Effect of Age, Weight and Sex on Levothyroxine Pharmacokinetics
NCT ID: NCT03102177
Last Updated: 2017-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
EARLY_PHASE1
41 participants
INTERVENTIONAL
2011-05-31
2016-07-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Coffee on the Absorption of Thyroid Hormone in Patients With Thyroid Carcinoma
NCT01707056
A Study of T3 Therapy in Patients With Hypothyroidism
NCT01800617
Effect of T4-T3 Combination Therapy Versus T4 Monotherapy in Patients With Hypothyroidism
NCT00531713
Mechanistic Study of Subclinical Hypothyroidism In the Elderly
NCT02399475
Dosing of LT4 in Older Individuals
NCT06073665
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Stable isotope arm
Measurement of blood levels of labelled levothyroxine after administration of single oral dose of stable isotope levothyroxine
Administration of stable Isotope labeled levothyroxine
Administration of single dose of stable isotope carbon-13 labeled levothyroxine and measurement of blood levels of stable isotope-labeled levothyroxine
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Administration of stable Isotope labeled levothyroxine
Administration of single dose of stable isotope carbon-13 labeled levothyroxine and measurement of blood levels of stable isotope-labeled levothyroxine
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* euthyroidism while undergoing treatment with LT4
* no other serious illness
* ability to give written informed consent.
Exclusion Criteria
* TSH greater than 4.5 mIU/L
* kidney dysfunction
* concomitant use of drugs that affect thyroidal axis interactions
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Georgetown University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-572
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.