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

NCT01581463 | Completed Phase 1 DMC

• 1 other identifier: BCT303
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

pharmacokinetics of oral T3

Outcome Measures

Primary Outcomes (1)

• Serum Total T3

  Four Days.

Study Arms (1)

Liothyronine, Sodium

ACTIVE COMPARATOR

Healthy adults.

Drug: Liothyronine, Sodium

Interventions

Liothyronine, Sodium DRUG

Single 100-microgram (2 X 50 microgram) dose.

Liothyronine, Sodium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults
• Must be able to swallow tablets

You may not qualify if:

• Hypothyroid Disease
• Pregnant Females

Sponsors & Collaborators

• Ipe, LLC: lead

Study Sites (1)

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Interventions

Triiodothyronine

Intervention Hierarchy (Ancestors)

Thyronines; Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Thyroxine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2012
• First Posted: April 20, 2012
• Study Start: April 1, 2012
• Primary Completion: August 1, 2012
• Last Updated: August 6, 2012

Record last verified: 2012-08

Locations

US (1)