A Study of Sustained-Release Liothyronine Sodium (T3) in Healthy Subjects

Study Overview
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Brief Summary
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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: Increased shelf stability to ensure the maintenance of claimed dosage. A sustained-release profile to minimize side effects associated with spikes in serum T3 levels. Uniformity of dose between production batches and between tablets.

Official Title
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Phase 1 Single-Dose Study of the Pharmacokinetics of Sustained-Release Liothyronine Sodium (T3) in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Liothyronine, Sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults Must be able to swallow tablets Exclusion Criteria: Hypothyroid Disease Pregnant Females

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liothyronine, Sodium<br>Healthy adults. | Drug: Liothyronine, Sodium<br>* Single 100-microgram (2 X 50 microgram) dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Total T3 |  | Four Days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics of oral T3