Clinical trial: A Clinical Trial to Evaluate the Pharmacokinetic Profiles and Safety of CKD-845 (NCT04673682)

Eligibility criteria:
Inclusion Criteria:

          1. Adult Male over 19 years old and under 65 years old at screening.

          2. Serum total testosterone level under 3.0 ng/mL at screening.

          3. Subjects who had 18.5 kg/m2 ≤ Body Mass Index(BMI) < 30.5 kg/m2 and a total body
             weight ≥ 55 kg.

               -  Body Mass Index(BMI) = Weight(kg) / [Height(m)]2

          4. Subjects without congenital/chronic diseases and without abnormal symptoms or
             diagnosis based on a medical examination within the last 3 years, except for
             hypogonadism.

          5. Subjects who were deemed to be appropriate as study subjects in accordance with the
             screening results (laboratory tests, vital signs, ECG etc.).

          6. Subjects who voluntarily signed an informed consent form approved by the Institutional
             Review Board(IRB) of each clinical study site and decided to participate in the study
             after being fully informed of the study prior to participation, including the
             objective, content of the clinical trial.

          7. Subjects who consent to the use of reliable contraception during the clinical trial.
             Subjects who have no plan of pregnancy and agree to not donate his sperm during the
             study period and up until 180 days after the last administration of investigational
             product.

          8. Subjects with the ability and willingness to participate during the study period.

        Exclusion Criteria:

          1. Subjects with a medical evidence or a history (excluding a hypogonadism, dental
             history of periodontal surgery, impacted wisdom teeth removal, etc.) of clinically
             significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary,
             cardiovascular, hepatic, psychiatric, neurologic or immune disease.

             1-1. Subjects with a severe acute/chronic physical and mental conditions that can
             increase risk or interfere with the interpretation of the results of test.

             1-2. Subjects who have a androgen-dependent tumor(e.g., prostate cancer, male breast
             cancer).

             1-3. Subjects with hypercalcemia associated with malignant tumors.

             1-4. Subjects with or with a history of liver tumors.

             1-5. Subjects with bone metastasis of cancer.

             1-6. Subjects being treated for an enlarged prostate.

             1-7. Subjects who have severe alcohol and/or drug abuse history within a year from
             screening.

             1-8. Insulin-dependent diabetes mellitus or uncontrolled non-insulin- dependent
             diabetes mellitus.

          2. Subjects with the following laboratory test results at screening:

             2-1. AST, ALT exceeding 2.5 times from the upper limit of normal.

             2-2. Total bilirubin exceeding 2.5 times from the upper limit of normal.

             2-3. Subjects had renal impairment(eGFR < 60 mL/min/1.73 m2)

             2-4. Positive results of virus/bacterial test and/or urine drug test at screening.

             2-5. Systolic blood pressure >150 mmHg or <90 mmHg and/or diastolic blood pressure >60
             mmHg or >95 mmHg at sitting position.

          3. History of regular alcohol consumption exceeding 210 g/week within 6 months prior to
             screening (1 drink (250 mL) of beer (5%) = 10 g, 1 drink (50 mL) of hard liquor (20%)
             = 8 g; 1 drink (125 mL of wine (12%) = 12 g).

          4. Subjects who smoked more than 20 cigarettes per day within 6 months prior to
             screening.

          5. Subjects who had been administered investigational product(s) from other clinical
             study or bioequivalence study within 180 days prior to the first dose of this
             study(except when subject have not taken investigational product(s)).

          6. Subjects who had taken any drug(s) known as a strong inducer(s) or inhibitor(s) of
             drug-metabolizing enzymes within 30 days prior to the first dose of investigational
             product(s).

          7. Subjects who had taken any contraindication drug(s)(Drug influencing the level of
             serum testosterone, modulating activity of testosterone and which have drug
             interaction) within 28 days prior to the first dose of investigational product(s).

          8. Subjects who use of oral anticoagulants (with the exception of low-dose aspirin)
             within 28 days prior to the first dose of investigational product(s).

          9. Subjects who use the testosterone pellet within 90 days prior to the first dose of
             investigational product(s).

         10. Subjects who use of any injectable testosterone preparations within 28 days prior to
             the first dose of investigational product(s).

         11. Subjects who use oral testosterone products within 7 days prior to the first dose of
             investigational product(s).

         12. Subjects who use of supplements (e.g., saw palmetto, phytoestrogen, androstenedione,
             DHEA, niacin, fish oil etc.) prior to the first dose of investigational product(s).

         13. Subjects who have hypersensitivity of investigational products and its components.

         14. Subjects who donated whole blood within 60 days or blood components within 30 days
             prior to the first dose of the investigational product(s).

         15. Subjects who were deemed inappropriate to participate in the study by the
             investigator.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 19-year-old male came to clinic with some sexual concern.  He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates.  On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH.

Patient description (patient's own words): I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels.

Does the patient match the trial criteria? Entailment