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Trial · NCT03102177

Effect of Age, Weight and Sex on Levothyroxine Pharmacokinetics

NCT03102177, Early phase 1, Completed, Georgetown University

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Effect of Age, Weight and Sex on Levothyroxine Pharmacokinetics. Trials, record NCT03102177. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03102177

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Effect of Age, Weight and Sex on Levothyroxine Pharmacokinetics
NCT number
NCT03102177
Status
Completed
Phases
Early phase 1
Enrollment
41 participants, actual
Lead sponsor
Georgetown University
Conditions
Hypothyroidism Primary
Interventions
Administration of stable Isotope labeled levothyroxine
First posted
2017-04-05
Last updated
2017-04-06

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryCL/F120 hoursoral clearance rate (defined as the ratio of dose administered to AUC0-∞)
PrimaryV/F120 hoursapparent volume of distribution (estimated by CL/F/ λ)
Primaryt-half120 hoursthe half-life of the terminal disposition phase (t-half) estimated by ln(2)/λ .
SecondaryCL/F analysed by age groups120 hours
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.
SecondaryV/F analysed by age groups120 hours
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.
Secondaryt-half by age groups120 hours
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.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03102177

GET https://conductscience.org/api/trials/v1/NCT03102177/registered