A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bioequivalence of isavuconazole following a
      single dose of isavuconazonium sulfate intravenous (IV) solution via nasogastric (NG) tube
      (test formulation) compared to a single dose of isavuconazonium sulfate capsules for oral
      administration (i.e., oral capsules administered to nonintubated participants)(reference
      formulation). In addition, this study will evaluate the safety and tolerability of
      isavuconazole and the general pharmacokinetic (PK) parameters of isavuconazole when
      administered as a single dose of isavuconazonium sulfate IV solution via NG tube (test
      formulation) and a single dose of isavuconazonium sulfate capsules for oral administration
      (i.e., oral capsules administered to nonintubated participants) (reference formulation) under
      fasting conditions in healthy male and female participants.
    

Detailed description: 
      Eligible participants will participate in 2 treatment periods separated by a washout of at
      least 30 days between investigational product (IP) administrations in each period.
      Participants will be randomized to 1 of 2 sequences. Participants will be admitted to the
      clinical unit on day -1 of each period and will be residential for 5 days/4 nights.
      Participants will receive a single dose of isavuconazonium sulfate IV solution via NG tube
      (test formulation) or isavuconazonium sulfate capsules for oral administration (i.e., oral
      capsules administered to nonintubated participants) (reference formulation) under fasting
      conditions on day 1 of each period. Participants are to remain semirecumbent and avoid lying
      on either the left or right side for 4 hours postdose. Correct placement of the NG tube will
      be confirmed using X-ray radiography. Pharmacokinetic samples will be collected predose on
      day 1 of each period and at multiple time points postdose. Standard safety and tolerability
      assessments will be conducted. Participants will be discharged from the clinical unit on day
      4 of each period on the condition that all required assessments have been performed and that
      there are no medical reasons for a longer stay in the clinical unit. Participants will return
      for ambulatory visits to collect pharmacokinetic samples on days 8, 11, 15 and 21 of each
      period.

      The study will be completed with an end-of-study visit (ESV). The ESV will take place 5 to 9
      days after day 21 of period 2 or at early discontinuation from the study.
    

Intervention name(s): Isavuconazonium sulfate IV; Isavuconazonium sulfate capsules
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous (IV) via nasogastric (NG) tube; Oral
Other intervention name(s): Cresemba; Cresemba
Intervention MeSH terms: Isavuconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cresemba; isavuconazonium sulfate; isavuconazole