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View article: Safety, Pharmacokinetics, and Pharmacodynamics of Osivelotor for Sickle Cell Disease: First‐in‐Human Studies in Healthy Participants and Patients
Safety, Pharmacokinetics, and Pharmacodynamics of Osivelotor for Sickle Cell Disease: First‐in‐Human Studies in Healthy Participants and Patients Open
The investigational agent osivelotor, a small molecule hemoglobin (Hb) modifier in development for the treatment of sickle cell disease (SCD), acts by increasing Hb‐oxygen affinity and inhibiting the polymerization of sickle Hb. We report …
View article: Clinical assessment of gepotidacin (<scp>GSK2140944</scp>) as a victim and perpetrator of <scp>drug–drug</scp> interactions via <scp>CYP3A</scp> metabolism and transporters
Clinical assessment of gepotidacin (<span>GSK2140944</span>) as a victim and perpetrator of <span>drug–drug</span> interactions via <span>CYP3A</span> metabolism and transporters Open
Gepotidacin is a novel triazaacenaphthylene antibiotic in phase III development. Based on nonclinical in vitro characterization of gepotidacin metabolism, two phase I studies were conducted in healthy participants to investigate clinical d…
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AGORA, and OARE initiatives.They are now collectively known as Research4Life
View article: Pharmacokinetic, Safety, and Tolerability Evaluations of Gepotidacin (GSK2140944) in Healthy Japanese Participants
Pharmacokinetic, Safety, and Tolerability Evaluations of Gepotidacin (GSK2140944) in Healthy Japanese Participants Open
Gepotidacin is a novel, bactericidal, first‐in‐class triazaacenaphthylene antibiotic in late‐phase development for uncomplicated urinary tract infection and uncomplicated urogenital gonorrhea. Two clinical studies were conducted to assess …
View article: S268: SAFETY, TOLERABILITY, AND PHARMACOKINETIC/PHARMACODYNAMIC RESULTS FROM PHASE 1 STUDIES OF GBT021601, A NEXT-GENERATION HBS POLYMERIZATION INHIBITOR FOR TREATMENT OF SICKLE CELL DISEASE
S268: SAFETY, TOLERABILITY, AND PHARMACOKINETIC/PHARMACODYNAMIC RESULTS FROM PHASE 1 STUDIES OF GBT021601, A NEXT-GENERATION HBS POLYMERIZATION INHIBITOR FOR TREATMENT OF SICKLE CELL DISEASE Open
Background: Sickle cell disease (SCD) is caused by polymerization of sickle hemoglobin (HbS). Voxelotor is a first-in-class HbS polymerization inhibitor approved by the United States Food and Drug Administration for the treatment of SCD in…
View article: 1115. Evaluation of Gepotidacin (GSK2140944) Pharmacokinetics and Food Effect in Japanese Subjects
1115. Evaluation of Gepotidacin (GSK2140944) Pharmacokinetics and Food Effect in Japanese Subjects Open
Background Gepotidacin, a novel, first-in-class triazaacenaphthylene antibiotic, inhibits bacterial replication and has in vitro and in vivo activity against key pathogens, including drug-resistant strains, associated with a range of infec…
View article: Pharmacokinetics of Oral Formulations of Gepotidacin (GSK2140944), a Triazaacenaphthylene Bacterial Type II Topoisomerase Inhibitor, in Healthy Adult and Adolescent Participants
Pharmacokinetics of Oral Formulations of Gepotidacin (GSK2140944), a Triazaacenaphthylene Bacterial Type II Topoisomerase Inhibitor, in Healthy Adult and Adolescent Participants Open
Gepotidacin is a novel, first-in-class triazaacenaphthylene antibiotic that may provide a new treatment option for antibiotic-resistant pathogens. Two pharmacokinetic evaluations of oral gepotidacin are presented: a relative bioavailabilit…
View article: Comparison between physiologically based pharmacokinetic and population pharmacokinetic modelling to select paediatric doses of gepotidacin in plague
Comparison between physiologically based pharmacokinetic and population pharmacokinetic modelling to select paediatric doses of gepotidacin in plague Open
Aims To develop physiologically based pharmacokinetic (PBPK) and population pharmacokinetic (PopPK) models to predict effective doses of gepotidacin in paediatrics for the treatment of pneumonic plague ( Yersinia pestis ). Methods A gepoti…
View article: Pharmacokinetics of Gepotidacin in Subjects With Normal Hepatic Function and Hepatic Impairment
Pharmacokinetics of Gepotidacin in Subjects With Normal Hepatic Function and Hepatic Impairment Open
Gepotidacin is a novel triazaacenaphthylene bacterial topoisomerase inhibitor. This phase 1 nonrandomized, open‐label, multicenter, 2‐part study evaluated the pharmacokinetics, safety, and tolerability of oral gepotidacin 1500 mg in 3 diff…
View article: Phase 2a Pharmacokinetic, Safety, and Exploratory Efficacy Evaluation of Oral Gepotidacin (GSK2140944) in Female Participants with Uncomplicated Urinary Tract Infection (Acute Uncomplicated Cystitis)
Phase 2a Pharmacokinetic, Safety, and Exploratory Efficacy Evaluation of Oral Gepotidacin (GSK2140944) in Female Participants with Uncomplicated Urinary Tract Infection (Acute Uncomplicated Cystitis) Open
Gepotidacin, a triazaacenaphthylene bacterial type II topoisomerase inhibitor, is in development for treatment of uncomplicated urinary tract infection (uUTI). This phase 2a study in female participants with uUTI evaluated the pharmacokine…
View article: Population Pharmacokinetic/Pharmacodynamic Analysis of Intravenous Zanamivir in Healthy Adults and Hospitalized Adult and Pediatric Subjects With Influenza
Population Pharmacokinetic/Pharmacodynamic Analysis of Intravenous Zanamivir in Healthy Adults and Hospitalized Adult and Pediatric Subjects With Influenza Open
Zanamivir is a potent and highly selective inhibitor of influenza neuraminidase in which the inhibition of this enzyme prevents the virus from infecting other cells and specifically prevents release of the new virion from the host cell mem…
View article: 1560. Pharmacokinetics–Pharmacodynamics (PK-PD) of Gepotidacin (GEP) Against Escherichia coli in Murine Pyelonephritis and Thigh Infection Models
1560. Pharmacokinetics–Pharmacodynamics (PK-PD) of Gepotidacin (GEP) Against Escherichia coli in Murine Pyelonephritis and Thigh Infection Models Open
Background GEP, a first in class novel triazaacenaphthylene bacterial topoisomerase inhibitor, inhibits bacterial replication and has in vitro activity against key pathogens implicated in a range of infections, including drug-resistant str…
View article: Simultaneous liquid chromatography- tandem mass spectrometry method to quantify epicatechin and procyanidin B2 in rat plasma after oral administration of Trichilia catigua (catuaba) extract and its application to a pharmacokinetic study
Simultaneous liquid chromatography- tandem mass spectrometry method to quantify epicatechin and procyanidin B2 in rat plasma after oral administration of Trichilia catigua (catuaba) extract and its application to a pharmacokinetic study Open
Trichilia catigua A. Juss., Meliaceae, known as catuaba in Brazil, is traditionally used for the treatment of stress, sexual impotence and memory deficits. To our knowledge, there is no analytical method described in literature for simulta…
View article: Cavitary Penetration of Levofloxacin among Patients with Multidrug-Resistant Tuberculosis
Cavitary Penetration of Levofloxacin among Patients with Multidrug-Resistant Tuberculosis Open
A better understanding of second-line drug (SLD) pharmacokinetics, including cavitary penetration, may help optimize SLD dosing. Patients with pulmonary multidrug-resistant tuberculosis (MDR-TB) undergoing adjunctive surgery were enrolled …