TAK-385 Phase I Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability Study
Condition: Healthy Volunteers
Intervention: [14C]-TAK-385 Oral Solution; TAK-385 Tablets; [14C]-TAK-385 Solution for Intravenous Infusion
Intervention description: TAK-385 oral radiolabelled solution; TAK-385 tablets 2 X 40 mg; TAK-385 intravenous (IV) radiolabelled solution
Intervention MeSH terms: Pharmaceutical Solutions; Relugolix
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this 2 part study is to look at how TAK-385 is taken up, broken down and
      removed from the body when given as a radiolabelled oral solution (by mouth) or as an oral
      tablet (by mouth) followed by a radiolabelled intravenous (IV) infusion (into the arm vein).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signs a written, informed consent form prior to the initiation of any study
             procedures.

          2. Is a healthy male, aged 18 to 55; inclusive on Day-1.

          3. Is capable of understanding and complying with protocol requirements.

          4. Weighs at least 50 kg and has a body mass index (BMI) between 18.0 and 35.0 kg/m^2,
             inclusive at Screening or Day-1.

          5. In the opinion of the investigator, is in good healthy condition on the basis of a
             pre-study physical examination, medical history, vital signs, electrocardiogram, and
             the results of blood biochemistry, hematology, and serology test and urinalysis at
             Screening and Day -1.

          6. A male participant who is nonsterilized and sexually active with a female partner of
             childbearing potential agrees to use adequate contraception from signing of informed
             consent throughout the duration of the study and for 90 days after last dose.

        Exclusion Criteria:

          1. Has received any investigational compound within 45 days prior to Day -1.

          2. Has received TAK-385 in a previous clinical study.

          3. Has a resting systolic blood pressure ≤90 mmHg or ≥140 mmHg and a resting diastolic
             blood pressure ≤50 mmHg or ≥90 mmHg in supine position at Screening or Day-1.

          4. QTc (Fridericia's correction) is >450 msec at Screening or at Day -1 as read on the
             printout of the ECG produced by the electrocardiogram (ECG) equipment and evaluated by
             the investigator

          5. Has active liver disease or jaundice, or with alanine aminotransferase (ALT),aspartate
             aminotransferase (AST), or bilirubin (total bilirubin) >1.5 times the upper limit of
             normal (ULN) in the clinical laboratory tests at VISIT 1 and 2. The participant has
             positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus
             antibody (anti-HCV) or known history of human immunodeficiency virus (HIV) at
             Screening.

          6. Has a resting pulse and heart rate (as read on ECG) <45 beats per minute (bpm) or >100
             bpm at Screening or Day -1.

          7. Has had an acute, clinically significant illness within 30 days prior to Day -1.

          8. Has a history or clinical manifestations of significant metabolic (including diabetes
             mellitus, hypercholesterolemia, or dyslipidemia), hematologic, pulmonary,
             cardiovascular,gastrointestinal, neurological, rheumatologic, skin and subcutaneous
             tissue disorders,infectious, hepatic, renal, urologic, immunologic, psychiatric or
             mood disorders (including any past history of suicide attempt), or history of lactose
             intolerance.

          9. Has a family history of bleeding disorders.

         10. Has current or recent (within 6 months) history of gastrointestinal disease that would
             be expected to influence the absorption of drugs (ie, history of
             malabsorption,esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent
             heartburn, or any surgical intervention).

         11. Has irregular defecation patterns (less than one defecation per two days or excessive
             diarrhea) and/or has a history of changes in bowel habits with daily routine or
             environment changes.

         12. Radiation exposure, including that from the present study, excluding background
             radiation but including diagnostic x-rays and other medical exposures, exceeding 5
             millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. No
             occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999,
             shall participate in the study

         13. Has a history of abdominal surgery (except laparoscopic cholecystectomy or
             uncomplicated appendectomy), thoracic or nonperipheral vascular surgery within 6
             months prior to Day - 1.

         14. Has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of
             the skin that has not been in remission for at least 5 years prior to Day 1.

         15. Has significant cardiovascular disease including, but not limited to, a history of
             myocardial infarction, coronary angioplasty or bypass graft, unstable angina pectoris,
             transient ischemic attacks, clinically significant abnormal ECGs, New York Heart
             Association (NYHA) Functional Classification III or IV, or documented cerebrovascular
             accident within 6 months prior to Day -1.

         16. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol
             abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per
             day) within 1 year prior to the Screening Visit.

         17. Has used any tobacco (ie, nicotine) products (including but not limited to cigarettes,
             pipe, cigar, chewing tobacco, nicotine patch, or nicotine gum) within 6 months prior
             to Day -1 or is unwilling to abstain from these products for the duration of the study
             or has a positive carbon monoxide test result at Screening or Day -1.

         18. Has taken any medications, supplements or food products as described in the Excluded
             Medications section. A subject has a positive carbon monoxide test result on Day-1.

         19. Has poor peripheral venous access.

         20. Is unwilling or unable to comply with the protocol or scheduled appointments

         21. Is unable to understand verbal and/or written English.

         22. Is a study site employee, or is an immediate family member (ie, spouse, parent, child,
             and sibling) of a study site employee, involved in conduct of this study.

         23. Has received or donated more than 400 mL of blood or blood products within the 45 days
             preceding the beginning of the study or plans to donate blood during the study.