| Eligibility |
Inclusion Criteria:
1. Subject must be a man 18 to 65 years of age, inclusive, with a prior clinical
diagnosis of hypogonadism (signs/symptoms consistent with hypogonadism and a low
testosterone level as defined by established criteria at the time of diagnosis) and at
least one T level < 300 ng/dL prior to the study.
2. Subject must be naïve to androgen replacement therapy or washed out of prior androgen
replacement therapies (wash out durations specified in exclusion criterion); that is,
be willing to cease current T treatment, or currently not be taking T treatment.
3. Subject agrees as part of signed informed consent to remain off all forms of T, except
for dispensed study drug, throughout the entire study.
4. Subject must have adequate venous access in the left or right arm to allow collection
of blood samples.
5. Subject must be able and willing to provide written informed consent and comply with
the trial protocol and procedures.
Exclusion Criteria:
- Subject will be excluded if 1 or more of the main exclusion is applicable:
1. Subject with a history of hypopituitarism or multiple endocrine deficiencies
whether or not on stable doses of thyroid hormone and adrenal replacement
hormones.
2. Subject with a current or prior history of AI.
3. Subject is currently receiving corticosteroids.
4. On the CST at Screen 3, the maximum serum total cortisol at both the 30- and
60-minute timepoint is = 14 mcg/dL or has a baseline CBG outside the reference
range.
5. Subject with a history of a short course (2 weeks or less) of any glucocorticoids
within the past 3 months or anabolic steroids other than testosterone within the
past 6 months.
6. Subject with a history of a protracted course of any glucocorticoid therapy
(e.g., inhaled nasal steroids, inhaled oral steroids, topical steroids,
injectable steroids such as joint injections) or anabolic steroids other than
testosterone.
7. Subject with a history of anabolic steroid abuse.
8. Subject with a diagnosis of hypogonadism who has received any topical (e.g., gel
or patch), intranasal, or buccal T therapy within the previous 2 weeks,
intramuscular T injection of short-acting duration (e.g., T enanthate, T
cypionate) within the previous 4 weeks, intramuscular T injection of long-acting
duration (e.g., AVEED®) within the previous 20 weeks, T implantable pellets
(Testopel®) product within the previous 6 months or any prior use of an oral
testosterone product.
9. Subject has received any drug as part of another research study within 30 days of
initial dose administration in this study.
10. Subject has significant intercurrent disease (e.g., liver, kidney, inflammatory
bowel disease, uncontrolled or poorly controlled heart disease, including
hypertension, thromboembolism, congestive heart failure, or coronary heart
disease, psychiatric illness, including severe depression), which in the opinion
of the Investigator, would affect study participation or interpretation of study
assessments.
11. Subject has untreated, severe obstructive sleep apnea.
12. Subject has clinically significant abnormal laboratory values, including serum
transaminases > 2 × upper limits of normal (ULN), serum bilirubin > 1.5 × ULN
(except subjects with Gilbert syndrome) and serum creatinine > 1.5 × ULN.
13. Subject has a HCT value of < 35% or > 48%.
14. Subject has a history of polycythemia, either idiopathic or associated with TRT
treatment.
15. Subject is diabetic with a glycosylated hemoglobin > 8.5%.
16. Subject has a body mass index (BMI) = 38 kg/m2.
17. Subject has had a recent (within 2 years) history of stroke, transient ischemic
attack, or acute coronary event.
18. Subject has a mean (triplicate assessments) systolic blood pressure (sBP) > 140
mm Hg and/or diastolic blood pressure (dBP) > 90 mm Hg at screening (if
prescribed antihypertensives, subject should be taking medications on the day of
the screening visit with a sip of water).
19. Subject has had recent (within 2 years) history of angina or stent (coronary or
carotid) placement.
20. Subject does not meet the requirements for concomitant medication as outlined
below:
1. If hypertensive, on a stable dose of antihypertensive medication for < 3
months
2. If diabetic, on a stable dose of oral medication for < 2 months
3. If on anticonvulsant therapy, on a stable dose for < 3 months
4. If on lipid lowering medications, on a stable dose for < 3 months. Subject
is expected to remain on a stable dose of lipid-lowering medication(s)
throughout the study.
21. Subject has an abnormal prostate DRE (palpable nodules), elevated PSA (serum PSA
> 4.0 ng/mL), I-PSS > 19 points at screening.
22. Subject has a history of, or current or suspected prostate cancer.
23. Subject has a history of, or current or suspected breast cancer.
24. Subject currently using a drug known to affect T levels, T metabolism or levels
of T metabolites. These include: 5-alpha-reductase inhibitors (e.g., dutasteride,
finasteride), estrogens, long-acting opioid analgesics (e.g., methadone
hydrochloride, buprenorphine hydrochloride), human growth hormone (HGH) or
over-the-counter supplements purported to "boost" testosterone, sexual function
or improve prostate symptoms.
25. Subject use of dietary supplements such as saw palmetto or phytoestrogens and any
dietary supplements that may increase total T, such as androstenedione or
dehydroepiandrosterone within the previous 4 weeks.
26. Subject use of any over-the-counter "adrenal supplements".
27. Subject is not willing to stop all supplemental biotin 3 days prior to testing at
intervals described in this protocol.
28. Subject currently using Megace, atypical anti-psychotics (e.g., clozapine,
aripiorazole, asenapine, lumateperone, olanzapine, paliperidone, aripiprazole,
ziprasidone, cariprazine, risperidone, pimavanserin, ioperidone, brexpiprazole,
lurasidone, quetiapine) or chronic benzodiazepine use.
29. Subject has a history of abnormal bleeding tendencies or thrombophlebitis
unrelated to venipuncture or intravenous cannulation within the previous 2 years.
30. Subject has history of abuse of alcohol or any drug substance within the previous
2 years.
31. Subject deemed to be a compliance risk or unlikely to keep clinic appointments.
32. Subject donated blood (= 500 mL) within the 12-week period before the initial
study dose.
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