A Study to Assess the Relative Bioavailability of New Oral Formulations of SRT2104 in Healthy Male Volunteers
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, controlled, single center study to assess the safety,
      variability in exposure, and relative bioavailability of new oral formulations of SRT2104.
      This is a two part study and each part consists of screening (within 21 days of the first
      scheduled dose of SRT2104), treatment period and follow-up visit (approximately 6 days after
      the last dose). Part 1: Subjects will receive all four fomulations of SRT2104 and their order
      of their doses will be randomized. Each subject will receive one formulation as a 500
      milligram (mg) dose (in the form of two 250 mg capsules or tablets) in each session given in
      the fasted state. Each dose will be separated by at least 6 days. Pharmacokinetic (PK)
      sampling will be done pre and post each scheduled dosing session. After all 4 dosing
      sessions, the safety and PK data will be reviewed to determine which, if any, formulation(s)
      will be carried forward into Part 2. The total duration will be approximately 7 weeks. Part
      2: Is further divided into Part 2A, 2B and 2C of the study and are optional. After the
      completion of Part 1, the sponsor will decide whether to proceed with any or all of Part 2,
      and whether the selected formulation(s) is to be administered in the fed or fasted state for
      Parts 2B and 2C. For all the sub parts of Part 2 the pre and post-dose PK samples will be
      obtained. Part 2A: A single-dose of the selected formulation(s) from Part 1 will be
      administered after a standard meal to assess the effect of food on the bioavailability of
      SRT2104 at the 500 mg dose. The total duration will be approximately 4 weeks. Part 2B: A
      single alternative dose (other than 500 mg, but not to exceed 2000 mg) of the selected
      formulation(s) from Part 1 will be administered to assess the safety and PK profile of this
      dose level. The total duration will be approximately 4 weeks. Part 2C: The selected
      formulation(s) from Part 1 will be administered at the 500 mg dose once daily for 7
      consecutive days, to assess the safety and tolerability and characterize the PK profile of
      repeat dosing. The total duration will be approximately 5 weeks.
    


Intervention name(s): Cap SRT2104; Tab SRT2104 slow release; Tab SRT2104 intermediate release; Tab SRT2104 fast release; Selected formulations of SRT2104 from Part 1; Selected formulations of SRT2104 from Part 1 single alternative dose
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Micronized free base in a 250 mg SRT2104 (active equivalents) capsule; New 250 mg SRT2104 mesylate salt slow release tablet; New 250 mg SRT2104 mesylate salt intermediate release tablet; New 250 mg SRT2104 mesylate salt fast release tablet; SRT2104 500 mg of selected formulation(s) from Part 1 in single-dose or daily for 7 days; SRT2104 single alternative dose (other than 500 mg, but not to exceed 2000 mg) of selected formulation(s) from Part 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: SRT2104; Modified Release; Bioavailability; Crossover