Clinical Study to Assess the Pharmacokinetics, Safety and Tolerability of SRT2104 Administered to Normal Healthy Male Volunteers
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetic profile, safety, and tolerability
      of SRT2104 following administration of single and multiple oral doses (once a day for seven
      days) at a single dose level (2.0 g/day) to healthy male volunteers in the fed state.
    

Detailed description: 
      This is a prospective, single center, clinical study of SRT2104 administered orally; a
      randomized, inpatient/outpatient study to assess the safety and pharmacokinetics (PK) of
      SRT2104 in healthy male volunteers. Ten (10) male subjects, aged 18-60, who fulfil the
      inclusion/exclusion criteria, will be enrolled in this study. Subjects will receive either a
      dose of 2.0 g SRT2104 (administered as eight 250 mg capsules) or placebo on eight occasions
      during the study; once as a single dose (study day 1) during Treatment Period 1, and once per
      day for seven consecutive days (study days 15 to 21) during Treatment Period 2. Every
      administration of SRT2104 will be in the fed state (i.e. within 30 minutes following the
      start of consumption of a standard meal).

      Subjects will be asked to sign the informed consent form at the screening visit. If eligible
      and willing to participate, subjects will enter into the study. Subjects will be required to
      attend the research unit on eight separate occasions during the study, in addition to the
      screening visit. Treatment Period 1 requires the subject to attend the unit for two
      consecutive overnight stays (Day -1 and Day 1), after which subjects will be discharged from
      the unit on Day 2 (following the 24 hr post-dose PK blood sample). Subjects will then be
      required to return to the unit for PK blood samples to be obtained on Day 3 (48 hr
      post-dose), Day 4 (72 hr post-dose) and Day 8 (168 hr post-dose). Following a washout period
      of seven days, subjects will be required to attend the unit for Treatment Period 2, which
      will involve eight consecutive overnight stays (Days 14 to 21), after which subjects will be
      discharged from the unit on Day 22 (following the 24 hr post-dose PK blood sample). Subjects
      will then be required to return to the unit for PK blood samples to be obtained on Day 23 (48
      hr post-dose), Day 24 (72 hr post-dose) and Day 28 (168 hr post-dose).

      Subjects will be randomised 8:2 (active:placebo) to receive one of the following two
      treatments for the duration of the study:

      A. 2.0 g SRT2104 administered as eight 250 mg hard gelatin capsules B. Eight placebo capsules

      Water will be restricted from 1 hour prior to dosing until 1 hour post-dose. Subjects will
      receive SRT2104 within 30 minutes following the start of consumption of a standardized
      non-high-fat meal (approximately 650 kcal with approximately 30% of calories derived from
      fat). A light lunch will be provided 4 hours post-dose, an evening meal approximately 8 hours
      post dose and a snack approximately 12 hours post dose.

      Subjects will be discharged from the study on Day 28 after the 168 h PK sample has been
      obtained, all required safety assessments have been performed, and the subject has been
      confirmed clinically stable by the investigator/identified sub-investigator.
    

Intervention name(s): SRT2104; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2.0 g of SRT2104 will be supplied in hard gelatin capsules each containing 250 mg SRT2104. SRT2104 will be administered within 30 minutes following the start of consumption of a standardized non-high-fat meal (approximately 650 kcal with approximately 30% of calories derived from fat). The eight capsules of SRT2104 will be orally-administered with approximately 200 mL water.; Placebo will be supplied in hard gelatine capsules containing an appropriate amount of placebo. Placebo will be administered within 30 minutes following the start of consumption of a standardized non-high-fat meal (approximately 650 kcal with approximately 30% of calories derived from fat). The eight capsules of placebo will be orally-administered with approximately 200 mL water.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science