Trial Outcomes & Findings for Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal or Impaired Kidney Function (NCT NCT01894256)

NCT ID: NCT01894256

Last Updated: 2016-10-13

Results Overview

Maximum plasma drug concentration of olaparib

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

56 participants

Primary outcome timeframe

Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Results posted on

2016-10-13

Participant Flow

First patient enrolled: 20 Nov 2013; last completed Part A: 27 Mar 2015. Patients were enrolled at 13 sites in 5 countries. Part A assessed PK of olaparib in patients with mild/moderate renal impairment vs normal renal function; Part B provided additional safety data. Data are presented for Part A and Part B.

56 patients were enrolled into the study, of which 12 did not fulfill the eligibility criteria. Consequently, 44 patients were assigned to treatment and received at least one dose of olaparib in Part A. Forty-three of these 44 patients were assigned treatment and received at least one dose of olaparib in Part B.

Participant milestones

Participant milestones
Measure	Normal Renal Function Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Mild Renal Impairment Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Moderate Renal Impairment Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
Part A STARTED	15	15	14
Part A COMPLETED	15	14	14
Part A NOT COMPLETED	0	1	0
Part B STARTED	15	14	14
Part B COMPLETED	0	0	0
Part B NOT COMPLETED	15	14	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Normal Renal Function Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Mild Renal Impairment Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Moderate Renal Impairment Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
Part A Adverse Event	0	1	0
Part B Death	0	1	1
Part B Withdrawal by Subject	0	1	0
Part B Lack of Efficacy	15	12	13

Baseline Characteristics

Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal or Impaired Kidney Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Normal Renal Function n=15 Participants Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Mild Renal Impairment n=15 Participants Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Moderate Renal Impairment n=14 Participants Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Total n=44 Participants Total of all reporting groups
Age, Continuous	57.1 Years STANDARD_DEVIATION 9.90 • n=5 Participants	63.5 Years STANDARD_DEVIATION 6.92 • n=7 Participants	65.4 Years STANDARD_DEVIATION 12.86 • n=5 Participants	61.9 Years STANDARD_DEVIATION 10.52 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	25 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	19 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	15 Participants n=7 Participants	14 Participants n=5 Participants	43 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	14 Participants n=7 Participants	14 Participants n=5 Participants	43 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Population: PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose. Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded.

Maximum plasma drug concentration of olaparib

Outcome measures

Outcome measures
Measure	Normal Renal Function n=12 Participants Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Mild Renal Impairment n=13 Participants Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Moderate Renal Impairment n=13 Participants Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
Cmax of Olaparib	7.227 μg/mL Geometric Coefficient of Variation 31.0	9.081 μg/mL Geometric Coefficient of Variation 40.6	9.977 μg/mL Geometric Coefficient of Variation 44.2

PRIMARY outcome

Timeframe: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Area under plasma concentration-time curve from zero to infinity of olaparib

Outcome measures

Outcome measures
Measure	Normal Renal Function n=12 Participants Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Mild Renal Impairment n=13 Participants Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Moderate Renal Impairment n=13 Participants Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
AUC of Olaparib	43.70 μg*h/mL Geometric Coefficient of Variation 50.1	70.56 μg*h/mL Geometric Coefficient of Variation 75.6	76.44 μg*h/mL Geometric Coefficient of Variation 78.2

PRIMARY outcome

Timeframe: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Area under plasma concentration-time curve from zero to the last measurable time point of olaparib

Outcome measures

Outcome measures
Measure	Normal Renal Function n=12 Participants Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Mild Renal Impairment n=13 Participants Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Moderate Renal Impairment n=13 Participants Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
AUC0-t of Olaparib	39.97 μg*h/mL Geometric Coefficient of Variation 48.3	62.80 μg*h/mL Geometric Coefficient of Variation 70.3	69.19 μg*h/mL Geometric Coefficient of Variation 71.6

PRIMARY outcome

Timeframe: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Time to reach maximum plasma concentration of olaparib

Outcome measures

Outcome measures
Measure	Normal Renal Function n=12 Participants Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Mild Renal Impairment n=13 Participants Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Moderate Renal Impairment n=13 Participants Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
Tmax of Olaparib	1.99 Hours Interval 1.07 to 3.03	1.55 Hours Interval 1.0 to 3.0	2.00 Hours Interval 1.0 to 3.0

PRIMARY outcome

Timeframe: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Apparent volume of distribution of olaparib

Outcome measures

Outcome measures
Measure	Normal Renal Function n=12 Participants Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Mild Renal Impairment n=13 Participants Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Moderate Renal Impairment n=13 Participants Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
Vz/F of Olaparib	283.4 L Standard Deviation 177.9	131.2 L Standard Deviation 118.9	125.7 L Standard Deviation 167.2

PRIMARY outcome

Timeframe: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Apparent plasma clearance of olaparib

Outcome measures

Outcome measures
Measure	Normal Renal Function n=12 Participants Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Mild Renal Impairment n=13 Participants Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Moderate Renal Impairment n=13 Participants Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
CL/F of Olaparib	7.598 L/hour Standard Deviation 3.649	5.285 L/hour Standard Deviation 3.876	4.788 L/hour Standard Deviation 2.904

PRIMARY outcome

Timeframe: Part A: Day 1, 0-12 hours and 12-24 hours post-dose

Population: Subset of PK analysis set with urine samples available. PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose. Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded.

Renal clearance of olaparib, calculated as the ratio of amount of drug excreted over 24 hours to AUC0-24

Outcome measures

Outcome measures
Measure	Normal Renal Function n=7 Participants Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Mild Renal Impairment n=8 Participants Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Moderate Renal Impairment n=7 Participants Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
CLR of Olaparib	1.4810 L/hour Standard Deviation 0.4848	0.6137 L/hour Standard Deviation 0.2859	0.2989 L/hour Standard Deviation 0.1746

PRIMARY outcome

Timeframe: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose

Terminal half-life of olaparib

Outcome measures

Outcome measures
Measure	Normal Renal Function n=12 Participants Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Mild Renal Impairment n=13 Participants Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Moderate Renal Impairment n=13 Participants Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
t1/2 of Olaparib	24.26 Hours Standard Deviation 9.749	17.45 Hours Standard Deviation 8.035	16.09 Hours Standard Deviation 9.384

OTHER_PRE_SPECIFIED outcome

Timeframe: Part A: Day 1, 1 hour post-dose

Population: Subset of PK analysis set with protein binding blood sample available. PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose. Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded.

Degree to which olaparib binds to the proteins within blood plasma

Outcome measures

Outcome measures
Measure	Normal Renal Function n=13 Participants Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Mild Renal Impairment n=12 Participants Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Moderate Renal Impairment n=14 Participants Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
Protein Binding of Olaparib	7.593 % plasma Standard Deviation 3.447	6.530 % plasma Standard Deviation 2.102	8.022 % plasma Standard Deviation 3.996

OTHER_PRE_SPECIFIED outcome

Timeframe: Part A: Day 1, 1 hour post-dose

Cmax of unbound olaparib; calculated by multiplying total Cmax value by estimated protein binding

Outcome measures

Outcome measures
Measure	Normal Renal Function n=11 Participants Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Mild Renal Impairment n=11 Participants Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Moderate Renal Impairment n=13 Participants Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
Free Cmax of Olaparib	0.4604 μg/mL Geometric Coefficient of Variation 60.0	0.5904 μg/mL Geometric Coefficient of Variation 40.4	0.7296 μg/mL Geometric Coefficient of Variation 37.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Part A: Day 1, 1 hour post-dose

AUC of unbound olaparib; calculated by multiplying total AUC by estimated protein binding

Outcome measures

Outcome measures
Measure	Normal Renal Function n=11 Participants Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Mild Renal Impairment n=11 Participants Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Moderate Renal Impairment n=13 Participants Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
Free AUC of Olaparib	2.819 μg*h/mL Geometric Coefficient of Variation 65.6	4.771 μg*h/mL Geometric Coefficient of Variation 58.5	5.590 μg*h/mL Geometric Coefficient of Variation 52.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Part A: Day 1, 1 hour post-dose

Calculated from dose divided by free AUC

Outcome measures

Outcome measures
Measure	Normal Renal Function n=11 Participants Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Mild Renal Impairment n=11 Participants Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Moderate Renal Impairment n=13 Participants Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
CL/F of Unbound Olaparib	127.7 L/hour Standard Deviation 92.09	71.41 L/hour Standard Deviation 37.40	59.95 L/hour Standard Deviation 29.73

Adverse Events

Part A Normal Renal Function

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Part A Mild Renal Impairment

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Part A Moderate Renal Impairment

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part B Normal Renal Function

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

Part B Mild Renal Impairment

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

Part B Moderate Renal Impairment

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A Normal Renal Function n=15 participants at risk Patients from Part A of the study with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Part A Mild Renal Impairment n=15 participants at risk Patients in Part A of the study with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Part A Moderate Renal Impairment n=14 participants at risk Patients in Part A of the study with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Part B Normal Renal Function n=15 participants at risk Patients in Part B of the study with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Part B Mild Renal Impairment n=14 participants at risk Patient in Part B of the study with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Part B Moderate Renal Impairment n=14 participants at risk Patient in Part B of the study with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
General disorders ASTHENIA	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	6.7% 1/15 • Number of events 1 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	7.1% 1/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	7.1% 1/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	14.3% 2/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	7.1% 1/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	7.1% 1/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Psychiatric disorders CONFUSIONAL STATE	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Gastrointestinal disorders ILEUS	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	7.1% 1/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
General disorders NON CARDIAC CHEST PAIN	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	7.1% 1/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Infections and infestations INFECTION	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	7.1% 1/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Infections and infestations UROSEPSIS	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	7.1% 1/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Metabolism and nutrition disorders HYPONATRAEMIA	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	7.1% 1/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC DEGENERATION	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	7.1% 1/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.

Other adverse events

Other adverse events
Measure	Part A Normal Renal Function n=15 participants at risk Patients from Part A of the study with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Part A Mild Renal Impairment n=15 participants at risk Patients in Part A of the study with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Part A Moderate Renal Impairment n=14 participants at risk Patients in Part A of the study with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Part B Normal Renal Function n=15 participants at risk Patients in Part B of the study with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Part B Mild Renal Impairment n=14 participants at risk Patient in Part B of the study with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).	Part B Moderate Renal Impairment n=14 participants at risk Patient in Part B of the study with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study. Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
Blood and lymphatic system disorders ANAEMIA	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	14.3% 2/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	20.0% 3/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	35.7% 5/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	35.7% 5/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	13.3% 2/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	14.3% 2/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	14.3% 2/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Gastrointestinal disorders CONSTIPATION	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	14.3% 2/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	26.7% 4/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	28.6% 4/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	7.1% 1/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Gastrointestinal disorders NAUSEA	20.0% 3/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	13.3% 2/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	60.0% 9/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	50.0% 7/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	57.1% 8/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Gastrointestinal disorders VOMITING	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	13.3% 2/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	26.7% 4/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	35.7% 5/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	28.6% 4/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
General disorders ASTHENIA	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	7.1% 1/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	13.3% 2/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	14.3% 2/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	21.4% 3/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
General disorders FATIGUE	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	7.1% 1/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	53.3% 8/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	57.1% 8/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	57.1% 8/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
General disorders PYREXIA	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	28.6% 4/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	7.1% 1/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	21.4% 3/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Metabolism and nutrition disorders HYPERGLYCAEMIA	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	14.3% 2/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Metabolism and nutrition disorders HYPONATRAEMIA	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	14.3% 2/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	21.4% 3/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	14.3% 2/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	14.3% 2/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Musculoskeletal and connective tissue disorders ALTHRALGIA	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	14.3% 2/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	7.1% 1/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Nervous system disorders DYSGEUSIA	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	21.4% 3/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	7.1% 1/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Psychiatric disorders CONFUSIONAL STATE	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	7.1% 1/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	14.3% 2/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Renal and urinary disorders DYSURIA	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	13.3% 2/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Renal and urinary disorders RENAL FAILURE	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	14.3% 2/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Respiratory, thoracic and mediastinal disorders COUGH	13.3% 2/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	26.7% 4/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	14.3% 2/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	14.3% 2/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	33.3% 5/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	7.1% 1/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	21.4% 3/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Skin and subcutaneous tissue disorders RASH	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	13.3% 2/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Skin and subcutaneous tissue disorders PRURITUS	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	14.3% 2/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	14.3% 2/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	7.1% 1/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	14.3% 2/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	13.3% 2/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	7.1% 1/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	7.1% 1/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Gastrointestinal disorders DIARRHOEA	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	26.7% 4/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	42.9% 6/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	28.6% 4/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Gastrointestinal disorders DYSPEPSIA	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	14.3% 2/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	14.3% 2/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
General disorders NON CARDIAC CHEST PAIN	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	14.3% 2/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	14.3% 2/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
General disorders ODEMA PERIPHERAL	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	13.3% 2/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	28.6% 4/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	7.1% 1/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Investigations WEIGHT DECREASED	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	7.1% 1/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	21.4% 3/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	20.0% 3/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	35.7% 5/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	35.7% 5/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Metabolism and nutrition disorders HYPERCALCAEMIA	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	13.3% 2/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Metabolism and nutrition disorders HYPERKALAEMIA	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	14.3% 2/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Metabolism and nutrition disorders HYPOKALAEMIA	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	13.3% 2/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	7.1% 1/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CANCER PAIN	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	13.3% 2/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	7.1% 1/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	7.1% 1/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOUR PAIN	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	6.7% 1/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	21.4% 3/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Nervous system disorders HEADACHE	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	20.0% 3/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	14.3% 2/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	21.4% 3/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/15 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	0.00% 0/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.	14.3% 2/14 • AEs were reported with an onset date between the date of first dose in the appropriate Part and the day before first dose in Part B (for Part A), or 30 days following the date of last dose of study medication if the subject discontinued (for Part B). AE data were collected on Days 1-5, and at 30 days following the date of last dose of study medication if the subject discontinued in Part A.

Additional Information

Dr Anitra Fielding

AstraZeneca

Phone: +44 1625 582828

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER