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

• Sponsor: Ipe, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01581463
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Liothyronine, Sodium	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 1 Single-Dose Study of the Pharmacokinetics of Sustained-Release Liothyronine Sodium (T3) in Healthy Subjects
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Liothyronine, Sodium Healthy adults.	Drug: Liothyronine, Sodium; Single 100-microgram (2 X 50 microgram) dose.

Outcome Measures

Primary Outcome Measures

1. Serum Total T3 [Four Days.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy adults

• Must be able to swallow tablets

Exclusion Criteria:

• Hypothyroid Disease

• Pregnant Females

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Georgetown University Hospital	Washington	District of Columbia	United States	20007

Sponsors and Collaborators

• Ipe, LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ipe, LLC
• ClinicalTrials.gov Identifier: NCT01581463
• Other Study ID Numbers: BCT303
• First Posted: Apr 20, 2012
• Last Update Posted: Aug 6, 2012
• Last Verified: Aug 1, 2012

• Keywords provided by Ipe, LLC: pharmacokinetics of oral T3

Study Results

No Results Posted as of Aug 6, 2012