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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipe, LLC
ClinicalTrials.gov Identifier:
NCT01581463
First received: April 18, 2012
Last updated: August 3, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Healthy
Drug: Liothyronine, Sodium
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Ipe, LLC:

Primary Outcome Measures:
  • Serum Total T3 [ Time Frame: Four Days. ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: April 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Liothyronine, Sodium
Healthy adults.
Drug: Liothyronine, Sodium
Single 100-microgram (2 X 50 microgram) dose.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults
  • Must be able to swallow tablets

Exclusion Criteria:

  • Hypothyroid Disease
  • Pregnant Females
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01581463

Locations
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Ipe, LLC
  More Information

No publications provided

Responsible Party: Ipe, LLC
ClinicalTrials.gov Identifier: NCT01581463     History of Changes
Other Study ID Numbers: BCT303
Study First Received: April 18, 2012
Last Updated: August 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ipe, LLC:
pharmacokinetics of oral T3

ClinicalTrials.gov processed this record on October 19, 2014