A Phase 1 Study to Evaluate the Effects of Fluconazole and Atorvastatin on the Pharmacokinetics of TAK-385 in Healthy Subjects
Condition: Prostate Cancer; Endometriosis
MeSH terms: Endometriosis
Intervention: TAK-385; Fluconazole; Atorvastatin
Intervention description: TAK-385 tablets; Fluconazole tablets; Atorvastatin tablets
Intervention MeSH terms: Fluconazole; Atorvastatin; Relugolix
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a nonrandomized, open-label, fixed-sequence, 2-arm study designed to assess the
      effect of multiple doses of fluconazole or atorvastatin on the single-dose pharmacokinetics
      of TAK-385 in healthy adult subjects.
    

Eligibility criteria:

        Inclusion Criteria

        Each subject must meet all the following inclusion criteria to be enrolled in the study:

          1. Age 18 to 55 years, inclusive, at the time of consent.

          2. Healthy adult male or female in good health, as determined by a physician evaluation

          3. Weight ≥ 45 kg and body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at
             screening.

          4. Nonsmoker and does not use tobacco-containing products (including, but not limited to,
             cigarettes, pipes, cigars, chewing tobacco, or nicotine patch or gum).

        Exclusion Criteria Subjects meeting any of the following exclusion criteria are not to be
        enrolled in the study.

          1. The subject has a history of drug abuse (defined as any illicit drug use) within 1
             year before screening or is unwilling to abstain from drugs throughout the study.

          2. The subject is unwilling to agree to abstain from caffeine and alcohol-containing
             products from 72 hours before check-in (Day -1) to completion of the final assessment.

          3. The subject 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).

          4. The subject has taken any over the counter (OTC) medications or vitamin supplements
             within 14 days before check-in (Day -1). The subject is unwilling to agree to abstain
             from consumption of grapefruit or grapefruit-containing products from 72 hours before
             check-in (Day -1) to completion of the final assessment.

          5. The subject has current or recent (within 6 months) history of gastrointestinal
             disease that would be expected to influence the absorption of drugs.

          6. The subject has a positive test result for hepatitis B surface antigen, hepatitis C
             virus (HCV) antibody, human immunodeficiency virus (HIV) antibody or antigen, or
             serological reactions for syphilis at screening.

          7. The subject has a clinically significant ECG abnormality at screening or check-in (Day
             -1) or a QTc interval (by Fridericia's correction) of 450 msec or greater, or the
             subject has a history of cardiac disease.

          8. The subject has abnormal laboratory values suggesting a clinically significant disease
             at screening or check-in (Day -1) .

          9. Female subjects who are lactating and breastfeeding or pregnant before the first dose
             of study drug.

         10. Any serious medical or psychiatric illness that could, in the investigator's opinion,
             potentially interfere with the completion of treatment according to this protocol.