Studying Different Formulations of SR13668 in Healthy Volunteers
Condition: Healthy, no Evidence of Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized early phase I trial is studying different formulations of SR13668 in healthy
      volunteers. Giving SR13668 may help doctors learn more about how SR13668 is used by the body.
      It is not yet known which formulation of SR13668 is most effectively used by the body.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Determine which oral formulation of Akt inhibitor SR13668 provides the best
      bioavailability in normal, healthy volunteers.

      SECONDARY OBJECTIVES:

      I. Determine the oral pharmacokinetics of a single, low dose of Akt inhibitor SR13668 in
      healthy volunteers.

      II. Characterize the metabolism of Akt inhibitor SR13668 in healthy volunteers. III. Collect
      preliminary safety data for Akt inhibitor SR13668 in healthy volunteers.

      OUTLINE:

      STAGE 1 (for the first 6 participants enrolled in the study [closed to accrual as of August,
      2009]): Participants are randomized to 1 of 2 arms.

      ARM I: Participants complete an overnight fast of ≥ 10 hours, eat a high-fat (approximately
      50% of total caloric content of the meal) and high-calorie (approximately 800-1,000
      calories), and then receive a single dose of oral SR13668 in a PEG400/Labrasol® liquid
      formulation with 8 ounces of water. Participants may not eat for ≥ 4 hours after study drug
      administration.

      ARM II: Participants complete an overnight fast of ≥ 10 hours and then receive a single dose
      of oral SR13668 in a PEG400/Labrasol® liquid formulation with 8 ounces of water. Participants
      may not eat for ≥ 4 hours after study drug administration.

      STAGE 2 (for the next 12 participants enrolled in the study): The preferred dietary condition
      (Arm I) identified in stage 1 is used. Participants are randomized to 1 of 4 arms.

      ARM III: Participants receive a single dose of oral Akt inhibitor SR13668 in a Solutol®
      self-emulsifying solid dispersion capsule formulation.

      ARM IV: Participants receive a single dose of oral Akt inhibitor SR13668 in a
      Solutol®/vitamin E TGPS self-emulsifying solid dispersion capsule formulation.

      ARM V: Participants receive a single dose of oral Akt inhibitor SR13668 in a vitamin E TGPS
      self-emulsifying solid dispersion capsule formulation.

      ARM VI: Participants receive a single dose of oral Akt inhibitor SR13668 in a Myrj 53
      self-emulsifying solid dispersion capsule formulation.

      Blood and urine samples are collected at baseline and periodically during the 24 hours after
      study drug administration for pharmacokinetic analysis by high performance liquid
      chromatography assay.

      After completion of study treatment, participants are followed by telephone at 7-10 days and
      at 30 days.
    

Intervention name(s): Akt inhibitor SR13668
Intervention type(s): Drug
Intervention description(s): Given orally as a single dose
Other intervention name(s): SRI13668
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment