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

History of Changes

Tracking Information
First Received Date ^ICMJE	April 18, 2012
Last Updated Date	August 3, 2012
Start Date ^ICMJE	April 2012
Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 19, 2012)	Serum Total T3 [ Time Frame: Four Days. ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01581463 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of Sustained-Release Liothyronine Sodium (T3) in Healthy Subjects
Official Title ^ICMJE	Phase 1 Single-Dose Study of the Pharmacokinetics of Sustained-Release Liothyronine Sodium (T3) in Healthy Subjects
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: 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Healthy
Intervention ^ICMJE	Drug: Liothyronine, Sodium Single 100-microgram (2 X 50 microgram) dose.
Study Arm (s)	Active Comparator: Liothyronine, Sodium Healthy adults. Intervention: Drug: Liothyronine, Sodium
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	12
Completion Date	Not Provided
Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Healthy adults Must be able to swallow tablets Exclusion Criteria: Hypothyroid Disease Pregnant Females
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01581463
Other Study ID Numbers ^ICMJE	BCT303
Has Data Monitoring Committee	Yes
Responsible Party	Ipe, LLC
Study Sponsor ^ICMJE	Ipe, LLC
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Ipe, LLC
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top