Ramesh Boinpally
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View article: Exposure–Response Modeling of Monthly Migraine Days for Efficacy of Atogepant in Patients With Episodic or Chronic Migraine
Exposure–Response Modeling of Monthly Migraine Days for Efficacy of Atogepant in Patients With Episodic or Chronic Migraine Open
This work aimed to develop an appropriate model to evaluate the exposure–response relationship (ERR) for monthly migraine days (MMD) in atogepant's key migraine prevention clinical trials to support dose selection. The ERR between atogepan…
View article: Mass Balance and Metabolism of <scp> <sup>14</sup> C </scp> ‐Atogepant in Healthy Male Participants: Findings of a Phase 1 Clinical Trial
Mass Balance and Metabolism of <span> <sup>14</sup> C </span> ‐Atogepant in Healthy Male Participants: Findings of a Phase 1 Clinical Trial Open
Atogepant, a calcitonin gene‐related peptide (CGRP) receptor antagonist, is approved for the preventive treatment of migraine in adults. This open‐label, phase 1 study examined radiolabeled atogepant ( 14 C‐atogepant) metabolism, eliminati…
View article: Pharmacokinetics of Atogepant in Healthy Lactating Female Participants: Results from a Phase 1 Lactation Study
Pharmacokinetics of Atogepant in Healthy Lactating Female Participants: Results from a Phase 1 Lactation Study Open
The cumulative mean amount of atogepant recovered in breast milk over 24 h following a 60-mg dose was 0.009 mg, with a RID of 0.19%. CLINICAL TRIAL REGISTRATION: NCT05892757; https://clinicaltrials.gov/study/NCT05892757 .
View article: Milk and plasma pharmacokinetics of single‐dose ubrogepant in healthy lactating women
Milk and plasma pharmacokinetics of single‐dose ubrogepant in healthy lactating women Open
Objective The objectives of this study were to evaluate the safety, plasma and milk pharmacokinetics, excretion in breast milk, and the relative infant dose of ubrogepant following a single oral dose. Background Ubrogepant is a calcitonin …
View article: A 2‐Part, Open‐Label, Phase 1 Bioequivalence and Food‐Effect Study of Ubrogepant in Healthy Adult Participants
A 2‐Part, Open‐Label, Phase 1 Bioequivalence and Food‐Effect Study of Ubrogepant in Healthy Adult Participants Open
This Phase 1 study of ubrogepant was conducted to establish the bioequivalence (BE) of the 50‐ and 100‐mg to‐be‐marketed (TBM) tablet formulations with the clinical trial (CT) 100‐mg tablet formulation and evaluate the food effect on the b…
View article: Clinical Pharmacokinetics of Atogepant in Healthy Japanese and White Adults
Clinical Pharmacokinetics of Atogepant in Healthy Japanese and White Adults Open
View article: Effect of a High‐Fat Meal on the Pharmacokinetics of an Immediate Release Atogepant Tablet
Effect of a High‐Fat Meal on the Pharmacokinetics of an Immediate Release Atogepant Tablet Open
Atogepant, an oral calcitonin gene‐related peptide receptor antagonist, is approved for the preventive treatment of migraine. A phase 1, open‐label, single‐dose, 2‐period crossover study evaluated the effect of a high‐fat meal on the pharm…
View article: Pharmacokinetics and Safety of Atogepant Co‐administered with Quinidine Gluconate in Healthy Participants: A Phase 1, Open‐Label, Drug‐Drug Interaction Study
Pharmacokinetics and Safety of Atogepant Co‐administered with Quinidine Gluconate in Healthy Participants: A Phase 1, Open‐Label, Drug‐Drug Interaction Study Open
Atogepant, an oral calcitonin gene‐related peptide receptor antagonist, is approved for the preventive treatment of migraine. Atogepant is a substrate of P‐glycoprotein (P‐gp), breast cancer resistance protein, organic anion transporting p…
View article: Pharmacokinetics of Ubrogepant in Healthy Japanese and White Adults
Pharmacokinetics of Ubrogepant in Healthy Japanese and White Adults Open
Ubrogepant is a calcitonin gene‐related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults. The objectives of this study were to evaluate (1) single‐dose pharmacokinetics (PK) and dose …
View article: Atogepant: Mechanism of action, clinical and translational science
Atogepant: Mechanism of action, clinical and translational science Open
Since the discovery of calcitonin gene‐related peptide (CGRP) in 1982, its integral role in migraine pathophysiology, specifically migraine pain, has been demonstrated through cumulative scientific discoveries that have led to the developm…
View article: Ubrogepant: Mechanism of action, clinical and translational science
Ubrogepant: Mechanism of action, clinical and translational science Open
In recent years, the treatment of migraine has experienced a breakthrough in the development of drugs that target the calcitonin gene‐related peptide (CGRP) signaling pathway. Monoclonal antibodies against the receptor or ligand have been …
View article: Effects of CYP3A4 Inhibition/Induction and OATP Inhibition on the Pharmacokinetics of Atogepant in Healthy Adults
Effects of CYP3A4 Inhibition/Induction and OATP Inhibition on the Pharmacokinetics of Atogepant in Healthy Adults Open
Aim: Atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, is a substrate of OATP and metabolized by CYP3A4. Effect of multiple-dose itraconazole (strong CYP3A4 inhibitor), single-dose rifampin (strong OATP inhibi…
View article: Pharmacokinetics and Safety of Coadministered Atogepant and Topiramate in Healthy Participants: A Phase 1, Open‐Label, Drug–Drug Interaction Study
Pharmacokinetics and Safety of Coadministered Atogepant and Topiramate in Healthy Participants: A Phase 1, Open‐Label, Drug–Drug Interaction Study Open
Atogepant, an oral calcitonin gene‐related peptide receptor antagonist, and topiramate, a commonly used oral antiepileptic, are approved as preventive migraine treatments. Given the distinct mechanisms of action of these treatments, it is …
View article: Supplementary Figure Legend from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies
Supplementary Figure Legend from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies Open
PDF file - 41K
View article: Data from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies
Data from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies Open
Purpose: OSI-930 is a novel, potent, oral small-molecule receptor tyrosine kinase inhibitor, predominantly against VEGF receptors (VEGFR), c-Kit, and platelet-derived growth factor receptors. A phase I trial was undertaken to determ…
View article: Supplementary Table 2 from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies
Supplementary Table 2 from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies Open
PDF file - 72K, The semi-quantitative DCE-MRI endpoints for assessment of tumor perfusion (IAUC) and overall tumor vascularity (AUC)
View article: Supplementary Table 1 from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies
Supplementary Table 1 from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies Open
PDF file - 56K, FDG-PET Responses
View article: Supplementary Methods from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies
Supplementary Methods from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies Open
PDF file - 86K
View article: Supplementary Figure 3 from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies
Supplementary Figure 3 from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies Open
PDF file - 47K, Association of sVEGR2 changes at the end of the first dosing cycle and patient response in the 500mg BID expansion cohort
View article: Supplementary Table 1 from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies
Supplementary Table 1 from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies Open
PDF file - 56K, FDG-PET Responses
View article: Supplementary Figure 1 from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies
Supplementary Figure 1 from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies Open
PDF file - 58K, Changes in plasma sVEGFR2 over time in BID cohorts
View article: Data from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies
Data from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies Open
Purpose: OSI-930 is a novel, potent, oral small-molecule receptor tyrosine kinase inhibitor, predominantly against VEGF receptors (VEGFR), c-Kit, and platelet-derived growth factor receptors. A phase I trial was undertaken to determ…
View article: Supplementary Figure 1 from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies
Supplementary Figure 1 from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies Open
PDF file - 58K, Changes in plasma sVEGFR2 over time in BID cohorts
View article: Supplementary Figure 3 from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies
Supplementary Figure 3 from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies Open
PDF file - 47K, Association of sVEGR2 changes at the end of the first dosing cycle and patient response in the 500mg BID expansion cohort
View article: Supplementary Table 2 from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies
Supplementary Table 2 from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies Open
PDF file - 72K, The semi-quantitative DCE-MRI endpoints for assessment of tumor perfusion (IAUC) and overall tumor vascularity (AUC)
View article: Supplementary Figure 2 from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies
Supplementary Figure 2 from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies Open
PDF file - 39K, Association of sVEGFR2 changes and steady state OSI-930 levels at the end of the first 21-day dosing cycle in the 500mg BID expansion cohort
View article: Supplementary Figure 2 from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies
Supplementary Figure 2 from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies Open
PDF file - 39K, Association of sVEGFR2 changes and steady state OSI-930 levels at the end of the first 21-day dosing cycle in the 500mg BID expansion cohort
View article: Supplementary Methods from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies
Supplementary Methods from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies Open
PDF file - 86K
View article: Supplementary Figure Legend from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies
Supplementary Figure Legend from First-in-Human Phase I Trial of Two Schedules of OSI-930, a Novel Multikinase Inhibitor, Incorporating Translational Proof-of-Mechanism Studies Open
PDF file - 41K
View article: Phase Ib, open‐label, fixed‐sequence, drug–drug interaction, safety, and tolerability study between atogepant and ubrogepant in participants with a history of migraine
Phase Ib, open‐label, fixed‐sequence, drug–drug interaction, safety, and tolerability study between atogepant and ubrogepant in participants with a history of migraine Open
Objective To evaluate potential drug–drug interactions of ubrogepant and atogepant. Background Ubrogepant and atogepant, calcitonin gene‐related peptide (CGRP) receptor antagonists, are recently approved drugs for acute and preventive trea…