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I have been in the middle of designing a PK study for a "new" drug,
oxypurinol and was planning on using healthy volunteers for the PK and
PD analysis. I have been told by several individuals that I should use
actual hyperuricemic patients instead. I'm not comfortable with this
design as these people are most likely on several different medications
as well, and there will be no way, in my idea, of determining the true
pharmacokinetics of the drug. If it were chemo, that would be one
thing. You can't exactly start giving cytotoxic drugs to healthy
So who's "right"? What do I need to consider if I do design the study
with hyperuricemic patients? - I will never get accrual if I exclude
previous meds in the last 7-14 days.
Should the study include only healthy individuals and I need to build my
argument for this cause?
I am an oncology pharmacist by training, not as pharmacokineticist, (nor
do I work with any) so I really need some input from the members of this
David Claghorn, Pharm.D.
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I agree with your proposal of using healthy normal subjects for a PK/PD study.
If the drug's safety profile is good then there is no ethical concern in using
healthy subjects and you will get cleaner data. Later when you have PK
information, you can possibly collect Population PK samples in your Phase III
studies. Recruitment of patients for PK and PD studies is very difficult. Some
of our clients have attempted to conduct drug drug interaction studies in
patients taking a drug and introducing the second drug. We have conducted
these types of studies in patients taking warfarin or digoxin and these
studies took considerable time. You may have to design a multiple dose study
to get pharmacodynamic data as well as look at single dose and steady state
pharmacokinetics. Wish you all the best in getting your point accross to your
colleagues in your organization.
Dyal Garg, Ph.D.
Clinical Research Services, Inc.
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