Pharmacokinetics Of Orally Administered Fx-1006A In Subjects With Hepatic Dysfunction
Condition: Mild Hepatic Dysfunction; Moderate Hepatic Dysfunction
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, open-label, single-dose study designed to assess the effects of hepatic
      dysfunction on the PK of orally administered Fx-1006A 20 mg soft gelatin capsules.

      An adaptive 2-stage study design will be implemented. Initially (Stage 1), a group of 9
      subjects with moderate hepatic dysfunction (Child-Pugh score of 7-9, inclusive) followed by a
      group of 9 healthy volunteer subjects with normal hepatic function who are comparable in age,
      gender, and weight to the hepatically impaired subjects will be enrolled to receive a single
      oral 20 mg dose of Fx-1006A each.

      Data obtained from the first 2 groups will be analyzed and reviewed by the Sponsor to
      determine whether Fx-1006A PK is altered by hepatic dysfunction. If it is determined that
      hepatic dysfunction affects Fx-1006A PK, then Stage 2 will be commenced. During Stage 2, a
      group of 9 subjects with mild impairment (Child-Pugh score of 5-6, inclusive) will be
      enrolled to receive a single oral 20 mg dose of Fx-1006A each. Additional subjects with
      normal hepatic function may be enrolled to ensure appropriate demographic matching to the
      mild hepatically impaired subjects, with respect to age, gender, and weight.

      During Screening, subjects will provide written informed consent to participate in the study
      and be reviewed against the study entrance criteria (including assessment of hepatic
      function) to determine eligibility. All subjects will provide blood and urine samples for
      clinical laboratory testing, drug testing, and pregnancy testing to determine eligibility.

      Subjects who meet the entrance criteria during Screening will check in to the clinical site 1
      day prior to dosing (Day 0) in the evening, and will be reviewed against the entrance
      criteria to confirm eligibility. Subjects will remain inpatient overnight for pre-dose
      assessments. Subjects will be fasted for a minimum of 8 hours prior to dosing the following
      day (water is allowed).

      The single Fx-1006A dose will be administered on Day 1 under supervision of the Investigator
      or appropriate clinical site staff. Subjects will remain fasted for 4 hours after dosing
      (water is allowed) and will remain inpatient overnight for safety monitoring and PK sample
      collection.

      Subjects will be discharged on Day 2, after they have completed the study procedures and the
      Investigator has determined that the subject is clinically stable. Subjects will return to
      the clinical site for out-patient visits on Days 3, 4, 6, 9, 12, and 16 for safety
      evaluations and PK sample collection. Day 16 will be the end of study visit.
    


Intervention name(s): Fx-1006A; Fx-1006A
Intervention type(s): Drug; Drug
Intervention description(s): A single oral 20 mg dose of Fx-1006A will be administered on Day 1 followed by 16 days of follow-up.; A single oral 20 mg dose of Fx-1006A will be administered on Day 1 followed by 16 days of follow-up.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science