Assessment of Blood From Men Receiving Oral TU in Various Collection Tubes
- Registration Number
- NCT03973840
- Lead Sponsor
- Clarus Therapeutics, Inc.
- Brief Summary
To describe the rate of post-collection TU to testosterone conversion, as manifested by increases in testosterone concentration, in Plain tubes held at room temperature and sodium fluoride (NaF)-ethylenediaminetetraacetic acid (EDTA) tubes held at room temperature or on ice prior to centrifugation
- Detailed Description
This was an open-label, non-randomized, single-sequence study in which men dosed with JATENZO had blood drawn into 3 different types of blood-collection tubes (ie, Plain, EDTA, and NaF-EDTA). These tubes were then processed in different ways (ie, different durations between phlebotomy and centrifugation, different holding temperatures \[room temperature or on ice\] between phlebotomy and centrifugation). After defined periods of incubation, the tubes were centrifuged and the serum/plasma transferred into vials and frozen. The testosterone and TU levels in the serum/plasma were then measured using validated liquid chromatography/tandem mass spectrometry assays.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 13
Subjects were required to meet all of the following criteria in order to be eligible for the study:
- Male (gender at birth) 18 to 65 years of age, inclusive, and legally able to give informed consent, as applicable by law. The percentage of non-Hispanic and Hispanic men was specified to be approximately ≥ 70% and ≤ 30%, respectively.
- Adequate venous access in the left or right arm to allow collection of a number of blood samples via a venous cannula or needle sticks
- Naïve to androgen-replacement therapy
- Willing to consume the entire protocol-specified breakfast and dinner meals
- Average screening systolic blood pressure < 140 mmHg and/or diastolic blood pressure < 90 mmHg
- Voluntarily gave written informed consent to participate in this study -
Subjects who met any of the following criteria were not eligible for participation in this study:
- History of hypertension or taking anti-hypertensive medications
- Intercurrent disease deemed clinically significant, in the opinion of the Investigator, of any type; in particular, liver, kidney, uncontrolled or poorly controlled heart disease, including congestive heart failure, coronary heart disease, heart attack or cerebrovascular accident in prior 6 months, or psychiatric-illness, including severe depression
- Electrocardiogram which Principal Investigator, or designate, believed was clinically significantly abnormal
- Intercurrent process or disease which could have impacted the absorption of JATENZO, in particular vomiting, nausea, diarrhea, or inflammatory bowel disease
- Current use of the following groups of drugs that affect testosterone levels, testosterone metabolism, or levels of testosterone metabolites, namely antiandrogens, 5 alpha reductase inhibitors (eg, dutasteride, finasteride), estrogens, long-acting opioid analgesics (eg, methadone hydrochloride, buprenorphine hydrochloride), or human growth hormone
- History of or was currently being evaluated for breast or prostate cancer
- Prostate specific antigen above the upper limit of normal
- Positive test for antibodies to human immunodeficiency virus type 1 or 2, hepatitis B surface antigen, or antibodies to hepatitis C virus at the Screening visit
- Positive urine drug test at the Screening visit
- Current treatment with oral lipase inhibitors (eg, orlistat [Xenical]), bile acid-binding resins (eg, cholestyramine [Questran], colestipol [Colestid]), fibric acid derivatives (eg, clofibrate [Atromid-X], gemfibrozil [Lopid]), and probucol (Lorelco).
- Smokers who were unable to refrain from smoking during the confinement period required in this study
- Current evidence of or history of abuse of alcohol or any drug substance within the previous 2 years
- Receipt of any drug as part of a research study within 30 days of initial dose administration in this study
- Blood donation (usually 550 mL) within the 12-week period before the initial study drug dose
- Hematocrit < 35% or > 50%
- Body mass index ≥ 31 kg/m2 -
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description healthy men treatment arm Testosterone Undecanoate Subjects were given 15 doses over 8 days, and then blood was drawn into several types of collection tubes at different storage conditions.
- Primary Outcome Measures
Name Time Method measure rate of post-collection TU-to-testosterone conversion in 3 types of collection tubes 8 days To describe the rate of post-collection TU to testosterone conversion, as manifested by increases in testosterone concentration, in Plain tubes held at room temperature and sodium fluoride (NaF)-ethylenediaminetetraacetic acid (EDTA) tubes held at room temperature or on ice prior to centrifugation
- Secondary Outcome Measures
Name Time Method rate of post-collection TU-to-testosterone conversion, as manifested by increases in testosterone concentration, in EDTA and NaF-EDTA collection tubes 8 days To describe the rate of post-collection TU to testosterone conversion, as manifested by increases in testosterone concentration, in EDTA and NaF-EDTA tubes held at room temperature or on ice prior to centrifugation
magnitude of overestimation of the true circulating testosterone concentration at 5 hours postdose 8 days To estimate the magnitude of overestimation of the true circulating testosterone concentration at 5 hours postdose, when blood was collected in various tubes and the tubes were held at room temperature or on ice.
healthy men's testosterone levels in serum and plasma 8 days To compare healthy men's testosterone levels in serum and plasma from Plain and EDTA tubes, respectively
Trial Locations
- Locations (1)
Clarus Therapeutics, Inc
🇺🇸Northbrook, Illinois, United States