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Dear all-
I am planning a dose-escalating safety and PK study in healthy
subjects with a compound which causes urine to become pink/purple. In
order to evaluate tolerability of the active compound, a blinded
placebo treatment arm is planned. Will this blinded placebo
treatment still be useful given the likelihood that subjects (and
possibly the investigator) will become unblinded due to a change in
urine color (particularly if subjects receive both active and placebo
treatments over the course of the study)?
The compound has previously been administered IV, but this will be
the first oral dosing.
I would appreciate any insight or advice.
Kind Regards,
Joi Dunbar
Infinity Pharmaceuticals
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PharmPK - Discussions about Pharmacokinetics
Pharmacodynamics and related topics
Hi,
The question is how did you proceed then in the previous assay based
on iv administration?
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Dear joi,
this is very interesting case, as if suppose the active material of
your IP should act to change the colour of urine than it is not
posssible to be blind for investigator/subject. but ingrediants
involve in change in the colour of urine than ur placebo treatment
should work for blinding.
i think my comment which i wrote you must be aware.
any expert can more comment on that.
regards
paresh
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The following message was posted to: PharmPK
Dear Joi
May be it is a silly advice, but you could add to your patients's
diet some amount of beet-root, then all the group will have some
amount of red colour in the urine that will make difficult to
identify (with certanty) the treated group.
Best regards
Fabiana
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The following message was posted to: PharmPK
Dear Joi:
You are correct this fails to blind unless:
1)both the patient and the clinician are told that the may or may not
color the urine.
2) select an innocuous dye-phenyl red for inclusion in your placebo then
all urine will turn red
Ed O'Connor, PhD
Technical Director, Immunoanalytical
Tandem Laboratories
115 Silvia Street
West Trenton, New Jersey
609-228-0243
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