入12周的开放期

[Translation]

Primary efficacy objective To evaluate the efficacy of fixed-dose SEP-363856 compared with placebo in patients with acute schizophrenia by measuring the total score of the Positive and Negative Syndrome Scale (PANSS) Secondary efficacy objectives To evaluate the efficacy of fixed-dose SEP-363856 compared with placebo in patients with acute schizophrenia psychosis by measuring the Clinical Global Impression-Severity (CGI-S) score Other efficacy objectives To evaluate the long-term effectiveness of flexible-dose SEP-363856 in patients with acute schizophrenia by measuring the total score of PANSS and CGI-S score; UPSM factor scores and the total scores of the Brief Negative Symptom Scale and the Montgomery-Asberg Depression Rating Scale were used to evaluate the efficacy of fixed doses and the long-term effectiveness of flexible dose SEP-363856 in patients with acute schizophrenia. Safety objectives Incidence of overall AEs, serious AEs, and AEs leading to discontinuation Pharmacokinetic objectives Population pharmacokinetic (POPPK) analysis using plasma SEP-363856 concentrations. The relationship between PANSS total score and plasma SEP-363856 exposure was explored by POPPK/pharmacodynamic methods. The effect of CYP2D6 metabolizer status on SEP-363856 plasma exposure was explored. Patients who completed the 6-week double-blind period were eligible to enter the 12-week open-label period.

Start Date02 Mar 2022

Sponsor / Collaborator

UPM Pharmaceuticals, Inc.

[+3]

CTR20213168

/ TerminatedPhase 1

在中国健康成年男性受试者中评估SEP-363856药代动力学的单次和多次口服给药、开放性研究

[Translation] A single and multiple oral dose, open-label study to evaluate the pharmacokinetics of SEP-363856 in healthy Chinese male adults

主要目的:评价中国健康成年男性受试者单次口服SEP-363856后血浆中SEP-363856及其代谢产物SEP-363854和SEP-383103的PK特征;评价中国健康成年男性受试者多次口服SEP-363856后血浆中SEP-363856及其代谢产物SEP-363854和SEP-383103的PK特征。次要目的:在中国健康成年男性受试者中评价SEP-363856单次口服给药后SEP-363856及其代谢物SEP-363854和SEP-383103的剂量与血浆浓度之间的关系。评价中国健康成年男性受试者单次口服SEP-363856后尿液中SEP-363856及其代谢产物SEP-363854和SEP-383103的PK特征。评价中国健康成年男性受试者多次口服SEP-363856后第1天和第7天SEP-363856和其代谢物SEP-363854和SEP-383103的血浆浓度之间的关系。安全性:评价SEP-363856单次口服给药后的安全性。评价SEP-363856多次口服给药后安全性。其他：探索CYP2D6代谢型对SEP-363856血浆浓度的影响。评价 SEP-363856对运动的影响

[Translation]

Primary objective: To evaluate the PK characteristics of SEP-363856 and its metabolites SEP-363854 and SEP-383103 in plasma after a single oral administration of SEP-363856 in healthy Chinese male adult subjects; to evaluate the PK characteristics of SEP-363856 and its metabolites SEP-363854 and SEP-383103 in plasma after multiple oral administrations of SEP-363856 in healthy Chinese male adult subjects. Secondary objective: To evaluate the relationship between dose and plasma concentration of SEP-363856 and its metabolites SEP-363854 and SEP-383103 after a single oral administration of SEP-363856 in healthy Chinese male adult subjects. To evaluate the PK characteristics of SEP-363856 and its metabolites SEP-363854 and SEP-383103 in urine after a single oral administration of SEP-363856 in healthy Chinese male adult subjects. To evaluate the relationship between the plasma concentrations of SEP-363856 and its metabolites SEP-363854 and SEP-383103 on the 1st and 7th days after multiple oral administration of SEP-363856 in healthy Chinese adult male subjects. Safety: To evaluate the safety of SEP-363856 after a single oral administration. To evaluate the safety of SEP-363856 after multiple oral administration. Others: To explore the effect of CYP2D6 metabolizer on the plasma concentration of SEP-363856. To evaluate the effect of SEP-363856 on exercise

Start Date10 Dec 2021

Sponsor / Collaborator

Sumitomo Pharmaceuticals (Suzhou) Co., Ltd.

[+3]

100 Clinical Results associated with Sumitomo Pharmaceuticals (Suzhou) Co., Ltd.

0 Patents (Medical) associated with Sumitomo Pharmaceuticals (Suzhou) Co., Ltd.

Literatures (Medical) associated with Sumitomo Pharmaceuticals (Suzhou) Co., Ltd.

01 Jun 2020·PSYCHIATRY AND CLINICAL NEUROSCIENCES

Randomized, double-blind, 6-week non-inferiority study of lurasidone and risperidone for the treatment of schizophrenia.

Article

Author: Liu, Qi ; Tan, Yunlong ; Liu, Xuejun ; Li, Keqing ; Wang, Xiaoliang ; Zhang, Xia ; Xu, Xiufeng ; Luo, Xiaoyan ; Shi, Jianguo ; Feng, Yuan ; Deng, Wei ; Ning, Yuping ; Wang, Lili ; Wang, Gang ; Xie, Shiping ; Li, Lehua ; Zhao, Jingyuan

AIM:

The aim of the present study was to evaluate the efficacy and safety of lurasidone for the treatment of Chinese schizophrenic patients.

METHODS:

Hospitalized schizophrenia patients aged 18-65 were randomized to 6 weeks of double-blind, double-dummy, flexible-dose treatment with lurasidone (40 or 80 mg/day) or risperidone (2, 4 or 6 mg/day). Efficacy was evaluated using a non-inferiority comparison of lurasidone relative to risperidone based on week 6 change in the Positive and Negative Syndrome Scale (PANSS) total score. Safety assessments included adverse events, clinical laboratory measures, and electrocardiograms.

RESULTS:

Four hundred and forty-four patients were screened to obtain an intent-to-treat sample of 384 patients, of whom 54 patients discontinued treatment prior to 6 weeks. Lurasidone met the criteria for non-inferiority versus risperidone on the PANSS total score. Adjusted mean (SE) change at week 6 on the PANSS total score was -31.2 (1.0) and -34.9 (1.0) in the lurasidone and risperidone group, respectively. The mean difference score was 3.7, and the upper boundary of the 95%-confidence interval (1.0-6.3) was less than the prespecified margin of 7.0. No clinically meaningful between-treatment group differences were evident on secondary efficacy measures, including PANSS positive, PANSS negative, Clinical Global Impression scale - Severity, and Calgary Depression Scale for Schizophrenia scales. The incidence of adverse events was lower for lurasidone vs risperidone for extrapyramidal symptoms (17.0% vs 38.2%), akathisia (7.2% vs 13.6%), prolactin increase (3.1% vs 14.1%), and weight increase (0.5% vs 5.2%).

CONCLUSION:

Lurasidone was found to be non-inferior to risperidone on the primary endpoint with minimal effects on weight, metabolic parameters, or prolactin levels.

BMC Psychiatry

Effectiveness and safety of blonanserin in young and middle-aged female patients with schizophrenia: data from a post-marketing surveillance

Article

Author: Zhan, Guilai ; Bo, Qijing ; Zhao, Guijun ; Cai, Duanfang ; Zhang, Ruiling ; Sang, Hong ; Li, Haiyun ; Yang, Xiaodong ; Li, Juhong ; Deng, Huaili ; Wang, Xijin ; Liu, Xianglai ; Wang, Gang ; Liu, Xuejun ; Xun, Zhiyuan ; Li, Keqing ; Chen, Jindong ; Sun, Meijuan

Abstract:

Background:

A post-marketing surveillance of blonanserin has been ongoing since September 2018. The aim of this study was to assess the effectiveness and safety of oral blonanserin in Chinese young and middle-aged female patients with schizophrenia in real clinical settings, using the data from the post-marketing surveillance.

Methods:

A 12-week, prospective, multi-center, open-label, post-marketing surveillance was conducted. Female patients aged 18–40 years were included in this analysis. The Brief Psychiatric Rating Scale (BPRS) was used to evaluate the effectiveness of blonanserin in improving psychiatric symptoms. The incidence of adverse drug reactions (ADRs) such as of extrapyramidal symptoms (EPS), prolactin elevation and the weight gain were used to evaluate the safety profile of blonanserin.

Results:

A total of 392 patients were included both in the safety and full analysis sets, 311 patients completed the surveillance protocol. The BPRS total score was 48.8 ± 14.11 at the baseline, decreasing to 25.5 ± 7.56 at 12 weeks (P < 0.001, compared with baseline). EPS (20.2%) including akathisia, tremor, dystonia, and parkinsonism were found as the most frequent ADRs. The mean weight gain was 0.27 ± 2.5 kg at 12 weeks from the baseline. Four cases (1%) of prolactin elevation were observed during the period of surveillance.

Conclusion:

Blonanserin significantly improved the symptoms of schizophrenia in female patients aged 18–40 years; the drug was well tolerated and had a low tendency to cause metabolic side effects, including prolactin elevation in these patients. Blonanserin might be a reasonable drug for the treatment of schizophrenia in young and middle-aged female patients.

Frontiers in psychiatry

Improvement of social functioning in patients with first-episode schizophrenia using blonanserin treatment: a prospective, multi-centre, single-arm clinical trial

Article

Author: Yang, Fude ; Yu, Xin ; Deng, Hong ; Liu, Zhening ; Li, Haiyun ; Sheng, Jianhua ; Wu, Bin ; Pu, Chengcheng ; Wang, Lina ; Gao, Tianqi ; Hu, Shaohua ; Wang, Xijin

Objectives:

This clinical trial primarily aimed to investigate the effects of blonanserin on social functioning in patients with first-episode schizophrenia.

Methods:

In this prospective, multi-centre, single-arm clinical trial study, blonanserin (flexible oral dose ranging from 8mg to 24mg per day) was given 26 weeks. Outcome measures included the Personal and Social Performance (PSP) scale for evaluating social functioning, the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB) for measuring neurocognitive performance, and the Positive and Negative Syndrome Scale (PANSS) for assessing symptom severity. The primary endpoint was social function improvement evaluated by PSP scale at the end of blonanserin treatment. And the secondary endpoint was to validate the efficacy and neurocognitive effects of blonanserin. Adverse drug reactions (ADRs) were also recorded and analysed.

Results:

A total of 96 patients with first-episode schizophrenia were recruited and proceeded to analysis. Fifty-one participants (53.1%) completed the PSP scale measurements at baseline and week 26. Following 26 weeks of blonanserin treatment, all outcome measurements demonstrated significant improvement during the follow-up period. Notably, PSP scores exhibited a continuous increase up to 68.1% ± 103.7% at the end of the treatment (46.6 ± 14.6 at baseline, 69.4 ± 17.4 at week 26, p<0.001), indicating positive effects on social functioning that were already noticeable by week 8.

Conclusion:

Blonanserin treatment exhibited favourable effects on social functioning in individuals with first-episode schizophrenia. The results suggest that blonanserin was effective treatment options for patients with schizophrenia encountering functional impairments.

100 Deals associated with Sumitomo Pharmaceuticals (Suzhou) Co., Ltd.

100 Translational Medicine associated with Sumitomo Pharmaceuticals (Suzhou) Co., Ltd.

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Drug(Targets)	Indications	Global Highest Phase

Lefamulin Acetate ( 50S subunit )	Community-acquired bacterial pneumonia More	NDA/BLA
Lurasidone Hydrochloride ( 5-HT2A receptor x D2 receptor )	Bipolar and Related Disorders More	Phase 3
Ulotaront ( 5-HT1A receptor x TAAR1 )	Schizophrenia More	Discontinued

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