Assessment of Blood From Men Receiving Oral TU in Various Collection Tubes

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.

Inclusion criteria

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 -

Exclusion criteria

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 -