HealthyPhase 1NCT00137891
Study Comparing Thyrogen Versus a Modified Release of Recombinant Human Thyroid Stimulating Hormone
A Phase 1 study testing Modified Release rhTSH in people with Healthy, run by Genzyme, a Sanofi Company at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Modified Release rhTSH
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Aug 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Committed to follow the protocol requirements as evidenced by providing written informed consent prior to any study-related procedures being performed
- Males or females, in good general health, between the ages of 18 and 40, inclusive. Females of childbearing potential must be on a stable hormonal contraceptive regimen (defined as > 6 months continuous use) and/or utilize a double barrier method, i.e., condom and foam. It is recommended that female sexual partners of male subjects utilize the above described method of birth control while their partners are participating in the study.
- A negative serum pregnancy test prior to entering the study (all women regardless of child bearing potential)
- Physical examination, including vital signs and laboratory assessments that are within normal limits at the time of screening. If abnormalities are noted, they must be deemed clinically insignificant, based on the investigator's judgment, to satisfy inclusion criteria.
- Electrocardiogram (ECG) and Holter results within normal limits at screening. Subjects who have ECG findings of occasional premature atrial beats, abnormal PR intervals not associated with supraventricular tachycardia (SVT) or heart block, right bundle branch block, sinus tachycardia at rest (heart rate [HR] < 100 beats per minute [BPM]) and sinus bradycardia (HR > 50 BPM) may be included in this study.
- Urine and plasma drug screens are negative for drugs of abuse at the time of screening
Show all 10Show fewer
- Willing and able to abstain from alcohol 48 hours prior to and post each administration of Thyrogen and otherwise limit all alcohol consumption to < 2 drinks per day while participating in the study
- Absence of or current smoking habit of < 10 cigarettes per day while participating in the study
- Baseline levels of total T3, free T3, free T4, T4, and TSH levels within the normal range
- Body mass index (BMI) < 30
Who cannot join
- Any history of cardiovascular disease
- Uncontrolled hypertension as defined by a resting blood pressure of > 140/90 mm Hg (resting defined as 5 minutes sitting/supine position)
- Currently or within the past 5 years a history of malignancy, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix
- A concurrent major medical disorder (e.g., documented cardiac disease, debilitating cardiopulmonary disease, advanced renal failure, advanced liver disease, advanced pulmonary disease, or advanced cerebral vascular disorder) and may be too ill to adequately comply with the requirements of this study
- ECG or Holter abnormalities that may be suggestive of underlying cardiac disease including: left atrial abnormality and/or left ventricular hypertrophy, frequent ectopic or multifocal atrial beats, frequent premature ventricular beats, significant conduction abnormalities such as widened QRS, left bundle branch block, significant axis deviation, atrial fibrillation or flutter, frequent premature ventricular contractions or ventricular tachycardia (including torsades de point), repolarization changes suggestive of myocardial ischemia (e.g., ST-T wave abnormalities suggestive of ischemia), evidence of a previous myocardial infarction, atrioventricular (AV) nodal reentrant tachycardia or tachycardias associated with preexcitation/accessory pathway syndromes and high grade AV block
- A non-thyroidal condition known to affect 123I uptake (e.g., congestive heart failure class III or IV, renal failure)
Show all 12Show fewer
- Currently taking drugs that may affect thyroid or renal function (e.g., corticosteroids, diuretics, lithium, amiodarone, or other prescribed iodine-containing medication)
- Women of childbearing potential unless taking medically acceptable contraceptive precautions
- Women who are pregnant or lactating
- A current diagnosis or recent history, within the past 2 years, of alcoholism, drug abuse, or severe emotional, behavioral or psychiatric problems that, in the opinion of the Investigator, would hinder adequate compliance with the requirements of this study
- Currently participating in another investigational drug study or have participated in such a study within 30 days of their enrollment in this study
- Have schedule or travel plans that prevent the completion of all required visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study Comparing Pharmacokinetics and Safety Profile of Thyrogen Versus a Modified Release of Recombinant Human Thyroid Stimulating Hormone
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.
Read more
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.
- Conditions
- Healthy
- Being tested
- Modified Release rhTSH
- Keywords
- Multinodular goiter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Release rhTSHDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess and compare the pharmacokinetics (PK) of a single intramuscular (IM) administration of 0.1 mg of Thyrogen versus a single IM administration of 0.1 mg modified release formulation of rhTSH in healthy subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startJun 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 46 participants
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137891
- Sponsor's protocol ID
- THYR01205
- Status last verified
- Mar 2015
- First submitted
- 26 Aug 2005
- Last updated
- 18 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study Comparing Pharmacokinetics and Safety Profile of Thyrogen Versus a Modified Release of Recombinant Human Thyroid Stimulating Hormone
- ClinicalTrials.gov ID
- NCT00137891
- Acronym / sponsor ID
- THYR01205
- Conditions
- Healthy
- Keywords
- Multinodular goiter
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Study completion
- Aug 2005
- First posted
- 30 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Committed to follow the protocol requirements as evidenced by providing written informed consent prior to any study-related procedures being performed
- Males or females, in good general health, between the ages of 18 and 40, inclusive. Females of childbearing potential must be on a stable hormonal contraceptive regimen (defined as > 6 months continuous use) and/or utilize a double barrier method, i.e., condom and foam. It is recommended that female sexual partners of male subjects utilize the above described method of birth control while their partners are participating in the study.
- A negative serum pregnancy test prior to entering the study (all women regardless of child bearing potential)
- Physical examination, including vital signs and laboratory assessments that are within normal limits at the time of screening. If abnormalities are noted, they must be deemed clinically insignificant, based on the investigator's judgment, to satisfy inclusion criteria.
- Electrocardiogram (ECG) and Holter results within normal limits at screening. Subjects who have ECG findings of occasional premature atrial beats, abnormal PR intervals not associated with supraventricular tachycardia (SVT) or heart block, right bundle branch block, sinus tachycardia at rest (heart rate [HR] < 100 beats per minute [BPM]) and sinus bradycardia (HR > 50 BPM) may be included in this study.
Key exclusion criteria (12 listed)
- Any history of cardiovascular disease
- Uncontrolled hypertension as defined by a resting blood pressure of > 140/90 mm Hg (resting defined as 5 minutes sitting/supine position)
- Currently or within the past 5 years a history of malignancy, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix
- A concurrent major medical disorder (e.g., documented cardiac disease, debilitating cardiopulmonary disease, advanced renal failure, advanced liver disease, advanced pulmonary disease, or advanced cerebral vascular disorder) and may be too ill to adequately comply with the requirements of this study
- ECG or Holter abnormalities that may be suggestive of underlying cardiac disease including: left atrial abnormality and/or left ventricular hypertrophy, frequent ectopic or multifocal atrial beats, frequent premature ventricular beats, significant conduction abnormalities such as widened QRS, left bundle branch block, significant axis deviation, atrial fibrillation or flutter, frequent premature ventricular contractions or ventricular tachycardia (including torsades de point), repolarization changes suggestive of myocardial ischemia (e.g., ST-T wave abnormalities suggestive of ischemia), evidence of a previous myocardial infarction, atrioventricular (AV) nodal reentrant tachycardia or tachycardias associated with preexcitation/accessory pathway syndromes and high grade AV block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Release rhTSH | Drug | – |
Primary outcome
To assess and compare the pharmacokinetics (PK) of a single intramuscular (IM) administration of 0.1 mg of Thyrogen versus a single IM administration of 0.1 mg modified release formulation of rhTSH in healthy subjects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Modified Release rhTSH in people with Healthy, run by Genzyme, a Sanofi Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess and compare the pharmacokinetics (PK) of a single intramuscular (IM) administration of 0.1 mg of Thyrogen versus a single IM administration of 0.1 mg modified release formulation of rhTSH in healthy subjects. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2015.