SG11201907854VA - Concomitant administration of glucocorticoid receptor modulators and cyp3a inhibitors - Google Patents
Concomitant administration of glucocorticoid receptor modulators and cyp3a inhibitorsInfo
- Publication number
- SG11201907854VA SG11201907854VA SG11201907854VA SG11201907854VA SG11201907854VA SG 11201907854V A SG11201907854V A SG 11201907854VA SG 11201907854V A SG11201907854V A SG 11201907854VA SG 11201907854V A SG11201907854V A SG 11201907854VA SG 11201907854V A SG11201907854V A SG 11201907854VA
- Authority
- SG
- Singapore
- Prior art keywords
- inhibitors
- grm
- international
- applicant
- administration
- Prior art date
Links
- 229940117965 Glucocorticoid receptor modulator Drugs 0.000 title abstract 9
- 208000009011 Cytochrome P-450 CYP3A Inhibitors Diseases 0.000 title abstract 4
- 239000003112 inhibitor Substances 0.000 abstract 8
- VHVPQPYKVGDNFY-DFMJLFEVSA-N 2-[(2r)-butan-2-yl]-4-[4-[4-[4-[[(2r,4s)-2-(2,4-dichlorophenyl)-2-(1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-1,2,4-triazol-3-one Chemical compound O=C1N([C@H](C)CC)N=CN1C1=CC=C(N2CCN(CC2)C=2C=CC(OC[C@@H]3O[C@](CN4N=CN=C4)(OC3)C=3C(=CC(Cl)=CC=3)Cl)=CC=2)C=C1 VHVPQPYKVGDNFY-DFMJLFEVSA-N 0.000 abstract 3
- 206010067484 Adverse reaction Diseases 0.000 abstract 3
- 230000006838 adverse reaction Effects 0.000 abstract 3
- 239000003814 drug Substances 0.000 abstract 3
- 229960004130 itraconazole Drugs 0.000 abstract 3
- 229960003248 mifepristone Drugs 0.000 abstract 3
- XMAYWYJOQHXEEK-OZXSUGGESA-N (2R,4S)-ketoconazole Chemical compound C1CN(C(=O)C)CCN1C(C=C1)=CC=C1OC[C@@H]1O[C@@](CN2C=NC=C2)(C=2C(=CC(Cl)=CC=2)Cl)OC1 XMAYWYJOQHXEEK-OZXSUGGESA-N 0.000 abstract 2
- 239000003795 chemical substances by application Substances 0.000 abstract 2
- 229940079593 drug Drugs 0.000 abstract 2
- 229960004125 ketoconazole Drugs 0.000 abstract 2
- VKHAHZOOUSRJNA-GCNJZUOMSA-N mifepristone Chemical compound C1([C@@H]2C3=C4CCC(=O)C=C4CC[C@H]3[C@@H]3CC[C@@]([C@]3(C2)C)(O)C#CC)=CC=C(N(C)C)C=C1 VKHAHZOOUSRJNA-GCNJZUOMSA-N 0.000 abstract 2
- 230000010009 steroidogenesis Effects 0.000 abstract 2
- 230000001988 toxicity Effects 0.000 abstract 2
- 231100000419 toxicity Toxicity 0.000 abstract 2
- 208000014311 Cushing syndrome Diseases 0.000 abstract 1
- 206010028980 Neoplasm Diseases 0.000 abstract 1
- 201000010099 disease Diseases 0.000 abstract 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract 1
- 229940088597 hormone Drugs 0.000 abstract 1
- 239000005556 hormone Substances 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 230000008520 organization Effects 0.000 abstract 1
- 201000009395 primary hyperaldosteronism Diseases 0.000 abstract 1
- 102220240796 rs553605556 Human genes 0.000 abstract 1
Classifications
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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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K31/567—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in position 17 alpha, e.g. mestranol, norethandrolone
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/38—Drugs for disorders of the endocrine system of the suprarenal hormones
- A61P5/46—Drugs for disorders of the endocrine system of the suprarenal hormones for decreasing, blocking or antagonising the activity of glucocorticosteroids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Endocrinology (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Emergency Medicine (AREA)
- Zoology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Molecular Biology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Details Of Resistors (AREA)
Abstract
INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 07 September 2018 (07.09.2018) WIP0 I PCT omit VIII °nolo VIII ioo im mown° oimIE (10) International Publication Number WO 2018/160775 Al (51) International Patent Classification: A61K 31/56 (2006.01) A61P 43/00 (2006.01) A61K 31/497 (2006.01) (21) International Application Number: PCT/US2018/020336 (22) International Filing Date: 28 February 2018 (28.02.2018) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 62/465,772 01 March 2017 (01.03.2017) US 62/466,867 03 March 2017 (03.03.2017) US (71) Applicant: CORCEPT THERAPEUTICS, INC. [US/US]; 149 Commonwealth Drive, Menlo Park, Califor- nia 94025 (US). (72) Inventor: BELANOFF, Joseph K.; 149 Commonwealth Drive, Menlo Park, California 94025 (US). (74) Agent: WEBER, Kenneth A. et al.; Kilpatrick Townsend & Stockton LLP, Mailstop: IP Docketing - 22, 1100 Peachtree Street, Suite 2800, Atlanta, Georgia 30309 (US). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, (54) Title: CONCOMITANT ADMINISTRATION OF GLUCOCORTICOID RECEPTOR MODULATORS AND CYP3A INHIBI- TORS 3000 Ana ly te Plasma Concen tra t ion ( ng lm L) — e— Mifepristone — o— RU42633 —v— RU42698 RU42848 2500 - 2000 - 1500 - 1000 - 500 - N N O 00 O C llllllll I I I 14 21 28 Study Day FIG. 1 (57) : Applicant provides methods of treating diseases including Cushing's syndrome and hormone-sensitive cancers by con- comitant administration of a glucocorticoid receptor modulator (GRM) and steroidogenesis inhibitors, and by concomitant administra- tion of a GRM and CYP3A inhibitors. The GRM may be, e.g., mifepristone; the CYP3A inhibitors or steroidogenesis inhibitors (col- lectively \"inhibitors\") may be, e.g., ketoconazole or itraconazole. Inhibitors may cause toxicity or other serious adverse reactions; con- comitant administration of inhibitors with other drugs may increase the risk of such toxicity and adverse reactions due to the inhibitors and/or the other drugs. Applicant has surprisingly found that GRMs may be administered to subjects receiving inhibitors without in- creasing the risk of adverse reactions; for example, Applicant has found that mifepristone may be concomitantly administered with ke- toconazole or itraconazole, providing safe concomitant administration of the GRM and ketoconazole or itraconazole. In embodiments, [Continued on next page] WO 2018/160775 Al MIDEDIMOMOIDEIREEMOMOHINNEMOIMEN OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). Published: — with international search report (Art. 21(3)) the GRM dose may be reduced during concomitant administration of the GRM with inhibitors.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201762465772P | 2017-03-01 | 2017-03-01 | |
| US201762466867P | 2017-03-03 | 2017-03-03 | |
| PCT/US2018/020336 WO2018160775A1 (en) | 2017-03-01 | 2018-02-28 | Concomitant administration of glucocorticoid receptor modulators and cyp3a inhibitors |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| SG11201907854VA true SG11201907854VA (en) | 2019-09-27 |
Family
ID=59958459
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SG11201907854VA SG11201907854VA (en) | 2017-03-01 | 2018-02-28 | Concomitant administration of glucocorticoid receptor modulators and cyp3a inhibitors |
Country Status (11)
| Country | Link |
|---|---|
| US (7) | US10195214B2 (en) |
| EP (1) | EP3589288A4 (en) |
| JP (3) | JP7218294B2 (en) |
| KR (1) | KR102532583B1 (en) |
| CN (1) | CN110352058A (en) |
| AU (1) | AU2018229355B2 (en) |
| CA (1) | CA3052668A1 (en) |
| IL (1) | IL269009B2 (en) |
| MX (1) | MX2019010338A (en) |
| SG (1) | SG11201907854VA (en) |
| WO (1) | WO2018160775A1 (en) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10195214B2 (en) | 2017-03-01 | 2019-02-05 | Corcept Therapeutics, Inc. | Concomitant administration of glucocorticoid receptor modulators and CYP3A inhibitors |
| WO2021242916A1 (en) * | 2020-05-27 | 2021-12-02 | Corcept Therapeutics Incorporated | Concomitant administration of glucocorticoid receptor modulator relacorilant and cyp2c9 substrates |
| KR20230017829A (en) | 2020-05-27 | 2023-02-06 | 코어셉트 쎄라퓨틱스 인코포레이티드 | Concomitant administration of the glucocorticoid receptor modulator relacorilant and paclitaxel, a dual substrate of CYP2C8 and CYP3A4 |
| WO2023225282A1 (en) * | 2022-05-20 | 2023-11-23 | Corcept Therapeutics Incorporated | Methods of treating cushing's syndrome and liver disorders, and of reducing liver toxicity of other drugs administered to a patient |
Family Cites Families (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20020016293A1 (en) | 2000-04-21 | 2002-02-07 | Ratain Mark J. | Flavopiridol drug combinations and methods with reduced side effects |
| US7163934B2 (en) | 2001-05-04 | 2007-01-16 | Corcept Therapeutics, Inc. | Methods for treating delirium glucocorticoid receptor-specific antagonists |
| US20070254025A1 (en) | 2006-04-27 | 2007-11-01 | Cronk Peter J | Oral contraceptive and acne medication combination and treatment of acne with reduced side effects |
| EP1886695A1 (en) | 2006-06-27 | 2008-02-13 | Speedel Experimenta AG | Pharmaceutical combination of an aldosterone synthase inhibitor and a glucocorticoid receptor antagonist or a cortisol synthesis inhibitor or a corticotropin releasing factor antagonist |
| KR20090068345A (en) | 2006-10-23 | 2009-06-26 | 머크 앤드 캄파니 인코포레이티드 | 2-[1-phenyl-5-hydroxy-4alpha-methyl-hexahydrocyclopenta[f]indazol-5-yl]ethyl phenyl derivatives as glucocorticoid receptor ligands |
| US8598149B2 (en) | 2007-08-30 | 2013-12-03 | Corcept Therapeutics, Inc. | Optimizing mifepristone levels in plasma serum of patients suffering from mental disorders treatable with glucocorticoid receptor antagonists |
| EP2211845B1 (en) | 2007-10-17 | 2017-02-22 | Laboratoire HRA Pharma | Glucocorticoid receptor antagonists such as mifepristone for treating cushing's syndrome |
| ES2382618T3 (en) * | 2008-03-25 | 2012-06-11 | Formac Pharmaceuticals N.V. | Preparation method for solid dispersions |
| GB2477256B (en) | 2008-11-07 | 2013-12-25 | Univ Sheffield | Determination of predisposition towards subclinical Cushing's syndrome or incidentaloma |
| US20100135956A1 (en) | 2008-11-21 | 2010-06-03 | Auspex Pharmaceuticals, Inc. | Steroid modulators of progesterone receptor and/or glucocorticoid receptor |
| HUE052510T2 (en) | 2009-05-27 | 2021-05-28 | Ptc Therapeutics Inc | Methods for treating cancer and non-neoplastic conditions |
| WO2011051894A1 (en) * | 2009-10-29 | 2011-05-05 | Aventis Pharma S.A. | Novel antitumoral use of cabazitaxel |
| IL284291B1 (en) * | 2014-12-19 | 2024-10-01 | Lundbeck Seattle Biopharmaceuticals Inc | Humanized anti-acth antibodies and use thereof |
| US9943526B2 (en) | 2015-04-21 | 2018-04-17 | Corcept Therapeutics, Inc. | Optimizing mifepristone levels for cushing's patients |
| US10604807B2 (en) | 2015-05-18 | 2020-03-31 | Corcept Therapeutics, Inc. | Methods for diagnosing and assessing treatment for Cushing's syndrome |
| US10195214B2 (en) | 2017-03-01 | 2019-02-05 | Corcept Therapeutics, Inc. | Concomitant administration of glucocorticoid receptor modulators and CYP3A inhibitors |
-
2017
- 2017-06-19 US US15/627,359 patent/US10195214B2/en active Active
- 2017-06-19 US US15/627,368 patent/US20170281651A1/en not_active Abandoned
-
2018
- 2018-02-28 KR KR1020197028226A patent/KR102532583B1/en active IP Right Grant
- 2018-02-28 US US16/482,656 patent/US20200147107A1/en not_active Abandoned
- 2018-02-28 SG SG11201907854VA patent/SG11201907854VA/en unknown
- 2018-02-28 EP EP18760940.9A patent/EP3589288A4/en active Pending
- 2018-02-28 IL IL269009A patent/IL269009B2/en unknown
- 2018-02-28 WO PCT/US2018/020336 patent/WO2018160775A1/en unknown
- 2018-02-28 MX MX2019010338A patent/MX2019010338A/en unknown
- 2018-02-28 CA CA3052668A patent/CA3052668A1/en active Pending
- 2018-02-28 CN CN201880014847.1A patent/CN110352058A/en active Pending
- 2018-02-28 AU AU2018229355A patent/AU2018229355B2/en active Active
- 2018-02-28 JP JP2019547316A patent/JP7218294B2/en active Active
- 2018-12-13 US US16/219,564 patent/US10842800B2/en active Active
-
2021
- 2021-12-07 US US17/544,859 patent/US11969435B2/en active Active
-
2023
- 2023-01-25 JP JP2023009317A patent/JP7516586B2/en active Active
- 2023-09-01 US US18/241,364 patent/US12097210B2/en active Active
-
2024
- 2024-06-11 US US18/740,218 patent/US20240358718A1/en active Pending
- 2024-07-03 JP JP2024107398A patent/JP2024127949A/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| IL269009B1 (en) | 2023-10-01 |
| US20190117676A1 (en) | 2019-04-25 |
| US20170281651A1 (en) | 2017-10-05 |
| EP3589288A1 (en) | 2020-01-08 |
| KR20190122239A (en) | 2019-10-29 |
| IL269009A (en) | 2019-10-31 |
| CA3052668A1 (en) | 2018-09-07 |
| WO2018160775A1 (en) | 2018-09-07 |
| CN110352058A (en) | 2019-10-18 |
| US12097210B2 (en) | 2024-09-24 |
| US11969435B2 (en) | 2024-04-30 |
| JP2024127949A (en) | 2024-09-20 |
| JP2020509032A (en) | 2020-03-26 |
| US20200147107A1 (en) | 2020-05-14 |
| US20170326157A1 (en) | 2017-11-16 |
| MX2019010338A (en) | 2019-10-14 |
| AU2018229355B2 (en) | 2024-02-15 |
| US10195214B2 (en) | 2019-02-05 |
| US20240358718A1 (en) | 2024-10-31 |
| US20230414635A1 (en) | 2023-12-28 |
| IL269009B2 (en) | 2024-02-01 |
| KR102532583B1 (en) | 2023-05-12 |
| JP7218294B2 (en) | 2023-02-06 |
| JP7516586B2 (en) | 2024-07-16 |
| AU2018229355A1 (en) | 2019-08-15 |
| JP2023052618A (en) | 2023-04-11 |
| US10842800B2 (en) | 2020-11-24 |
| EP3589288A4 (en) | 2020-12-30 |
| US20220088036A1 (en) | 2022-03-24 |
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