RECRUITING

Evaluation of K9 in Subjects With Thyroid Eye Disease (TED)

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study is comprised of two cohorts. Cohort 1 will examine pharmacokinetics of K9 in 3 healthy volunteers over 24 hours. This cohort has been completed. Cohort 2 will involve up to 10 patients with TED. Patients will receive oral K9 BID for up to 24 weeks and will be followed up to a total of 26 weeks with a primary endpoint of safety.

Official Title

Evaluation of K9 in Subjects With Thyroid Eye Disease (TED)

Quick Facts

Study Start:2024-11-06

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06467435

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Subject is willing and able to receive treatment and complete corresponding assessments as required by the protocol * Diagnosed with Thyroid Eye Disease (TED). * Symptomatic TED diagnosed no more than 9 months earlier. * Clinical Activity Score ≥ 3 (on 7 point scale) for the worse eye. * Subject is willing and able to receive treatment and complete corresponding assessments as required by the protocol.	* Body weight less than 55 kg. * History of any clinically significant medical disorders the principal investigator considers exclusionary, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease. * Females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception. * History or current evidence of hypersensitivity to any components of the study medication, as assessed by the investigator. * Participation in any systemic experimental treatment or any other systemic investigational new drug within 6 weeks or 5 half-lives of the active ingredient (whichever is longer) prior to the start of study treatment. Clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary * Body weight less than 55 kg. * Females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception. * History or current evidence of hypersensitivity to any components of the study medication, as assessed by the investigator. * Participation in any investigational drug or ocular device study within 30 days prior to the Day 1 Study Visit. * History or current evidence of a medical condition that may, in the opinion of the investigator, preclude the safe administration of study medication or affect the results of the study. * Participation in any systemic experimental treatment or any other systemic investigational new drug within 5 half-lives of the active ingredient prior to the start of study treatment. Clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary. * History of use of teprotumumab (Tepezza), radiotherapy, or orbital surgery. * History (last 6 weeks) of use of systemic immunosuppressants (e.g. mycophenolate), intravenous immunoglobulin, or plasmapheresis. * Clinical activity score \< 3 * Uncontrolled diabetes or hypertension * History of mental / psychiatric disorder * Hepatic dysfunction (Albumin (Alb), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline phosphates levels must be within normal range for eligibility) * Renal impairment (Urea, Creatinine, and Glomerular Filtration Rate levels must be within normal range) * Any baseline condition that the principal investigator considers exclusionary.

Inclusion Criteria

Exclusion Criteria

* Subject is willing and able to receive treatment and complete corresponding assessments as required by the protocol
* Diagnosed with Thyroid Eye Disease (TED).
* Symptomatic TED diagnosed no more than 9 months earlier.
* Clinical Activity Score ≥ 3 (on 7 point scale) for the worse eye.
* Subject is willing and able to receive treatment and complete corresponding assessments as required by the protocol.

* Body weight less than 55 kg.
* History of any clinically significant medical disorders the principal investigator considers exclusionary, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease.
* Females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception.
* History or current evidence of hypersensitivity to any components of the study medication, as assessed by the investigator.
* Participation in any systemic experimental treatment or any other systemic investigational new drug within 6 weeks or 5 half-lives of the active ingredient (whichever is longer) prior to the start of study treatment. Clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary
* Body weight less than 55 kg.
* Females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception.
* History or current evidence of hypersensitivity to any components of the study medication, as assessed by the investigator.
* Participation in any investigational drug or ocular device study within 30 days prior to the Day 1 Study Visit.
* History or current evidence of a medical condition that may, in the opinion of the investigator, preclude the safe administration of study medication or affect the results of the study.
* Participation in any systemic experimental treatment or any other systemic investigational new drug within 5 half-lives of the active ingredient prior to the start of study treatment. Clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary.
* History of use of teprotumumab (Tepezza), radiotherapy, or orbital surgery.
* History (last 6 weeks) of use of systemic immunosuppressants (e.g. mycophenolate), intravenous immunoglobulin, or plasmapheresis.
* Clinical activity score \< 3
* Uncontrolled diabetes or hypertension
* History of mental / psychiatric disorder
* Hepatic dysfunction (Albumin (Alb), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline phosphates levels must be within normal range for eligibility)
* Renal impairment (Urea, Creatinine, and Glomerular Filtration Rate levels must be within normal range)
* Any baseline condition that the principal investigator considers exclusionary.

Contacts and Locations

Study Contact

Connie Dampier

CONTACT

859-562-0750

dampier@email.uky.edu

Principal Investigator

Peter Timoney

PRINCIPAL_INVESTIGATOR

University of Kentucky

Study Locations (Sites)

University of Kentucky

Lexington, Kentucky, 40506

United States

Collaborators and Investigators

Sponsor: Peter Timoney

Peter Timoney, PRINCIPAL_INVESTIGATOR, University of Kentucky

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-06

Study Completion Date2027-08

Study Record Updates

Study Start Date2024-11-06

Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

Kamuvudine-9
K9

Additional Relevant MeSH Terms

Thyroid Eye Disease