Bioavailability and Effect of Food on TAK-385 Tablet Formulations in Healthy Participants
Condition: Healthy Volunteers
Intervention: TAK-385 T2 Formulation; TAK-385 T4 Formulation B; TAK-385 T4 Formulation C
Intervention description: TAK-385 T2 Formulation tablets; TAK-385 T4 Formulation B tablets; TAK-385 T4 Formulation C tablets
Intervention MeSH terms: Relugolix
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to evaluate the oral bioavailability of two new tablet
      formulations of TAK-385 (T4 Formulation B and T4 Formulation C) under fasted and fed
      conditions, relative the T2 Formulation tablet; and to estimate the effect of food on the
      pharmacokinetics (PK) of a single oral dose of the T4 Formulation B tablet and the T4
      Formulation C tablet.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 to 55 years, inclusive, at the time of consent.

          2. Healthy adult male, as determined by a physician evaluation that includes:

               -  Medical history (ie, no clinically significant medical conditions requiring
                  ongoing drug therapy).

               -  Physical examination.

               -  Vital signs.

               -  Electrocardiogram (ECG).

               -  Laboratory evaluation (hematology, biochemistry, and urinalysis).

               -  No acute illness within 30 days before screening that required prescription or
                  over-the-counter (OTC) medicines.

          3. Weight ≥ 55 kg and body mass index (BMI) between 18.0 and 32.0 kg/m^2 inclusive, at
             Screening.

          4. Nonsmoker for at least 2 years and does not use nicotine-containing products
             (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, or
             nicotine patch or gum).

          5. Male participants, even if surgically sterilized (ie, status postvasectomy), who:

               -  Agree to practice effective barrier contraception during the entire study
                  treatment period and through 4 months after the last dose of study drug, or

               -  Agree to practice true abstinence, when this is in line with the preferred and
                  usual lifestyle of the participant. (Periodic abstinence [eg, calendar,
                  ovulation, symptothermal, postovulation methods for the female partner] and
                  withdrawal are not acceptable methods of contraception.)

          6. Voluntary written consent must be given before performance of any study-related
             procedure not part of standard medical care, with the understanding that consent may
             be withdrawn by the participant at any time without prejudice to future medical care.

          7. Suitable venous access for the study-required blood sampling.

          8. Abstains from behavior that increases susceptibility to contract blood-borne pathogens
             (eg, obtaining a tattoo or participating in unsafe needle use for any purpose) during
             the 28 days before study entry.

          9. In the opinion of the investigator, the participant or legal guardian is capable of
             understanding and complying with protocol requirements.

        Exclusion Criteria:

          1. Has any serious medical or psychiatric illness that could, in the investigator's
             opinion, potentially interfere with the completion of treatment according to this
             protocol.

          2. Has received any investigational compound within 30 days (or 5 half- lives of the
             compound, if longer) before check-in (Day -1).

          3. Has received TAK-385 in a previous clinical study.

          4. 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).

          5. Is lactose intolerant.

          6. 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 before screening or is unwilling to agree to abstain from alcohol
             and drugs throughout the study.

          7. Has a positive test result for hepatitis B surface antigen (HBsAG) or hepatitis C
             virus (HCV) antibody at Screening.

          8. Has a positive urine drug result for drugs of abuse or alcohol at Screening or
             check-in (Day -1).

          9. Has taken any prescription medicine or herbal preparations (eg, St. John's wort) or
             received any immunizations within 30 days before check-in (Day -1).

         10. Has taken any OTC medications or vitamin supplements within 14 days before check-in
             (Day -1). Excluded from this list is occasional use of acetaminophen (paracetamol) ≤ 1
             g/day or other medication approved by the sponsor on a case-by-case basis.

         11. Is unwilling to agree to abstain from caffeine and food products from 72 hours before
             check-in (Day -1) to completion of the study.

         12. Has a clinically significant electrocardiogram (ECG) abnormality at Screening or
             check-in (Day -1) or a QTc interval (by the Fridericia correction) of 450 msec or
             greater. The participant has a history of cardiac disease including, but not limited
             to, congenital long-QT syndrome, torsades de pointes or torsades de pointes risk
             factors (eg, cardiac insufficiency, hypokalemia, family history of long-QT syndrome,
             current use of Class IA [eg, quinidine or procainamide] or Class III [eg, amiodarone
             or sotalol] antiarrhythmic medications or other medications with known effects on QT
             interval).

         13. Has abnormal laboratory values suggesting a clinically significant disease at
             Screening or check-in (Day -1) or has abnormalities in the following laboratory
             parameters: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)
             value >1.5 times the upper limit of normal.

         14. Has engaged in heavy exercise (marathon running, weight lifting, etc) within 72 hours
             before check-in (Day -1) or is unwilling to agree to abstain from heavy exercise
             throughout the study.

         15. Has known allergy to TAK-385 or its excipients.

         16. Participants who, for any reason, are deemed by the investigator to be inappropriate
             for this study, including participants who are unable to communicate or to cooperate
             with the investigator.

         17. Any participant who is an immediate family member, investigational site employee, or
             in a dependent relationship with an investigational site employee who is involved in
             conduct of this study (eg, spouse, parent, child, sibling) or may consent under
             duress.