Imperial College London
Alternate

DrDamienAshby

Faculty of Medicine, Department of Immunology and Inflammation

Honorary Senior Lecturer
 
 
 
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Contact

 

+44 (0)20 3313 2718d.ashby

 
 
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Location

 

Commonwealth BuildingHammersmith Campus

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Summary

 

Publications

Citation

BibTex format

@article{Tan:2012:10.1111/j.1365-2125.2011.04082.x,
author = {Tan, TM and Field, BCT and Minnion, JS and Cuenco, Shillito J and Chambers, ES and Zac-Varghese, S and Brindley, CJ and Mt-Isa, S and Fiorentino, F and Ashby, D and Ward, I and Ghatei, MA and Bloom, SR},
doi = {10.1111/j.1365-2125.2011.04082.x},
journal = {British Journal of Clinical Pharmacology},
pages = {232--239},
title = {Pharmacokinetics, adverse effects and tolerability of a novel analogue of human pancreatic polypeptide, PP 1420.},
url = {http://dx.doi.org/10.1111/j.1365-2125.2011.04082.x},
volume = {73},
year = {2012}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - AIMS: The objectives of this phase 1 study were to confirm the tolerability ofsingle ascending subcutaneous doses of PP 1420 in healthy subjects, to assess itsadverse effects and to investigate the drug's pharmacokinetics and doseproportionality.METHODS: This was a double-blind, placebo-controlled, randomized study. Therewere three dosing periods. Each subject (n= 12) was randomized to receive onedose of placebo and two ascending doses of PP 1420, given as a subcutaneousinjection. Blood samples were taken over 24 h to assess pharmacokinetics.Standard safety and laboratory data were collected. The primary endpoint was the tolerability of PP 1420. The secondary endpoint was exposure to PP 1420 asassessed by C(max) and AUC(0,∞).RESULTS: PP 1420 was well tolerated by all subjects with no serious adverseeffects. Following single subcutaneous doses of PP 1420 at 2, 4 and 8 mg to male subjects, C(max) was reached at a median t(max) of approximately 1 h post dose(range 0.32-2.00 h). Thereafter, plasma concentrations of PP 1420 declined withgeometric mean apparent terminal elimination t(1/2) ranging from 2.42-2.61 h(range 1.64-3.95 h) across all dose levels.CONCLUSIONS: Subcutaneous PP 1420 was well tolerated in healthy human subjects atsingle doses between 2-8 mg, with no tolerability issues arising. Where observed,adverse events were not serious, and there was no evidence of a dose-relationshipto frequency of adverse events. The results therefore support the conduct ofclinical trials to investigate efficacy, tolerability and pharmacokinetics duringrepeated dosing.
AU  - Tan,TM
AU  - Field,BCT
AU  - Minnion,JS
AU  - Cuenco,Shillito J
AU  - Chambers,ES
AU  - Zac-Varghese,S
AU  - Brindley,CJ
AU  - Mt-Isa,S
AU  - Fiorentino,F
AU  - Ashby,D
AU  - Ward,I
AU  - Ghatei,MA
AU  - Bloom,SR
DO  - 10.1111/j.1365-2125.2011.04082.x
EP  - 239
PY  - 2012///
SP  - 232
TI  - Pharmacokinetics, adverse effects and tolerability of a novel analogue of human pancreatic polypeptide, PP 1420.
T2  - British Journal of Clinical Pharmacology
UR  - http://dx.doi.org/10.1111/j.1365-2125.2011.04082.x
VL  - 73
ER  -
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