Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-25 @ 8:56 PM
Study NCT ID:
NCT00906256
Status:
COMPLETED
Last Update Posted:
2010-02-12
First Post:
2009-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Pharmacology Study of AZD7295 in Healthy Subjects
Sponsor:
Arrow Therapeutics
Organization:
Study Overview
Official Title:
A Clinical Pharmacology Study to Determine the Pharmacokinetic, Safety and Tolerability Profile of Oral Doses of AZD7295 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
* 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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: