Cargando…

Confirmation of the cardiac safety of nolasiban in a randomised cohort of healthy female volunteers

Nolasiban is an orally active oxytocin receptor antagonist being developed to increase the efficiency of assisted reproductive technologies. This study evaluated the pharmacokinetics, pharmacodynamics, and cardiac safety of nolasiban in 45 healthy women of child-bearing age. Nolasiban was administer...

Descripción completa

Detalles Bibliográficos
Autores principales:	Täubel, Jörg, Lorch, Ulrike, Spencer, Christopher S., Freier, Anne, Camilleri, Dorothée, Djumanov, Dilshat, Ferber, Georg, Marchand, Line, Gotteland, Jean-Pierre, Pohl, Oliver
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Nature Publishing Group UK 2021
Materias:	Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7973531/ https://www.ncbi.nlm.nih.gov/pubmed/33739022 http://dx.doi.org/10.1038/s41598-021-85650-3

Ejemplares similares

Kinetics of anti-SARS-CoV-2 IgG antibody levels and potential influential factors in subjects with COVID-19: A 11-month follow-up study
por: Luo, Huanyuan, et al.
Publicado: (2021)

Time- and Race-Specific Haematological Reference Intervals for Healthy Volunteer Trials: A Retrospective Analysis of Pooled Data From Multiple Phase I Trials
por: Coates, Simon, et al.
Publicado: (2020)

Confirmation of the Cardiac Safety of PGF(2α) Receptor Antagonist OBE022 in a First‐in‐Human Study in Healthy Subjects, Using Intensive ECG Assessments
por: Täubel, Jörg, et al.
Publicado: (2018)

Safety, Tolerability, and Dose Proportionality of a Novel Transdermal Fentanyl Matrix Patch and Bioequivalence With a Matrix Fentanyl Patch: Two Phase 1 Single‐Center Open‐Label, Randomized Crossover Studies in Healthy Japanese Volunteers
por: Lorch, Ulrike, et al.
Publicado: (2020)

Concentration‐QT modelling of the novel DHFR inhibitor P218 in healthy male volunteers
por: Täubel, Jӧrg, et al.
Publicado: (2021)

The Power of Phase I Studies to Detect Clinical Relevant QTc Prolongation: A Resampling Simulation Study
por: Ferber, Georg, et al.
Publicado: (2015)

Differential Effects of Oxytocin Receptor Antagonists, Atosiban and Nolasiban, on Oxytocin Receptor–Mediated Signaling in Human Amnion and Myometrium
por: Kim, Sung Hye, et al.
Publicado: (2017)

Pharmacokinetics, Safety and Cognitive Function Profile of Rupatadine 10, 20 and 40 mg in Healthy Japanese Subjects: A Randomised Placebo-Controlled Trial
por: Täubel, Jörg, et al.
Publicado: (2016)

Oxytocin Receptor Antagonists, Atosiban and Nolasiban, Inhibit Prostaglandin F(2α)-induced Contractions and Inflammatory Responses in Human Myometrium
por: Kim, Sung Hye, et al.
Publicado: (2019)

The Cardiovascular Effects of a Meal: J‐T(peak) and T(peak)‐T(end) Assessment and Further Insights Into the Physiological Effects
por: Täubel, Jörg, et al.
Publicado: (2019)

Comparing the consistency of electrocardiogram interval measurements by resting ECG versus 12‐lead Holter
por: Mendzelevski, Boaz, et al.
Publicado: (2021)

Single Doses up to 800 mg of E-52862 Do Not Prolong the QTc Interval – A Retrospective Validation by Pharmacokinetic-Pharmacodynamic Modelling of Electrocardiography Data Utilising the Effects of a Meal on QTc to Demonstrate ECG Assay Sensitivity
por: Täubel, Jörg, et al.
Publicado: (2015)

Thorough QT study of the effect of intravenous amisulpride on QTc interval in Caucasian and Japanese healthy subjects
por: Täubel, Jörg, et al.
Publicado: (2016)

Effects of the Fluoroquinolones Moxifloxacin and Levofloxacin on the QT Subintervals: Sex Differences in Ventricular Repolarization
por: Täubel, Jӧrg, et al.
Publicado: (2019)

Blinding Is Seeing: A Single-Centre Study Into the Viability of Auto-Injectors for Blinded-Drug Administration in Randomised Controlled Trials
por: Aggarwal, Vishal, et al.
Publicado: (2023)

Three steps to writing adaptive study protocols in the early phase clinical development of new medicines
por: Lorch, Ulrike, et al.
Publicado: (2014)

Estimation of the Power of the Food Effect on QTc to Show Assay Sensitivity
por: Ferber, Georg, et al.
Publicado: (2017)

A Phase 1 Study to Investigate the Effects of Cortexolone 17α‐Propionate, Also Known as Clascoterone, on the QT Interval Using the Meal Effect to Demonstrate ECG Assay Sensitivity
por: Täubel, Jörg, et al.
Publicado: (2021)

The Reliability of Auto-Injectors in Clinical Use: A Systematic Review
por: Dostal, Petr, et al.
Publicado: (2023)

Time of the Day and Magnitude of the Effect of a Drug on the QTc Interval
por: Täubel, J, et al.
Publicado: (2017)

Association for Human Pharmacology in the Pharmaceutical Industry conference 2022: impending change, innovations and future challenges
por: Mundy, Charles, et al.
Publicado: (2023)

Pharmacokinetics of concentrated naloxone nasal spray for opioid overdose reversal: Phase I healthy volunteer study
por: McDonald, Rebecca, et al.
Publicado: (2017)

The Association for Human Pharmacology in the Pharmaceutical Industry London Meeting October 2019: Impending Change, Innovation, and Future Challenges
por: Khan, Shahzadgai, et al.
Publicado: (2020)

Safety, Tolerability, Pharmacokinetics, and Antimalarial Activity of the Novel Plasmodium Phosphatidylinositol 4-Kinase Inhibitor MMV390048 in Healthy Volunteers
por: Sinxadi, Phumla, et al.
Publicado: (2020)

The Association for Human Pharmacology in the Pharmaceutical Industry London Meeting 2018: Brexit and Other Challenges in Early Phase Drug Development
por: Reijntjes, Susan, et al.
Publicado: (2018)

Confirmed Cases of Ophidiomycosis in Museum Specimens from as Early as 1945, United States
por: Lorch, Jeffrey M., et al.
Publicado: (2021)

Confirmation of Biosimilarity in a Pharmacokinetic/Pharmacodynamic Study in Healthy Volunteers for an Analytically Highly Similar Pegfilgrastim
por: Desai, Kalpna, et al.
Publicado: (2016)

A Dose‐Confirmation Phase 1 Study to Evaluate the Safety and Pharmacology of Glucarpidase in Healthy Volunteers
por: Fukaya, Yutaka, et al.
Publicado: (2021)

Women's Volunteering and Voluntary Leadership Positions in Sport—Secondary Analyses of the German Survey on Volunteering
por: Burrmann, Ulrike, et al.
Publicado: (2022)

Modulation of Postprandial Plasma Concentrations of Digestive Hormones and Gut Microbiota by Foods Containing Oat ß-Glucans in Healthy Volunteers
por: Gotteland, Martin, et al.
Publicado: (2023)

Novel antisense therapy targeting microRNA-132 in patients with heart failure: results of a first-in-human Phase 1b randomized, double-blind, placebo-controlled study
por: Täubel, Jörg, et al.
Publicado: (2020)

Volunteers or victims: patients' views of randomised cancer clinical trials.
por: Slevin, M., et al.
Publicado: (1995)

Impact of Dietary Lipids on Colonic Function and Microbiota: An Experimental Approach Involving Orlistat-Induced Fat Malabsorption in Human Volunteers
por: Morales, Pamela, et al.
Publicado: (2016)

A model‐based analysis to guide gonadotropin‐releasing hormone receptor antagonist use for management of endometriosis
por: Pohl, Oliver, et al.
Publicado: (2022)

Effect of hyperglycaemia in combination with moxifloxacin on cardiac repolarization in male and female patients with type I diabetes
por: Taubel, Jorg, et al.
Publicado: (2022)

Changes in joint coupling and variability during walking following tibialis posterior muscle fatigue
por: Ferber, Reed, et al.
Publicado: (2011)

Endocannabinergic modulation of central serotonergic activity in healthy human volunteers
por: Emons, Barbara, et al.
Publicado: (2023)

Effectiveness of a volunteer befriending programme for patients with schizophrenia: randomised controlled trial
por: Priebe, Stefan, et al.
Publicado: (2020)

Development of an Innovative Berberine Food-Grade Formulation with an Ameliorated Absorption: In Vitro Evidence Confirmed by Healthy Human Volunteers Pharmacokinetic Study
por: Petrangolini, Giovanna, et al.
Publicado: (2021)

The Dutch Comparative Scale for Assessing Volunteer Motivations among Volunteers and Non-Volunteers: An Adaptation of the Volunteer Functions Inventory
por: Niebuur, Jacobien, et al.
Publicado: (2019)

Cannot write session to /tmp/vufind_sessions/sess_r9dt2275j6nt0e0i6tlclhke0p