Hypothyroidism PrimaryEarly Phase 1NCT03102177
Effect of Age, Weight and Sex on Levothyroxine Pharmacokinetics
A Early Phase 1 study testing Administration of stable Isotope labeled levothyroxine in people with Hypothyroidism Primary, run by Georgetown University.
Trial summary
This study was a prospective, single-center, open-label, non-randomized, pharmacokinetic study using stable isotope carbon-13 labeled levothyroxine Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hypothyroidism Primary
- What is being tested?
- Administration of stable Isotope labeled levothyroxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2011to 26 Jul 2016
- Phase
- Early 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >21 years at the time of consent
- euthyroidism while undergoing treatment with LT4
- no other serious illness
- ability to give written informed consent.
Who cannot join
- baseline hematocrit lower than 28.0%
- TSH greater than 4.5 mIU/L
- kidney dysfunction
- concomitant use of drugs that affect thyroidal axis interactions
About this study
Official title: Hypothyroidism Treatment in Aging and Thyroid Cancer
This study was a prospective, single-center, open-label, non-randomized, pharmacokinetic study using stable isotope carbon-13 labeled levothyroxine
Read the detailed description
Setting The study was conducted on the clinical research unit of an academic medical center.
Participants Adults of any age being treated with levothyroxine for hypothyroidism were studied.
Interventions A single dose of 13C- LT4 was administered to hypothyroid subjects taking levothyroxine replacement.
Main Outcomes and Measures Eighteen serial plasma samples were collected. One sample was obtained before the 13C- LT4 dose and the remainder over the 312-hour period post-dosing. 13C- LT4 concentration was quantified using validated liquid chromatography tandem mass spectrometry methods. Pharmacokinetic analysis was conducted using linear log trapezoidal non-compartmental analysis using Phoenix 6.4.
- Conditions
- Hypothyroidism Primary
- Being tested
- Administration of stable Isotope labeled levothyroxine
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of stable Isotope labeled levothyroxineDrug
Also called levothyroxine or synthroid
Administration of single dose of stable isotope carbon-13 labeled levothyroxine and measurement of blood levels of stable isotope-labeled levothyroxine
| Study group | Role | What they receive |
|---|---|---|
| Stable isotope arm | Experimental | Measurement of blood levels of labelled levothyroxine after administration of single oral dose of stable isotope levothyroxine Receives: Drug: Administration of stable Isotope labeled levothyroxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
CL/F
oral clearance rate (defined as the ratio of dose administered to AUC0-∞)
Measured: 120 hours
V/F
apparent volume of distribution (estimated by CL/F/ λ)
Measured: 120 hours
t-half
the half-life of the terminal disposition phase (t-half) estimated by ln(2)/λ .
Measured: 120 hours
Secondary outcomes (3)
CL/F analysed by age groups
CL/F will be compared in adults (age ≤60 years) versus elderly (age>60 years) using Wilcoxon signed-rank test using significance level of α = 0.05. Additionally, these PK parameters were regressed against age (as a continuous covariate).
Sex (male or female), weight (as a continuous covariate), and body mass index (BMI) (as a continuous covariate) will be considered using a stepwise linear regression approach.
Measured: 120 hours
V/F analysed by age groups
V/F will be compared in adults (age ≤60 years) versus elderly (age>60 years) using Wilcoxon signed-rank test using significance level of α = 0.05. Additionally, these PK parameters were regressed against age (as a continuous covariate).
Sex (male or female), weight (as a continuous covariate), and body mass index (BMI) (as a continuous covariate) will be considered using a stepwise linear regression approach.
Measured: 120 hours
t-half by age groups
t-half will be compared in adults (age ≤60 years) versus elderly (age>60 years) using Wilcoxon signed-rank test using significance level of α = 0.05. Additionally, these PK parameters were regressed against age (as a continuous covariate).
Sex (male or female), weight (as a continuous covariate), and body mass index (BMI) (as a continuous covariate) will be considered using a stepwise linear regression approach.
Measured: 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start31 May 2011
- Primary completion30 Nov 2013
- Study completion26 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothyroidism PrimaryStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label prospective study
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102177
- Sponsor's protocol ID
- 2010-572
- Status last verified
- Mar 2017
- First submitted
- 27 Mar 2017
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypothyroidism Treatment in Aging and Thyroid Cancer
- ClinicalTrials.gov ID
- NCT03102177
- Acronym / sponsor ID
- 2010-572
- Conditions
- Hypothyroidism Primary
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- 31 May 2011 (actual)
- Primary completion
- 30 Nov 2013 (actual)
- Study completion
- 26 Jul 2016 (actual)
- First posted
- 5 Apr 2017 (actual)
- 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.
This study was a prospective, single-center, open-label, non-randomized, pharmacokinetic study using stable isotope carbon-13 labeled levothyroxine
Detailed description
Setting The study was conducted on the clinical research unit of an academic medical center.
Participants Adults of any age being treated with levothyroxine for hypothyroidism were studied.
Interventions A single dose of 13C- LT4 was administered to hypothyroid subjects taking levothyroxine replacement.
Main Outcomes and Measures Eighteen serial plasma samples were collected. One sample was obtained before the 13C- LT4 dose and the remainder over the 312-hour period post-dosing. 13C- LT4 concentration was quantified using validated liquid chromatography tandem mass spectrometry methods. Pharmacokinetic analysis was conducted using linear log trapezoidal non-compartmental analysis using Phoenix 6.4.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label prospective study
| Arm | Type | Receives |
|---|---|---|
| Stable isotope arm | Experimental | Drug: Administration of stable Isotope labeled levothyroxineMeasurement of blood levels of labelled levothyroxine after administration of single oral dose of stable isotope levothyroxine |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age >21 years at the time of consent
- euthyroidism while undergoing treatment with LT4
- no other serious illness
- ability to give written informed consent.
Key exclusion criteria (4 listed)
- baseline hematocrit lower than 28.0%
- TSH greater than 4.5 mIU/L
- kidney dysfunction
- concomitant use of drugs that affect thyroidal axis interactions
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 |
|---|---|---|
| Administration of stable Isotope labeled levothyroxineAlso: levothyroxine or synthroidAdministration of single dose of stable isotope carbon-13 labeled levothyroxine and measurement of blood levels of stable isotope-labeled levothyroxine | Drug | Stable isotope arm |
Primary outcome
CL/F
Time frame: 120 hours
oral clearance rate (defined as the ratio of dose administered to AUC0-∞)
V/F
Time frame: 120 hours
apparent volume of distribution (estimated by CL/F/ λ)
t-half
Time frame: 120 hours
the half-life of the terminal disposition phase (t-half) estimated by ln(2)/λ .
3 secondary outcomes
CL/F analysed by age groups
Time frame: 120 hours
V/F analysed by age groups
Time frame: 120 hours
t-half by age groups
Time frame: 120 hours
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 6 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Administration of stable Isotope labeled levothyroxine in people with Hypothyroidism Primary, run by Georgetown University.
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 4 inclusion and 4 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 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
CL/F (time frame: 120 hours). The study lists 3 primary outcomes in all. 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 6 Apr 2017.