A Study to Evaluate Drug-Drug Interaction of TAK-788 With Itraconazole and Rifampin in Healthy Adult Participants
Condition: Healthy Volunteers
Intervention: TAK-788; Itraconazole; Rifampin
Intervention description: TAK-788 Capsules; Itraconazole Oral solution; Rifampin Capsules
Intervention MeSH terms: Itraconazole; Rifampin
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to characterize the effect of itraconazole (Part 1) and rifampin
      (Part 2) on the single-dose pharmacokinetics (PK) of TAK-788 and its active metabolites
      (AP32960 and AP32914) in healthy adult participants.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Continuous non smoker who has not used nicotine containing products for at least 3
             months prior to the first dose and throughout the study based on participant
             self-reporting.

          2. Medically healthy with no clinically significant medical history, physical
             examination, laboratory profiles, vital signs, or electrocardiograms (ECGs), as deemed
             by the Investigator or designee. Has liver function tests (LFTs) including alanine
             aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP),
             and total bilirubin within the upper limit of normal at screening and at first
             check-in.

          3. Normal baseline spirometry for forced vital capacity (FVC) and forced expiratory
             volume (FEV1)/FVC within 7 days prior to the first dosing based on the following
             normal FVC and FEV1/FVC range: a. 20 - 39 years of age: ≥ 80% and b. 40 - 55 years of
             age: ≥ 75%

          4. Body mass index (BMI) ≥18.0 and ≤32.0 kg/m^2, at screening.

        Key Exclusion Criteria:

          1. History or presence of alcoholism or drug abuse within the past 2 years prior to the
             first dosing.

          2. History or presence of hypersensitivity or idiosyncratic reaction to the study drugs
             or related compounds.

          3. Presence of an acute lung infection, within 3 months of screening.

          4. History or presence of any previous lung disease.

          5. Part 1 only: History or presence of any of the following, deemed clinically
             significant by the PI or designee, and as confirmed by the Sponsor:

               -  Ventricular dysfunction or risk factors for Torsades de Pointes (e.g., heart
                  failure, cardiomyopathy, family history of Long QT Syndrome);

               -  Uncorrected hypokalemia (potassium levels <3.7) and/or hypomagnesemia (magnesium
                  levels <1.9);

               -  Myasthenia gravis.

          6. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B
             surface antigen (HBsAg) or hepatitis C virus (HCV).

          7. Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at
             screening.

          8. Seated heart rate is lower than 40 bpm or higher than 99 bpm at screening.

          9. QTcF interval is >460 msec (males) or >470 msec (females) or ECG findings are deemed
             abnormal with clinical significance by the Investigator or designee at screening.

         10. Estimated creatinine clearance <90 mL/min at screening

         11. Unable to refrain from or anticipates the use of:

               -  Any drug, including prescription and non-prescription medications, herbal
                  remedies, or vitamin supplements within 14 days prior to the first dosing and
                  throughout the study. Medication listed as part of acceptable birth control
                  methods will be allowed. Thyroid hormone replacement medication may be permitted
                  if the subject has been on the same stable dose for the immediate 3 months prior
                  to the first dosing. Acetaminophen (up to 2 g per 24 hour period) may be
                  permitted during the study, only after initial dosing.

               -  Any drugs known to be inhibitors or inducers of CYP3A enzymes and/or P-gp,
                  including St. John's Wort, within 28 days prior to the first dosing and
                  throughout the study. Appropriate sources (e.g., Flockhart Table™) will be
                  consulted to confirm lack of pharmacokinetic (PK)/pharmacodynamics interaction
                  with study drugs.