A Study of Sustained-Release Liothyronine Sodium (T3) in Healthy Subjects
NCT ID: NCT01581463
Last Updated: 2012-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2012-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Liothyronine, Sodium
Healthy adults.
Liothyronine, Sodium
Single 100-microgram (2 X 50 microgram) dose.
Interventions
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Liothyronine, Sodium
Single 100-microgram (2 X 50 microgram) dose.
Eligibility Criteria
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Inclusion Criteria
* Must be able to swallow tablets
Exclusion Criteria
* Pregnant Females
18 Years
ALL
Yes
Sponsors
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Ipe, LLC
INDUSTRY
Responsible Party
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Locations
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Georgetown University Hospital
Washington D.C., District of Columbia, United States
Countries
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Other Identifiers
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BCT303
Identifier Type: -
Identifier Source: org_study_id