Healthy Clinical Trial
Official title:
Study of Thyrotropin Releasing Hormone in Patients With Thyroid or Pituitary Abnormalities
This study will determine the safety and activity of a new formulation of
thyrotropin-releasing hormone (TRH), a drug used for diagnosing and evaluating patients with
certain thyroid gland abnormalities. Normal thyroid gland function depends on proper chemical
signaling between the thyroid gland, the hypothalamus (the part of the brain where TRH is
made), and the pituitary (another part of the brain). The TRH test helps assess this
interaction. Production of the only FDA-approved preparation of TRH was stopped in July 2002.
As a result, to have a continuous source of TRH available for NIH clinical and research
purposes, the NIH Clinical Center (CC) Pharmacy Department produced a pharmaceutical grade
formulation of TRH for patient use. This study will test the CC formulation in healthy
volunteers to show that its activity and side effects are similar to those of the previously
available commercial test preparation. It will then be studied in CC patients for whom the
diagnostic test is recommended.
Healthy volunteers between 18 and 65 years of age and all patients requiring TRH evaluation
of hypothalamic-pituitary-thyroid gland interaction may be eligible for this study. Patients
include those with pituitary reserve, inconsistent thyroid function test, inappropriate TSH
secretion, or pre- and post-operative evaluation of pituitary tumors. Normal volunteers will
be screened with a medical history, physical examination, and blood tests. Women of
child-bearing potential will be given a pregnancy test; pregnant and breast-feeding women may
not participate.
The TRH test procedure will be the same for healthy volunteers and patients. All participants
fast from midnight before the morning of the test. In the morning, a catheter (flexible
plastic tube) is inserted into an arm vein for easy injection of the TRH and collection of
blood samples. Blood pressure is monitored before and during the test. A blood sample is
drawn, and then TRH is given through the catheter over a 1-minute period. Another nine blood
samples are collected over a 3-hour period from the time of the TRH injection for measuring
levels of various hormones. A total of less than 4 tablespoons of blood is taken for the
test.
Thyrotropin releasing hormone (TRH) is a neuropeptide used in the diagnostic evaluation of
patients with dysfunction of the hypothalamic-pituitary-thyroid (HPT) axis. In healthy
individuals, administration of TRH intravenously results in pituitary secretion of
thyrotropin [thyroid-stimulating hormone (TSH)], which in turn stimulates the thyroid gland
release of thyroid hormones; thyroxine (T4) and triiodothyronine (T3). TRH stimulates the
secretion of other pituitary hormones under normal physiologic as well as pathologic
conditions.
Under this protocol, TRH is used for routine diagnostic testing and research studies in
adults and children. It is produced by the Pharmaceutical Development Section of the Clinical
Center Pharmacy at the NIH. The safety, activity and comparability of this preparation were
demonstrated in a small group of normal volunteers prior to its release for diagnostic and
research use.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |