First administration into man or UR-9825: A new triazole class of antifungal agent

Ref ID: 3700

Author:

Izquierdo, I., C Lurigados, I Perez, E Turmo, J Ramis.

Full conference title:

6th Congress of the European Confederation of Medical Mycology Societies

Abstract:

Ur-9825 is a new triazole class, with a potent broad espectrum antifungal
activity. It is expected to be effective in treating patients suffering from
all of the key opportunistic fungal infections including aspergillosis.
A first-time-in-man, phase I, double-blind, randomised, placebo controlled,
single rising dose study was conducted to evaluate the safety and
pharmacokinetic profile of unchanged UR-9825. Seventy-two healthy
volunteers were consecutively enrolled in-groups of 8 and randomly
assigned to receive UR-9825 or placebo. The following dose levels were
studied: 5, 10, 20, 40, 80, 160, 240, 320 and 400 mg. All subjects gave
their informed consent, and the study was approved by the Regional
Ethical Committee.
Ur-9825 was very well tolerated at all dose levels an no serious adverse
effects were reported. Furthermore, no clinical significant trends in
safety parameters were noted in vital signs, ECGS and labatory tests,
UR-9825 is rapidly absorbed reaching Cmax values at 2-4 h and widely
distributed throughout bodyfluids and the apparent Vd/f is about 5 L/kg.
There is a wide inter-subject variability in the elemination parameters of
UR-9825. The absorption rate (Cmax) and extension (AUC) of UR-9825
was dose proportional for lower-medium doses (5 to 80 mg), with a
range of mean terminal half-life between 30 h and 56h. A non-liniar
pharmacokinetics trend at higher doses was observed due to probalbe
saturation of the metabolism process. Further studies are needed to confirm
these preliminary results.

Abstract Number: NULL

Conference Year: 2000

New link: NULL

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