Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First patient enrolled: 11 June 2008. Last patient completed: 09 October 2008. Single-centre study performed at a Clinical Pharmacology Unit

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None

Reporting Groups

	Description
AZD9668	AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
Placebo	Matched placebo tablets twice daily (bid) for 14 days

Participant Flow:   Overall Study

	AZD9668	Placebo
STARTED	12	6
COMPLETED	12	6
NOT COMPLETED	0	0

Reporting Groups

	Description
AZD9668	AZD9668 2x30mg oral tablets twice daily (bid) for 14 days
Placebo	Matched placebo tablets twice daily (bid) for 14 days

Baseline Measures

	AZD9668	Placebo	Total
Number of Participants   [units: participants]	12	6	18
Age   [units: Years] Mean ( Full Range )	57.6     ( 42 to 70 )	52.8     ( 44 to 65 )	56     ( 42 to 70 )
Gender   [units: Participants]
Female	3	2	5
Male	9	4	13

1.  Primary:

Alanine Aminotransferase (ALT)   [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ]

2.  Primary:

Aspartate Aminotransferase (AST)   [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ]

3.  Primary:

Creatine Kinase (CK)   [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ]

4.  Primary:

Total Bilirubin   [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ]

5.  Primary:

Creatinine   [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ]

6.  Primary:

Haemoglobin (Hb)   [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ]

7.  Primary:

Reticulocytes   [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ]

8.  Primary:

Leucocytes   [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ]

9.  Primary:

QTcF (QT Interval Corrected for Heart Rate by Fridericia’s Method)   [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ]

10.  Primary:

QTcF   [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ]

11.  Primary:

FEV1 (Forced Expiratory Volume in the First Second)   [ Time Frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose) ]

12.  Primary:

Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post-dose (AUC(0-12))   [ Time Frame: Pre-dose on day -1 to day 15 (end of dosing) ]

13.  Primary:

Observed Peak or Maximum Plasma Concentration Following Drug Administration (Cmax)   [ Time Frame: Pre-dose on day -1 to day 15 (end of dosing) ]

14.  Primary:

Time to Reach Observed Peak or Maximum Concentration Following Oral Drug Administration (Tmax)   [ Time Frame: Pre-dose on day -1 to day 15 (end of dosing) ]

15.  Primary:

Terminal Half-life of Drug in Plasma (t1/2)   [ Time Frame: Pre-dose on day -1 to day 15 (end of dosing) ]

16.  Primary:

Renal Clearance of Drug From Plasma (CLR)   [ Time Frame: Pre-dose on day -1 to day 15 (end of dosing) ]

17.  Secondary:

Sputum Absolute Neutrophil Count   [ Time Frame: Pre-dose day -1 to post-dose on day 14 ]

18.  Secondary:

Sputum Differential Neutrophil Count   [ Time Frame: Pre-dose day -1 to post-dose on day 14 ]

19.  Secondary:

AZD9668 Sputum Concentrations   [ Time Frame: Pre-dose day -1 to post-dose on day 14 ]

20.  Secondary:

Quantitative Sputum Bacteriology   [ Time Frame: Pre-dose day -1 to post-dose on day 15 ]