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 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.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1 Single-Dose Study of the Pharmacokinetics of Sustained-Release Liothyronine Sodium (T3) in Healthy Subjects|
- Serum Total T3 [ Time Frame: Four Days. ] [ Designated as safety issue: No ]
|Study Start Date:||April 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Liothyronine, Sodium
Drug: Liothyronine, Sodium
Single 100-microgram (2 X 50 microgram) dose.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581463
|United States, District of Columbia|
|Georgetown University Hospital|
|Washington, District of Columbia, United States, 20007|