JP5674854B2 - (R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミド及びその製薬上許容しうる塩を用いた認知障害の治療 - Google Patents
(R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミド及びその製薬上許容しうる塩を用いた認知障害の治療 Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/439—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom the ring forming part of a bridged ring system, e.g. quinuclidine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4406—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 3, e.g. zimeldine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
- A61K31/4462—Non condensed piperidines, e.g. piperocaine only substituted in position 3
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/26—Psychostimulants, e.g. nicotine, cocaine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2121/00—Preparations for use in therapy
Description
以下に、(R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミドが、1 mg以下の予想外に低い1日投与量で認知機能に対して陽性効果を誘発することを実証するヒト臨床試験を記載する。陽性効果は、統合失調症に罹患した患者及び正常被験者の両方で観察される。また、((R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミド塩酸塩の)1日1 mg投与量でヒトに投与された(R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミドの遊離濃度は、認知機能に対して陽性効果を発現する、又は統合失調症患者において認知機能及び機能的パフォーマンス(cognitive and functional performance)の改善と相関する感覚電気生理学的反応(sensory electrophysiological responses)を改善しうるために必要と予測されるよりも、少なくとも1オーダー低いことを示す研究を以下に記載する。また、(R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミドが、動物における前臨床試験に基づいて予測される半減期に比べて、ヒトにおいて予想外に長い半減期を有することを実証する研究を以下に記載する。
以下に記載する研究は、(R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミド塩酸塩が、統合失調症患者において認知機能及び機能的パフォーマンスの改善と相関する感覚電気生理学的反応を改善しうることを実証する。これらの効果は、0.3 mgという低い1日投与量で観察された。
上記の試験は、統合失調症に罹患した患者における認知機能に対する試験化合物の効果を研究するために使用された。試験の前に、患者は、試験化合物を1日1 mg、試験化合物を1日0.3 mg又はプラセボを20日間投与された。以下に記載するように被験者を試験した。
正常被験者における認知機能に対する試験化合物の影響を以下に記載するように評価した。これらの試験被験者は、クランベリージュースに溶解した試験化合物で処置した。
上記の研究は、1.0 mg又は0.3 mgの1日投与量で投与された(R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミド塩酸塩が統合失調症に罹患した患者及び正常被験者における認知機能を改善しうることを実証する。
表2は、(R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミドの前臨床種から得た半減期(t1/2)のデータ及び臨床試験で測定されたヒトにおける半減期を示す。
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本発明によれば、以下の態様が提供される。
[1] (R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミド又はその製薬上許容しうる塩を3 mg未満の1日投与量で対象に投与することからなる、認知機能を改善する方法。
[2] 1日投与量が1 mg以下である[1]記載の方法。
[3] 1日投与量が0.3 mg以下である[2]記載の方法。
[4] (R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミド又はその製薬上許容しうる塩を3 mg未満の1日投与量で対象に投与することからなる、認知障害の治療方法。
[5] 1日投与量が1 mg以下である[4]記載の方法。
[6] 1日投与量が0.3 mg以下である[5]記載の方法。
[7] (R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミド又はその製薬上許容しうる塩を3 mg未満の1日投与量で対象に投与することからなる、統合失調症、統合失調症様障害、統合失調感情障害、及び妄想性障害から選択される障害の治療方法。
[8] 1日投与量が1 mg以下である[7]記載の方法。
[9] 1日投与量が0.3 mg以下である[8]記載の方法。
[10] (R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミド又はその製薬上許容しうる塩を3 mg未満の1日投与量で対象に投与することからなる、学習、遅延記憶、作業記憶、視覚学習、処理速度、ビジランス、言語学習、視覚運動機能、社会的認知、長期記憶又は実行機能の1つ以上を改善する方法。
[11] 1日投与量が1 mg以下である[10]記載の方法。
[12] 1日投与量が0.3 mg以下である[11]記載の方法。
[13] (R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミド又はその製薬上許容しうる塩を3 mg未満の1日投与量で対象に投与することからなる、実行機能を改善する方法。
[14] 1日投与量が1 mg以下である[13]記載の方法。
[15] 1日投与量が0.3 mg以下である[14]記載の方法。
[16] (R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミド又はその製薬上許容しうる塩を3 mg未満の1日投与量で対象に投与することからなる、アルツハイマー病の1以上の症状を治療する方法。
[17] 1日投与量が1 mg以下である[16]記載の方法。
[18] 1日投与量が0.3 mg以下である[17]記載の方法。
[19] (R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミド又はその製薬上許容しうる塩を3 mg未満の1日投与量で対象に投与することからなる、視覚運動スキル、学習、実行機能、及び遅延記憶の1つ以上を改善する方法。
[20] 1日投与量が1 mg以下である[19]記載の方法。
[21] 1日投与量が0.3 mg以下である[20]記載の方法。
[22] (R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミド又はその製薬上許容しうる塩を3 mg未満の1日投与量で対象に投与することからなる、注意、学習、遅延記憶、作業記憶、視覚学習、処理速度、ビジランス、言語学習、視覚運動機能、社会的認知、長期記憶又は実行機能の1つ以上を改善する方法。
[23] 1日投与量が1 mg以下である[10]記載の方法。
[24] 1日投与量が0.3 mg以下である[11]記載の方法。
[25] 対象が不安又は興奮の症状を有する前記のいずれか1項に記載の方法。
[26] 0.3乃至3.0 mgの(R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミド又はその製薬上許容しうる塩、及び製薬上許容しうる担体を含有する単位投与量医薬組成物。
[27] 0.3乃至1.5 mgの(R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミド又はその製薬上許容しうる塩、及び製薬上許容しうる担体を含有する単位投与量医薬組成物。
[28] 1 mgの(R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミド又はその製薬上許容しうる塩、及び製薬上許容しうる担体を含有する単位投与量医薬組成物。
Claims (8)
- (R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミド又はその製薬上許容しうる塩を含有する、アルツハイマー病又は統合失調症の患者における認知障害の治療用医薬であって、(R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミド又はその製薬上許容しうる塩が0.1 mg〜3 mgの経口1日投与量で患者に投与されるように用いられる、医薬。
- 経口1日投与量が0.3 mg〜3 mgである請求項1記載の医薬。
- 経口1日投与量が1 mg〜3 mgである請求項1記載の医薬。
- 経口1日投与量が0.3 mg、1 mg、2 mg又は3 mgである請求項1記載の医薬。
- 統合失調症が妄想型、解体型、緊張型及び未分化型から選択される、請求項1記載の医薬。
- (R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミドの製薬上許容しうる塩が、(R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミド塩酸塩、(R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミド塩酸塩一水和物、及び(R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミド塩酸塩溶媒和物から選択される、請求項1〜5のいずれか1項に記載の医薬。
- (R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミドの製薬上許容しうる塩が、(R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミド塩酸塩である、請求項1〜5のいずれか1項に記載の医薬。
- (R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミドの製薬上許容しうる塩が、(R)−7−クロロ−N−(キヌクリジン−3−イル)ベンゾ[b]チオフェン−2−カルボキサミド塩酸塩一水和物である、請求項1〜5のいずれか1項に記載の医薬。
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