A Clinical Study to Assess the Effect of Food and Gender on the Pharmacokinetics of SRT2104 Administered as an Oral Suspension or Capsule Formulation to Normal Healthy Volunteers
The primary objective of this study is to assess the pharmacokinetic profile of a single 500 mg dose of SRT2104 administered as an oral suspension and a capsule formulation to normal healthy male and female volunteers in both the fed and fasted state.
The secondary objective is to assess the safety and tolerance of SRT2104 administered as an oral suspension and as a capsule formulation to healthy male and female volunteers in both the fed and fasted state.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||A Phase I Randomized, Open-label, Clinical Study to Assess the Effect of Food and Gender on the Pharmacokinetics of SRT2104 Administered as an Oral Suspension or Capsule Formulation to Normal Healthy Volunteers|
- Characterize and compare the pharmacokinetic profile of a single 500 mg dose of SRT2104 administered as an oral suspension and as a capsule formulation. [ Time Frame: PK time points: pre-dose (0 hrs); 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0. 6.0, 8.0, 10, 12, 15, 24, 36, 48, 72 hours post dose. ]
- Assess the safety and tolerance of SRT2104. [ Time Frame: AEs, concomitant medications (as applicable), vital signs, physical examinations, laboratory parameters, and ECG parameters will be collected for the duration of the study. ]
|Study Start Date:||January 2009|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Experimental: 0.5g SRT2104
Cohort 1 (10 males) & Cohort 2 (10 females) must attend the clinic on 4 separate treatment visits during the study; each treatment visit will be one week apart. At each treatment visit, subjects will receive one of the following 4 treatments:
A) 0.5g SRT2104 administered as an oral suspension in the fasted state B) 0.5g SRT2104 administered as an oral suspension following consumption of a standard meal C) 0.5g SRT2104 administered as two 0.25g capsules in the fasted state D) 0.5g SRT2104 administered as two 0.25g capsules following consumption of a standard meal.
For treatments A and C, subjects will have fasted for at least 10 hours overnight. Water will be restricted from 1h prior to dosing until 1h post dose. A light lunch will be provided 4h post dose. For treatments B and D, subjects will receive SRT2104 within 30 min following the start of consumption of a standardized non high-fat meal (approximately 650 kcal with approximately 30% of calories derived from fat).
Drug: 0.5g SRT2104
SRT2104 will be supplied in two forms: as 0.5g powder which will be prepared by the pharmacist/designee into a liquid suspension and as two hard gelatin capsules, each containing 0.25g SRT2104. The dosing vehicle for the liquid suspension is 1% (by weight) hypromellose acetate succinate in water, which is used as a suspension aid and a dispersant for the SRT2104.
Each formulation of test material will be administered orally, in a single dose to the subjects in the fasted state and following consumption of a standard meal. Neither the investigator nor the subjects enrolled will be blinded to treatment assignment.
|GSK Investigational Site|
|Merthyr Tydfill, Glamorgan, United Kingdom, CF48 4DR|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|