Pharmacokinetics Clinical Trial
Official title:
CT 5002 An Open-label, Non-randomized, Monocentric Phase I Study Evaluating the Pharmacokinetic Profile of RhuDex® Using a Tablet Formulation
RhuDex® (code number AV1142742) is a novel, orally bioavailable, low molecular weight
modulator of co-stimulation of T lymphocytes. RhuDex® binds to the protein CD80 (also known
as B7-1) on the surface of antigen-presenting cells and inhibits its interaction with CD28
(but not with CTLA-4) presented by CD4+ T lymphocytes.
RhuDex® is being developed for the treatment of rheumatoid arthritis. To improve oral
bioavailability, the study drug has to be co-administered with an alkaline buffer that
increases gastric pH values. In previous in vitro and phase I studies, meglumine has been
identified as the most effective buffer. Study CT 5002 is designed to evaluate the
bioavailability of four increasing doses of RhuDex®, combined with a fixed amount of
meglumine using a tablet formulation, under fed and fasted conditions as well as with
co-administration of the proton pump inhibitor pantoprazole. Furthermore, dose/plasma
concentration proportionality for single dosing and accumulation effects for repeat dosing
of RhuDex® will be evaluated.
This is an open-label, non-randomized, monocentric Phase I study to evaluate the
pharmacokinetic profile of single-dosed and repeat-dosed RhuDex® using a tablet formulation
as well as to assess the effect of food and the effect with co-administration of a proton
pump inhibitor on the bioavailability of RhuDex®.
12 healthy male subjects will receive study medication in 8 different treatment periods in 4
subsequent steps A, B, C and D.
Within steps A and B, the subjects will receive different treatments (4 in A and 2 in B),
sequentially. There will be a wash-out period of at least 4 days between each of the 8
different treatments/treatment periods of steps A, B, C and D.
In Step A, each subject will receive increasing doses of RhuDex® in 4 subsequent treatments.
In Step B, each subject will receive 2 different doses of RhuDex® preceded by pantoprazole
intake, in 2 subsequent treatments, and in Step C the RhuDex® dosing will be preceded by a
standardized high-fat, high-calorie meal. In Step D, RhuDex® will be administered twice
daily for 7 days.
For assessing the pharmacokinetic profile of RhuDex® in steps A, B and C, blood samples will
be collected prior to and at different intervals after RhuDex® administration. In step D,
blood samples will be collected on Days 1, 2, 4 and 7. Cmin, Cmax, tmax, t½ term, CL/F,
AUC(0-t), and AUC(0-∞) of RhuDex® will be analyzed.
Safety will be evaluated by regular observation and documentation of AEs, vital signs,
physical examination, ECG, and laboratory parameters.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
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