Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00137891
Status:
COMPLETED
Last Update Posted:
2015-03-18
First Post:
2005-08-26
Brief Title:
Study Comparing Thyrogen Versus a Modified Release of Recombinant Human Thyroid Stimulating Hormone
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Phase I Study Comparing Pharmacokinetics and Safety Profile of Thyrogen Versus a Modified Release of Recombinant Human Thyroid Stimulating Hormone
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 01 mg versus a modified release formulation of recombinant human thyroid stimulating hormone rhTSH dosed at 01 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 11 ratio to receive either a single administration of 01 mg of Thyrogen THYR or 01 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 pharmacys 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 subjects duration of study participation will be approximately 4 weeks
Following confirmation of study eligibility subjects will be randomized in a 11 ratio to receive either a single administration of 01 mg of Thyrogen THYR or 01 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 pharmacys 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 subjects duration of study participation will be approximately 4 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None