Advanced Model-Based Approach to Evaluate Human Plasma, Cerebrospinal Fluid, and Neuronal mTORC1 Activation Biomarkers After NV-5138 Administration in Healthy Volunteers
Clin Ther. 2024 Mar 13:S0149-2918(24)00009-2. doi: 10.1016/j.clinthera.2023.12.015. Online ahead of print.ABSTRACTPURPOSE: NV-5138 ([S]-2-amino-5,5-difluoro-4,4-dimethylpentanoic acid) is an orally bioavailable, small-molecule activator of the mechanistic target of rapamycin complex 1 (mTORC1) pathway in development for treatment-resistant depression. The authors established a model to describe the relationship between plasma and cerebrospinal fluid (CSF) concentrations of NV-5138 and between CSF concentrations and potential biomarkers thought to be associated with mTORC1 activity (ie, orotic acid, N-acetylmethionine, and ...
Source: Clinical Therapeutics - March 14, 2024 Category: Drugs & Pharmacology Authors: Azmi Nasser J Randall Owen Roberto Gomeni Alisa R Kosheleff Jeanelle Portelli Lilian W Adeojo Thomas E Hughes Source Type: research
Advanced Model-Based Approach to Evaluate Human Plasma, Cerebrospinal Fluid, and Neuronal mTORC1 Activation Biomarkers After NV-5138 Administration in Healthy Volunteers
Clin Ther. 2024 Mar 13:S0149-2918(24)00009-2. doi: 10.1016/j.clinthera.2023.12.015. Online ahead of print.ABSTRACTPURPOSE: NV-5138 ([S]-2-amino-5,5-difluoro-4,4-dimethylpentanoic acid) is an orally bioavailable, small-molecule activator of the mechanistic target of rapamycin complex 1 (mTORC1) pathway in development for treatment-resistant depression. The authors established a model to describe the relationship between plasma and cerebrospinal fluid (CSF) concentrations of NV-5138 and between CSF concentrations and potential biomarkers thought to be associated with mTORC1 activity (ie, orotic acid, N-acetylmethionine, and ...
Source: Clinical Therapeutics - March 14, 2024 Category: Drugs & Pharmacology Authors: Azmi Nasser J Randall Owen Roberto Gomeni Alisa R Kosheleff Jeanelle Portelli Lilian W Adeojo Thomas E Hughes Source Type: research
Advanced Model-Based Approach to Evaluate Human Plasma, Cerebrospinal Fluid, and Neuronal mTORC1 Activation Biomarkers After NV-5138 Administration in Healthy Volunteers
Clin Ther. 2024 Mar 13:S0149-2918(24)00009-2. doi: 10.1016/j.clinthera.2023.12.015. Online ahead of print.ABSTRACTPURPOSE: NV-5138 ([S]-2-amino-5,5-difluoro-4,4-dimethylpentanoic acid) is an orally bioavailable, small-molecule activator of the mechanistic target of rapamycin complex 1 (mTORC1) pathway in development for treatment-resistant depression. The authors established a model to describe the relationship between plasma and cerebrospinal fluid (CSF) concentrations of NV-5138 and between CSF concentrations and potential biomarkers thought to be associated with mTORC1 activity (ie, orotic acid, N-acetylmethionine, and ...
Source: Clinical Therapeutics - March 14, 2024 Category: Drugs & Pharmacology Authors: Azmi Nasser J Randall Owen Roberto Gomeni Alisa R Kosheleff Jeanelle Portelli Lilian W Adeojo Thomas E Hughes Source Type: research
Thiazolidinediones Are Partially Effective Bitter Blockers
In this study, 2 TZDs were tested, rosiglitazone (ROSI) and a simpler form of TZD, using a high-potency sweetener as a positive control (neohesperidin dihydrochalcone, NHDC). We tested bitter-blocking effects using the bitter drugs tenofovir alafenamide fumarate (TAF), a treatment for HIV and hepatitis B infection, and praziquantel (PRAZ), a treatment for schistosomiasis, by conducting taste testing with 2 separate taste panels: a general panel (N = 97, 20-23 years, 82.5% female, all Eastern European) and a genetically informative panel (N = 158, including 68 twin pairs, 18-82 years, 76% female, 87% European ancestry). Par...
Source: Clinical Therapeutics - March 10, 2024 Category: Drugs & Pharmacology Authors: Ha Nguyen Cailu Lin Ivona Sasimovich Katherine Bell Amy Huang Emilia Leszkowicz Nancy E Rawson Danielle R Reed Source Type: research
Thiazolidinediones Are Partially Effective Bitter Blockers
In this study, 2 TZDs were tested, rosiglitazone (ROSI) and a simpler form of TZD, using a high-potency sweetener as a positive control (neohesperidin dihydrochalcone, NHDC). We tested bitter-blocking effects using the bitter drugs tenofovir alafenamide fumarate (TAF), a treatment for HIV and hepatitis B infection, and praziquantel (PRAZ), a treatment for schistosomiasis, by conducting taste testing with 2 separate taste panels: a general panel (N = 97, 20-23 years, 82.5% female, all Eastern European) and a genetically informative panel (N = 158, including 68 twin pairs, 18-82 years, 76% female, 87% European ancestry). Par...
Source: Clinical Therapeutics - March 10, 2024 Category: Drugs & Pharmacology Authors: Ha Nguyen Cailu Lin Ivona Sasimovich Katherine Bell Amy Huang Emilia Leszkowicz Nancy E Rawson Danielle R Reed Source Type: research
Thiazolidinediones Are Partially Effective Bitter Blockers
In this study, 2 TZDs were tested, rosiglitazone (ROSI) and a simpler form of TZD, using a high-potency sweetener as a positive control (neohesperidin dihydrochalcone, NHDC). We tested bitter-blocking effects using the bitter drugs tenofovir alafenamide fumarate (TAF), a treatment for HIV and hepatitis B infection, and praziquantel (PRAZ), a treatment for schistosomiasis, by conducting taste testing with 2 separate taste panels: a general panel (N = 97, 20-23 years, 82.5% female, all Eastern European) and a genetically informative panel (N = 158, including 68 twin pairs, 18-82 years, 76% female, 87% European ancestry). Par...
Source: Clinical Therapeutics - March 10, 2024 Category: Drugs & Pharmacology Authors: Ha Nguyen Cailu Lin Ivona Sasimovich Katherine Bell Amy Huang Emilia Leszkowicz Nancy E Rawson Danielle R Reed Source Type: research
Global Risdiplam Compassionate Use Program for Patients With Type 1 or 2 Spinal Muscular Atrophy
Clin Ther. 2024 Mar 8:S0149-2918(24)00061-4. doi: 10.1016/j.clinthera.2024.02.006. Online ahead of print.ABSTRACTPURPOSE: Spinal muscular atrophy (SMA) is a genetic neuromuscular disease causing progressive muscle weakness and reducing life expectancy. Risdiplam (Evrysdi; Genentech/F. Hoffmann-La Roche Ltd, Basel, Switzerland) is a drug approved for use in the treatment of patients with SMA. The ongoing global risdiplam Compassionate Use Program (CUP), initiated in November 2019, is the largest CUP in SMA, currently providing access to risdiplam for >2000 patients with type 1 or 2 SMA in 59 countries. Here, the challeng...
Source: Clinical Therapeutics - March 9, 2024 Category: Drugs & Pharmacology Authors: Rakesh Kantaria Karen Baker Senam Beckley-Kartey Ksenija Gorni Isabelle Montrocher-Ober Laurence Vindevoghel Source Type: research
Global Risdiplam Compassionate Use Program for Patients With Type 1 or 2 Spinal Muscular Atrophy
Clin Ther. 2024 Mar 8:S0149-2918(24)00061-4. doi: 10.1016/j.clinthera.2024.02.006. Online ahead of print.ABSTRACTPURPOSE: Spinal muscular atrophy (SMA) is a genetic neuromuscular disease causing progressive muscle weakness and reducing life expectancy. Risdiplam (Evrysdi; Genentech/F. Hoffmann-La Roche Ltd, Basel, Switzerland) is a drug approved for use in the treatment of patients with SMA. The ongoing global risdiplam Compassionate Use Program (CUP), initiated in November 2019, is the largest CUP in SMA, currently providing access to risdiplam for >2000 patients with type 1 or 2 SMA in 59 countries. Here, the challeng...
Source: Clinical Therapeutics - March 9, 2024 Category: Drugs & Pharmacology Authors: Rakesh Kantaria Karen Baker Senam Beckley-Kartey Ksenija Gorni Isabelle Montrocher-Ober Laurence Vindevoghel Source Type: research
Nirmatrelvir and ritonavir
Clin Ther. 2024 Mar 7:S0149-2918(24)00042-0. doi: 10.1016/j.clinthera.2024.02.004. Online ahead of print.NO ABSTRACTPMID:38458901 | DOI:10.1016/j.clinthera.2024.02.004 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - March 8, 2024 Category: Drugs & Pharmacology Authors: Paul Beninger Source Type: research
Attainment of Target in Therapeutic Range of International Normalized Ratio and Correlates Among Patients on Warfarin Therapy at Jimma Medical Center, Jimma, Ethiopia
This study aimed to assess the attainment of target therapeutic range, proportion, and factors associated with subtherapeutic level of warfarin.METHODS: A hospital-based cross-sectional study was conducted at Jimma Medical Center in Jimma, Ethiopia, from October 1, 2020 through December 30, 2021. All patients on warfarin and attending Medical Follow-Up Clinics of Jimma Medical Center during the study period were included. Data were collected using structured questionnaires and then analyzed using EpiData Manager software, version 3.1 (EpiData Association). χ2 Tests and logistic regression models were used to assess relati...
Source: Clinical Therapeutics - March 1, 2024 Category: Drugs & Pharmacology Authors: Abdulkadir Urgessa Jada Gashahun Mekonnen Disassa Belete Habte Melesse Mohammed Mecha Abafogi Eyob Girma Abera Kelil Hussein Jibicho Kedir Negesso Tukeni Source Type: research
Attainment of Target in Therapeutic Range of International Normalized Ratio and Correlates Among Patients on Warfarin Therapy at Jimma Medical Center, Jimma, Ethiopia
This study aimed to assess the attainment of target therapeutic range, proportion, and factors associated with subtherapeutic level of warfarin.METHODS: A hospital-based cross-sectional study was conducted at Jimma Medical Center in Jimma, Ethiopia, from October 1, 2020 through December 30, 2021. All patients on warfarin and attending Medical Follow-Up Clinics of Jimma Medical Center during the study period were included. Data were collected using structured questionnaires and then analyzed using EpiData Manager software, version 3.1 (EpiData Association). χ2 Tests and logistic regression models were used to assess relati...
Source: Clinical Therapeutics - March 1, 2024 Category: Drugs & Pharmacology Authors: Abdulkadir Urgessa Jada Gashahun Mekonnen Disassa Belete Habte Melesse Mohammed Mecha Abafogi Eyob Girma Abera Kelil Hussein Jibicho Kedir Negesso Tukeni Source Type: research
Attainment of Target in Therapeutic Range of International Normalized Ratio and Correlates Among Patients on Warfarin Therapy at Jimma Medical Center, Jimma, Ethiopia
This study aimed to assess the attainment of target therapeutic range, proportion, and factors associated with subtherapeutic level of warfarin.METHODS: A hospital-based cross-sectional study was conducted at Jimma Medical Center in Jimma, Ethiopia, from October 1, 2020 through December 30, 2021. All patients on warfarin and attending Medical Follow-Up Clinics of Jimma Medical Center during the study period were included. Data were collected using structured questionnaires and then analyzed using EpiData Manager software, version 3.1 (EpiData Association). χ2 Tests and logistic regression models were used to assess relati...
Source: Clinical Therapeutics - March 1, 2024 Category: Drugs & Pharmacology Authors: Abdulkadir Urgessa Jada Gashahun Mekonnen Disassa Belete Habte Melesse Mohammed Mecha Abafogi Eyob Girma Abera Kelil Hussein Jibicho Kedir Negesso Tukeni Source Type: research
Attainment of Target in Therapeutic Range of International Normalized Ratio and Correlates Among Patients on Warfarin Therapy at Jimma Medical Center, Jimma, Ethiopia
This study aimed to assess the attainment of target therapeutic range, proportion, and factors associated with subtherapeutic level of warfarin.METHODS: A hospital-based cross-sectional study was conducted at Jimma Medical Center in Jimma, Ethiopia, from October 1, 2020 through December 30, 2021. All patients on warfarin and attending Medical Follow-Up Clinics of Jimma Medical Center during the study period were included. Data were collected using structured questionnaires and then analyzed using EpiData Manager software, version 3.1 (EpiData Association). χ2 Tests and logistic regression models were used to assess relati...
Source: Clinical Therapeutics - March 1, 2024 Category: Drugs & Pharmacology Authors: Abdulkadir Urgessa Jada Gashahun Mekonnen Disassa Belete Habte Melesse Mohammed Mecha Abafogi Eyob Girma Abera Kelil Hussein Jibicho Kedir Negesso Tukeni Source Type: research
Attainment of Target in Therapeutic Range of International Normalized Ratio and Correlates Among Patients on Warfarin Therapy at Jimma Medical Center, Jimma, Ethiopia
This study aimed to assess the attainment of target therapeutic range, proportion, and factors associated with subtherapeutic level of warfarin.METHODS: A hospital-based cross-sectional study was conducted at Jimma Medical Center in Jimma, Ethiopia, from October 1, 2020 through December 30, 2021. All patients on warfarin and attending Medical Follow-Up Clinics of Jimma Medical Center during the study period were included. Data were collected using structured questionnaires and then analyzed using EpiData Manager software, version 3.1 (EpiData Association). χ2 Tests and logistic regression models were used to assess relati...
Source: Clinical Therapeutics - March 1, 2024 Category: Drugs & Pharmacology Authors: Abdulkadir Urgessa Jada Gashahun Mekonnen Disassa Belete Habte Melesse Mohammed Mecha Abafogi Eyob Girma Abera Kelil Hussein Jibicho Kedir Negesso Tukeni Source Type: research
Attainment of Target in Therapeutic Range of International Normalized Ratio and Correlates Among Patients on Warfarin Therapy at Jimma Medical Center, Jimma, Ethiopia
This study aimed to assess the attainment of target therapeutic range, proportion, and factors associated with subtherapeutic level of warfarin.METHODS: A hospital-based cross-sectional study was conducted at Jimma Medical Center in Jimma, Ethiopia, from October 1, 2020 through December 30, 2021. All patients on warfarin and attending Medical Follow-Up Clinics of Jimma Medical Center during the study period were included. Data were collected using structured questionnaires and then analyzed using EpiData Manager software, version 3.1 (EpiData Association). χ2 Tests and logistic regression models were used to assess relati...
Source: Clinical Therapeutics - March 1, 2024 Category: Drugs & Pharmacology Authors: Abdulkadir Urgessa Jada Gashahun Mekonnen Disassa Belete Habte Melesse Mohammed Mecha Abafogi Eyob Girma Abera Kelil Hussein Jibicho Kedir Negesso Tukeni Source Type: research
