NCT03102177

Effect of Age, Weight and Sex on Levothyroxine Pharmacokinetics

Hypothyroidism Treatment in Aging and Thyroid Cancer

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hypothyroidism Primary

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2011-05-31
• Primary completion: 2013-11-30
• Completion: 2016-07-26
• First posted: 2017-04-05
• Last updated: 2017-04-06

Regulatory

• FDA-regulated drug study