NCT03102177

Brief Summary

This study was a prospective, single-center, open-label, non-randomized, pharmacokinetic study using stable isotope carbon-13 labeled levothyroxine

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started May 2011

Longer than P75 for early_phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2013

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 5, 2017

Completed
Last Updated

April 6, 2017

Status Verified

March 1, 2017

Enrollment Period

2.5 years

First QC Date

March 27, 2017

Last Update Submit

April 4, 2017

Conditions

Hypothyroidism Primary

Outcome Measures

Primary Outcomes (3)

  • CL/F

    oral clearance rate (defined as the ratio of dose administered to AUC0-∞)

    120 hours

  • V/F

    apparent volume of distribution (estimated by CL/F/ λ)

    120 hours

  • t-half

    the half-life of the terminal disposition phase (t-half) estimated by ln(2)/λ .

    120 hours

Secondary Outcomes (3)

  • CL/F analysed by age groups

    120 hours

  • V/F analysed by age groups

    120 hours

  • t-half by age groups

    120 hours

Study Arms (1)

Stable isotope arm

EXPERIMENTAL

Measurement of blood levels of labelled levothyroxine after administration of single oral dose of stable isotope levothyroxine

Drug: Administration of stable Isotope labeled levothyroxine

Interventions

Administration of stable Isotope labeled levothyroxineDRUG

Administration of single dose of stable isotope carbon-13 labeled levothyroxine and measurement of blood levels of stable isotope-labeled levothyroxine

Also known as: levothyroxine or synthroid
Stable isotope arm

Eligibility Criteria

Age21 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \>21 years at the time of consent
  • euthyroidism while undergoing treatment with LT4
  • no other serious illness
  • ability to give written informed consent.

You may not qualify if:

  • baseline hematocrit lower than 28.0%
  • TSH greater than 4.5 mIU/L
  • kidney dysfunction
  • concomitant use of drugs that affect thyroidal axis interactions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypothyroidism

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Open label prospective study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2017

First Posted

April 5, 2017

Study Start

May 31, 2011

Primary Completion

November 30, 2013

Study Completion

July 26, 2016

Last Updated

April 6, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share