Effects of TAK-448 in Middle-aged and Older Men With Low Testosterone
Condition: Low Testosterone
Intervention: TAK-448; TAK-448 Placebo
Intervention description: TAK-448 solution for subcutaneous injection; TAK-448 placebo-matching solution for subcutaneous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 17.0
Sex: Male
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      The purpose of this study is to evaluate the effects on serum testosterone (ST) after 6 weeks
      of subcutaneous (SC) administration of different doses and dosing frequencies of TAK-448 to
      middle-aged and older men with low ST levels.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has total serum testosterone (ST) levels less than 300 ng/dL at Screening.

          2. Has a body mass index (BMI) between 20.0 and 40.0 kg/m^2, inclusive at Screening.

          3. A male participant who is nonsterilized and sexually active with a female partner of
             childbearing potential agrees to use adequate contraception from the time of signing
             of informed consent throughout the duration of the study and for 12 weeks after the
             last dose.

        Exclusion Criteria:

          1. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary,
             hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality
             that may impact the ability of the participant to participate or potentially confound
             the study results. Participants will be excluded based on:

               1. Has a serum creatinine >2.0 milligrams per deciliter (mg/dL) at Screening.

               2. Is receiving dialysis treatment.

               3. Has an American Urological Association (AUA)/ International Prostate Symptom
                  Score (I-PSS) score of >19 or serum prostate-specific antigen (PSA) >4 nanogram
                  per milliliter (ng/mL) at Screening.

               4. Has thyrotropin (TSH) levels less than (<) 0.3 or >7.5 milli-international units
                  per liter (mIU/L) at Screening.

               5. Has systolic blood pressure >160 millimeter of mercury (mm Hg) or diastolic blood
                  pressure >100 mm Hg (if out of range may be repeated once for eligibility
                  determination) at Screening.

               6. Has luteinizing hormone (LH) >9.4 units per liter (U/L) at Screening.

               7. Is receiving insulin therapy.

               8. Has a hematocrit <30 percent (%) or >48% at Screening.

               9. Has a glycosylated hemoglobin (HbA1c) >8.0 at Screening (Cohort 1).

          2. Has type 2 diabetes mellitus defined as fasting blood glucose >125 mg/dL, glycosylated
             hemoglobin (HbA1c) >6.2%, or use of antidiabetic medication (Cohort 2 only).

          3. Has clinical evidence of anatomic or pathological hypothalamic/pituitary/testicular
             disease, such as (but not limited to) Klinefelter's syndrome, Kallmann's syndrome,
             systemic infiltrative diseases (hemochromatosis, sarcoidosis, Wilson's disease), or
             prior pituitary surgery.

          4. Has used gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists,
             antiandrogens, clomiphene, or other reproductive hormone-related agents within 6
             months prior to Screening.

          5. Has used anabolic therapies (testosterone, dehydroepiandrosterone [DHEA],
             androstendione, any other androgen, or recombinant human growth hormone) within 1 year
             of Screening.