NCT00906256

Clinical Pharmacology Study of AZD7295 in Healthy Subjects

A Clinical Pharmacology Study to Determine the Pharmacokinetic, Safety and Tolerability Profile of Oral Doses of AZD7295 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Arrow Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	AZD7295	Capsules 260mg, 455mg, 650mg (single doses), 650mg q12h, 650mg q8h.
DRUG	Placebo	Placebo

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2009-05-21
• Last updated: 2010-02-12

Locations

1 site across 1 country: United Kingdom