Study Comparing Thyrogen Versus a Modified Release of Recombinant Human Thyroid Stimulating Hormone
Status:
Completed
Trial end date:
2005-08-01
Target enrollment:
Participant gender:
Summary
Forty-six (46) eligible, healthy subjects who provide written informed consent will be
enrolled to participate in a 2 arm parallel group study to assess and compare the
pharmacokinetics and safety profile of Thyrogen dosed at 0.1 mg versus a modified release
formulation of recombinant human thyroid stimulating hormone (rhTSH) dosed at 0.1 mg. Ten
(10) of these subjects will have the thyroid uptake of radioiodine (123I) measured at
baseline and following their single dose of study medication. All doses will be administered
via intramuscular (IM) injection.
Following confirmation of study eligibility, subjects will be randomized in a 1:1 ratio to
receive either a single administration of 0.1 mg of Thyrogen (THYR) or 0.1 mg of the modified
release.
Randomization will be stratified by whether or not patients will have the thyroid uptake of
radioiodine (123I) measured following their single dose of study medication. Five (5)
patients in each treatment arm will have uptake measured, while 18 in each arm will not.
Each subject will have blood samples taken to determine the pharmacokinetics of serum TSH at
-12 hours and just prior to dosing and at various hours up to 14 days following the
administration of Thyrogen or the modified release formulation. In addition, for the
evaluation of pharmacodynamics, each subject will have samples of blood taken to determine
serum free T4, total T4, free T3, and total T3 at -12 hours and just prior to dosing and at
various hours up to 14 days following the administration of study treatments.
All subjects will undergo a 12-lead electrocardiogram (ECG) just prior to dose administration
and 1, 2, 3, 4, 5, 7, 10 and 14 days following study treatment administration. In addition,
subjects will undergo 24 hours of Holter monitoring at baseline and four (4) consecutive
24-hour Holter monitoring sessions post treatment to yield a total of 96 hours of continuous
monitoring of cardiac function following treatment administration. All subjects will undergo
ultrasound evaluations to determine thyroid volume at baseline and 48 hours following
treatment administration.
Twenty-four hours following the administration of Thyrogen or the modified release
formulation, a subset of five (5) subjects in each treatment arm will receive a dose of 123I
prepared to be 400µCi on the day of radioiodine administration based on the utilized nuclear
pharmacy's calibration schedule. Thyroid gland uptake will be measured via a probe in these
10 subjects at 6, 24 and 48 hours following radioiodine administration.
Blood chemistry, complete blood count (CBC), urinalysis and a physical exam will be conducted
14 days after treatment administration, or at the time of early termination, as a final
safety assessment.
Each subject's duration of study participation will be approximately 4 weeks.