Study Comparing Thyrogen Versus a Modified Release of Recombinant Human Thyroid Stimulating Hormone
Condition: Healthy
Study type: Interventional
Phase: Phase 1

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.
    


Intervention name(s): Modified Release rhTSH
Intervention type(s): Drug
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Multinodular goiter