Clinical Pharmacology Study of AZD7295 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetic profile of oral doses of
      AZD7295 capsules in healthy subjects, and also to assess the effects of food as well as
      safety and tolerability.
    

Detailed description: 
      OBJECTIVES: Primary

        -  To determine the pharmacokinetic profiles of oral doses of AZD7295 capsules administered
           to healthy subjects

        -  To study the effect of food on the pharmacokinetic profiles of oral doses of AZD7295
           capsules in healthy subjects

        -  To assess the safety and tolerability profiles of oral daily doses of AZD7295 capsules
           in healthy subjects TYPE AND DESIGN: Part A A phase I, single-centre, double-blind,
           randomised, placebo-controlled, crossover, food effect study in healthy subjects

      Part B A phase I, single-centre, double-blind, randomised, placebo-controlled, ascending dose
      study in healthy subjects

      NUMBER OF SUBJECTS: 16 subjects will take part in a total of 4 treatment periods.

      SUBJECT CHARACTERISTICS: Healthy males and females of non-child bearing potential aged 18 to
      65 years.

      Recruitment will not be balanced for gender or any other variable.

      TREATMENT: Part A

      Subjects will be randomised to receive AZD7295 or placebo (14 active; 2 placebo) in either
      the fed or fasted state according to the treatment allocation:

      Treatment A: 260 mg (4 x 65 mg) AZD7295 capsules or placebo dosed in the fed state

      Treatment B: 260 mg (4 x 65 mg) AZD7295 capsules or placebo dosed in the fasted state

      Following dosing of the first two periods there will be a period of interim analysis, during
      which the pharmacokinetic data will be reviewed in order to determine whether the remaining
      treatments will be dosed either in the fed or fasted state.

      Subjects from Part A will continue into Part B of the study.

      Part B

      Subjects will be allocated to two groups of n=8 (Group 1 and Group 2) and randomised to
      receive AZD7295 or placebo (6 active; 2 placebo). Subjects will receive two of the ascending
      dose treatments in the following order according to group allocation:

      Group 1:

      Treatment C: 455 mg (7 x 65 mg) AZD7295 or placebo dosed either in the fed or fasted state;

      Group 2:

      Treatment D: 650 mg (10 x 65 mg) AZD7295 or placebo dosed either in the fed or fasted state;

      Group 1:

      Treatment E: 650 mg (10 x 65 mg) AZD7295 or placebo, twice a day (q12h) dosed either in the
      fed or fasted state (total administered dose: 1300 mg);

      Group 2:

      Treatment F: 650 mg (10 x 65 mg) AZD7295 or placebo, three times a day (q8h) dosed either in
      the fed or fasted state (total administered dose: 1950 mg).

      Safety data and limited PK data will be reviewed by the data review group prior to proceeding
      to the next dose level.

      During the dose escalation phase a maximum of 4 subjects will be dosed per day.

      MAIN OUTCOME MEASURES: The primary outcome will be to determine the pharmacokinetic profiles
      of AZD7295 when dosed in the fed and fasted state and to assess the safety and tolerability
      of higher daily doses of AZD7295.

      GENERAL SCHEDULE: Screening is planned to start in April 2009, with the clinical phase due to
      be completed by the end of July 2009
    

Intervention name(s): AZD7295; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules 260mg, 455mg, 650mg (single doses), 650mg q12h, 650mg q8h.; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Hepatitis C; Pharmacokinetics; AZD7295; Healthy volunteers