Clinical trial · Interventional
Effect of Age, Weight and Sex on Levothyroxine Pharmacokinetics
Hypothyroidism Treatment in Aging and Thyroid Cancer
NCT03102177CI-TRIAL-00026830completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study was a prospective, single-center, open-label, non-randomized, pharmacokinetic study using stable isotope carbon-13 labeled levothyroxine
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypothyroidism Primary | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Administration of stable Isotope labeled levothyroxine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stable isotope arm
- description
- Measurement of blood levels of labelled levothyroxine after administration of single oral dose of stable isotope levothyroxine
- interventionNames
- Drug: Administration of stable Isotope labeled levothyroxine
Primary outcomes (3)
- measure
- CL/F
- timeFrame
- 120 hours
- description
- oral clearance rate (defined as the ratio of dose administered to AUC0-∞)
- measure
- V/F
- timeFrame
- 120 hours
- description
- apparent volume of distribution (estimated by CL/F/ λ)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * age \>21 years at the time of consent * euthyroidism while undergoing treatment with LT4 * no other serious illness * ability to give written informed consent. Exclusion Criteria: * baseline hematocrit lower than 28.0% * TSH greater than 4.5 mIU/L * kidney dysfunction * concomitant use of drugs that affect thyroidal axis interactions
References
Publications (0)
Data not yet available
No reference posted for this study.