CG-549 Tablet Pharmacokinetics Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an open label, crossover, single dose study consisting of 2 parts (Part A and
      Part B) in a total of 24 healthy male and female subjects.
    

Detailed description: 
      Part A Part A is an open-label, 3-period, fixed-sequence, escalating dose study in 6 healthy
      subjects to find a tablet dose that results in a CG-549 exposure that is expected to be safe
      and potentially efficacious (i.e., within the targeted efficacious exposure range as defined
      below).

      Subjects will receive the following treatments of the tablet formulation of CG-549, in the
      fed state:

        -  Period 1: a single oral dose of 300 mg CG-549 on Day 1.

        -  Period 2: a single oral dose of XX mg CG-549 on Day 1. After interim PK evaluation of
           Period 1, the CG-549 dose of Period 2 will aim at reaching the lower end of the targeted
           efficacious exposure range.

        -  Period 3: a single oral dose of YY mg CG-549 on Day 1. After interim PK evaluation of
           Period 2, the CG-549 tablet dose of Period 3 will aim at reaching the higher end of the
           targeted efficacious exposure range.

      Doses XX and YY will be multiples of 300 mg and will not exceed 3 times the dose used in the
      preceding period.

      After interim PK evaluation of all periods in Part A, the CG-549 dose and the type of
      breakfast to be used in Part B will be selected which is anticipated to result in an exposure
      that is expected to be safe and potentially efficacious.

      Part B Part B is an open-label, 2-period, randomized crossover study in 18 healthy subjects
      to confirm that the selected dose of the tablet formulation of CG-549 results in a CG-549
      exposure that is expected to be safe and potentially efficacious, and to compare the PK
      profiles of a single dose of the tablet formulation of CG 549 between the fed and the fasted
      states.

      Subjects will receive the following treatments of the tablet formulation of CG-549:

        -  Period 1: a single oral dose of ZZ mg CG-549 on Day 1 in fed or fasted state.

        -  Period 2: a single oral dose of ZZ mg CG-549 on Day 1 in fasted or fed state. Dose ZZ
           will be a multiple of 300 mg.

      There will be 2 treatment sequences in the study: fed-fasted and fasted-fed. Subjects will be
      randomly assigned to a treatment sequence in a 1:1 ratio. In the fed state, subjects will
      either receive a high-fat or a medium fat breakfast.
    

Intervention name(s): CG-549
Intervention type(s): Drug
Intervention description(s): PART A (open-label)
Period 1: single oral dose. Period 2: After PK evaluation of period 1. Period 3: After PK evaluation of period 2.
PART B (randomized)
Period 1: a single oral dose of ZZ mg CG-549 on Day 1 in fed or fasted state.
Period 2: a single oral dose of ZZ mg CG-549 on Day 1 in fasted or fed state.
Other intervention name(s): PART A and PART B
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized cross-over study
Masking: None (Open Label)
Primary purpose: Treatment