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NCT01581463 · ClinicalTrials.gov registry record · Phase 1
A Study of Sustained-Release Liothyronine Sodium (T3) in Healthy Subjects
A Phase 1 study of Healthy, sponsored by Ipe.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT01581463: Completed Phase 1 study of Healthy, sponsored by Ipe.
NCT01581463 is a Phase 1 study of Healthy that has completed, run by Ipe. The registered enrollment target is 12 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01581463, a Phase 1 study of Healthy, has completed, sponsored by Ipe.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
Liothyronine is indicated for the treatment of primary hypothyroidism. Between 6 and 10 Million in the United States and 80 Million patients world-wide are hypothyroid, usually the result of autoimmune thyroiditis called Hashimoto's Disease. Hypothyroid symptoms result from low levels of thyroid hormones (T4 and T3) in the blood due to inadequate thyroid hormone production by the thyroid gland. Every tissue in the body is a thyroid hormone target and hypothyroid symptoms can be debilitating. BCT303 utilizes Liothyronine, Sodium as the active ingredient, the same Liothyronine salt utilized as the active ingredient in currently marketed products. The current "gold standard" for treatment of hypothyroidism are products containing Levothyroxine (T4). T4 is known to be a pro-hormone, converted to the more active hormone T3 by deiodinases in various tissues. Patients on Levothyroxine therapy alone are occasionally not euthyroid as measured by clinical presentation, a condition hypothesized to result from low levels of T3 from inadequate T4 to T3 conversion. In addition, the efficiency of conversion of T4 to T3 is variable and dependent on the patho-physiologic state of the patient. BCT303 contains Liothyronine, Sodium as the active ingredient. This product has a patented formulation and granulation procedure that solves multiple clinical and stability problems associated with T3-based products. Thus, BCT303 is designed to have: 1. Increased shelf stability to ensure the maintenance of claimed dosage. 2. A sustained-release profile to minimize side effects associated with spikes in serum T3 levels. 3. Uniformity of dose between production batches and between tablets.
Conditions Studied
Interventions
- DRUG Liothyronine, Sodium
Study Locations (1)
District of Columbia
- Georgetown University Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2012-04 |
| Phase | Phase 1 |
What the finished NCT01581463 record still lists
NCT01581463 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Liothyronine, Sodium is the first listed.
NCT01581463 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT01581463 about?
NCT01581463 is a clinical study titled "A Study of Sustained-Release Liothyronine Sodium (T3) in Healthy Subjects". Liothyronine is indicated for the treatment of primary hypothyroidism. Between 6 and 10 Million in the United States and 80 Million patients world-wide are hypothyroid, usually the result of autoimmune thyroiditis called Hashimoto's Disease. Hypothyroid symptoms result from low levels of thyroid hor...
What is the current status of trial NCT01581463?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2012-04.
What conditions does trial NCT01581463 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01581463?
The interventions under investigation include: Liothyronine, Sodium (DRUG).
Who is sponsoring clinical trial NCT01581463?
This trial is sponsored by Ipe, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01581463 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01581463's enrollment target sits among peer trials
12 996th of 1090 higher than 61 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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