Safety, Tolerability, and Pharmacokinetics of Eliglustat Tartrate (Genz‐112638) After Single Doses, Multiple Doses, and Food in Healthy Volunteers
- M. Peterschmitt, A. Burke, P. Bonate
- Medicine, BiologyJournal of clinical pharmacology
- 1 May 2011
Eliglustat tartrate was well tolerated at single doses ≤20 mg/kg and multiple doses ≤200 mg bid, with 50 mg bid producing plasma concentrations in the predicted therapeutic range, and a phase 2 trial of eliglustat Tartrate was initiated in GD1 patients.
Exploratory study on the reversal of warfarin with rFVIIa in healthy subjects.
- B. Skolnick, D. Mathews, N. Khutoryansky, A. Pusateri, M. Carr
- MedicineBlood
- 5 August 2010
In this exploratory trial, the reversal of warfarin effects was observed in the thromboelastography, thrombin generation, and clotting assays, but this reversal did not translate to improvements in the bleeding model parameters evaluated in the punch biopsy model.
Pharmacokinetic Evaluations of the Co-Administrations of Vandetanib and Metformin, Digoxin, Midazolam, Omeprazole or Ranitidine
- S. Johansson, J. Read, P. Martin
- Medicine, BiologyClinical Pharmacokinetics
- 26 September 2014
Vandetanib with CYP3A4 substrates or omeprazole/ranitidine is unlikely to result in clinically relevant drug–drug interactions, but may require additional monitoring of metformin/digoxin, with dose adjustments where necessary.
A Phase 1, First-in-Man, Dose-Response Study of Aes-103 (5-HMF), an Anti-Sickling, Allosteric Modifier of Hemoglobin Oxygen Affinity in Healthy Norman Volunteers
- W. Stern, D. Mathews, J. McKew, Xi-zhong Shen, G. Kato
- Medicine
- 16 November 2012
The pharmacokinetic profile of 5-HMF in plasma showed dose-proportional kinetics with an upward trend towards higher Cmax and AUC at higher doses, and results showed an appreciable attenuation of the drop in SpO2 values due to hypoxia.
Effects of cytochrome P450 (CYP3A4 and CYP2C19) inhibition and induction on the exposure of selumetinib, a MEK1/2 inhibitor, in healthy subjects: results from two clinical trials
- A. Dymond, Karen So, G. Mariani
- Medicine, BiologyEuropean Journal of Clinical Pharmacology
- 26 November 2016
Co-administration of CYP3A4/CYP2C19 inhibitors will likely increase exposure to selumetinib, while CYP 3A4 inducers will likely reduce its exposure.
Effects of Fostamatinib on the Pharmacokinetics of Oral Contraceptive, Warfarin, and the Statins Rosuvastatin and Simvastatin: Results From Phase I Clinical Studies
Fostamatinib exhibits drug–drug interactions when co-administered with OC, simvastatin, or rosuvASTatin, with the AUC of statins almost doubling, and did not exhibit a clinically relevant DDI on warfarin.
Effects of ranitidine (antacid), food, and formulation on the pharmacokinetics of fostamatinib: results from five phase I clinical studies
- T. Flanagan, P. Martin, M. Gillen, D. Mathews, E. Lisbon, Martin Kruusmägi
- Chemistry, BiologyEuropean Journal of Clinical Pharmacology
- 1 February 2017
The in vivo performance of fostamatinib was generally insensitive to changes in in vitro dissolution performance, although marked slowing of the dissolution rate did impact exposures.
Ex-Vivo Assessments in the Evaluation of Dose Response to Recombinant Factor VIIa When Administered for Bleeding Following Punch Biopsies in Healthy Volunteers.
- D. Gabriel, B. Skolnick, P. Leese, D. Mathews
- Medicine
- 16 November 2005
In this model system, designed to evaluate hemostasis, interesting effects were seen with the HHA instrument which suggest that increasing doses of rFVIIa may impact clot stability, but these observations are limited by the significant hetereogeneity.
Effect of Recombinant Activated Factor VII (rFVIIa) on Platelet and Clotting Systems in Healthy Volunteers.
- D. Gabriel, B. Skolnick, S. Seremetis, P. Leese, D. Mathews
- Medicine
- 16 November 2005
Results indicate that overall there was a trend towards an increase in platelet contractile force and clot elastic modulus with an apparent maximal effect at 1 hour post-biopsy, which implies that the administration of rFVIIa may have an effect in non-coagulopathic individuals.
Randomized, placebo‐controlled study to assess the impact on QT/QTc interval of supratherapeutic doses of ceftazidime–avibactam or ceftaroline fosamil–avibactam
- Shampa Das, J. Armstrong, D. Mathews, Jianguo Li, T. Edeki
- Medicine, BiologyJournal of clinical pharmacology
- 1 March 2014
In conclusion, supratherapeutic doses of ceftaroline fosamil–avibactam or ceftazidime–avIBactam were not associated with QT/QTc prolongation in this study population.
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