Study to Assess the Safety of AZD1480 in Patients With Myeloproliferative Diseases
Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00910728
Collaborator
University of Texas (Other), New York City Hoffman Center (Other), Gustave Roussy, Cancer Campus, Grand Paris (Other)
65
3
1
63
21.7
0.3
Study Details
Study Description
Brief Summary
This study is being conducted to test study drug AZD1480 to see how it may work to treat myeloproliferative diseases. The main purpose of this study is to determine the safety and tolerability of AZD1480. This is the first time the drug has been given to humans and is classed as a first time in man study. Its main purpose is to establish a safe dosage of the drug and provide additional information on any potential side effects this drug may cause. The study will also assess the blood levels and action of AZD1480 in the body over a period of time and will indicate whether the drug has a therapeutic effect on myeloproliferative diseases.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
65 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A PhaseI/II, Open Label Multi-Centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the JAK2 Inhibitor AZD1480 Administered Orally to Patients With Primary Myelofibrosis (PMF) and Post-Polycythaemia Vera/Essential Thrombocythaemia Myelofibrosis (Post-PV/ET MF
Study Start Date
:
May 1, 2009
Actual Primary Completion Date
:
Mar 1, 2012
Actual Study Completion Date
:
Aug 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 AZD1480 |
Drug: AZD1480
Oral capsule 2.5 mg, 10 mg and 40 mg
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetic Parameters Following Single Dosing: AUC0-12 [0 to 12 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post dose)]
Single dose AUC0-12 (ug*h/L)
- Pharmacokinetic Parameters Following Single Dosing: AUC0-24 [0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)]
Single dose AUC0-24 (ug*h/L)
- Pharmacokinetic Parameters Following Single Dosing:AUC0-inf [0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)]
Single dose AUC(0 to infinity) (ug*h/L)
- Pharmacokinetic Parameters Following Multiple Dosing: Cmax,ss [On Days 1 and 28 at 0, 0,5, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose, and at 0, 2, 4 hours post dose on Days 4 and 10]
Multiple dose Cmax,ss (ug/L)
- Pharmacokinetic Parameters Following Multiple Dosing: Cmin,ss [On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose and at 0, 2, 4 hours post-dose on Days 4 and 10.]
Multiple dose Cmin,ss (ug/L)
- Pharmacokinetic Parameters Following Single Dosing: Cmax [0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)]
Single dose Cmax (ug/L)
- Pharmacokinetic Parameters Following Single Dosing: Vz/F [0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)]
Single dose Vz/F (L)
- Pharmacokinetic Parameters Following Single Dosing: CL/F [0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)]
Single dose CL/F (L/h)
- Pharmacokinetic Parameters Following Multiple Dosing: CLss/F [On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post dose and at 0, 2, 4 hours post-dose]
Multiple dose CLss/F (L/h)
- Pharamcokinetic Parameters Following Single Dosing: Tmax [0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)]
Single dose Tmax (h)
- Pharamcokinetic Parameters Following Multiple Dosing: Tmax,ss [On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose and at 0, 2, 4 hours post-dose on Days 4 and 10]
Multiple dose Tmax,ss (h)
- Inhibition of PSTAT3 (Count) [2hrs and 4 hrs post dose]
PSTAT3 inhinition
Eligibility Criteria
Criteria
Ages Eligible for Study:
25 Years
to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients with myelofibrosis requiring therapy
-
Evidence of post-menopausal status or sterile
-
ECOG Performance Status </=2
Exclusion Criteria:
-
Prior therapy with any JAK2 medications
-
Significant lung disorder or lung disease
-
Previous radiation therapy to chest wall or chest infection requiring antibiotic treatment within 28 days before study screening
-
Eye disease of the cornea
-
Patients requiring oxygen supplementation
-
Ejection fraction <45% (ECHO/MUGA) or significant pulmonary hypertension >40 mm Hg (by Echo/Doppler)
-
Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) <70% predicted or >130% predicted
-
Diffusing capacity of the Lung for Carbon Monoxide (DLCO) corrected for hemoglobin <60% predicted, oxygen saturation <88% at rest or after a 6-minute flat walk, without supplemental oxygen
-
Chest infection requiring antibiotics within 7 days of the first dose of Investigational product.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | New York | New York | United States | |
| 2 | Research Site | Houston | Texas | United States | |
| 3 | Research Site | Villejuif Cedex | France |
Sponsors and Collaborators
- AstraZeneca
- University of Texas
- New York City Hoffman Center
- Gustave Roussy, Cancer Campus, Grand Paris
Investigators
- Principal Investigator: Srdan Verstovsek, MD, MDACC
- Principal Investigator: Ronald Hoffman, MD, Mt. Sinai
- Principal Investigator: Vincent Ribrag, MD, Gustave Roussy, Cancer Campus, Grand Paris
- Study Director: Becker Hewes, MD, AstraZeneca
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00910728
Other Study ID Numbers:
- D1060C00001
First Posted:
Jun 1, 2009
Last Update Posted:
Apr 24, 2017
Last Verified:
Mar 1, 2017
Keywords provided by AstraZeneca
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Commenced 19MAY2009. All subjects recruited to Part A only (based on emerging data). 65 patients were enrolled of which 35 recieved at least 1 dose of AZD1480. |
|---|---|
| Pre-assignment Detail | Patients ≥25 years of age with primary myelofibrosis (MF) and post-polycythaemia vera/essential thrombocythaemia MF who had relapsed, were intolerant of, or were refractory to MF-directed therapy were enrolled. |
| Arm/Group Title | 2.5 mg QD | 5.0 mg QD | 10 mg QD | 30 mg QD | 50 mg QD | 70 mg QD | 10 mg BID | 15 mg BID | 20 mg QD |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules |
| Period Title: Overall Study | |||||||||
| STARTED | 6 | 3 | 3 | 3 | 6 | 1 | 6 | 4 | 3 |
| COMPLETED | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
| NOT COMPLETED | 6 | 3 | 3 | 3 | 5 | 1 | 6 | 3 | 3 |
Baseline Characteristics
| Arm/Group Title | 2.5 mg QD | 5.0 mg QD | 10 mg QD | 70 mg QD | 15 mg BID | 30 mg QD | 50 mg QD | 10 mg BID | 20 mg QD | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | Total of all reporting groups |
| Overall Participants | 6 | 3 | 3 | 1 | 4 | 3 | 6 | 6 | 3 | 35 |
| Age (years) [Mean (Standard Deviation) ] | ||||||||||
| Mean (Standard Deviation) [years] |
57.5
(7.7)
|
66.3
(9.6)
|
76.7
(10.5)
|
56.0
(0)
|
66.5
(10.3)
|
49.3
(4.2)
|
69.3
(3.8)
|
65.3
(11.3)
|
75.7
(3.8)
|
65.1
(10.6)
|
| Sex: Female, Male (Count of Participants) | ||||||||||
| Female |
1
16.7%
|
1
33.3%
|
1
33.3%
|
1
100%
|
0
0%
|
1
33.3%
|
5
83.3%
|
2
33.3%
|
2
66.7%
|
14
40%
|
| Male |
5
83.3%
|
2
66.7%
|
2
66.7%
|
0
0%
|
4
100%
|
2
66.7%
|
1
16.7%
|
4
66.7%
|
1
33.3%
|
21
60%
|
Outcome Measures
| Title | Pharmacokinetic Parameters Following Single Dosing: AUC0-12 |
|---|---|
| Description | Single dose AUC0-12 (ug*h/L) |
| Time Frame | 0 to 12 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic. Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available). |
| Arm/Group Title | 2.5 mg QD | 5.0 mg QD | 10 mg QD | 30 mg QD | 70 mg QD | 10 mg BID | 15 mg BID | 50 mg QD | 20 mg QD |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules |
| Measure Participants | 6 | 3 | 3 | 3 | 1 | 6 | 4 | 6 | 3 |
| Geometric Mean (Standard Deviation) [ug*h/L] |
69.2
(27.5)
|
295
(68.2)
|
278
(257)
|
1860
(546)
|
5800
(0)
|
425
(190)
|
497
(191)
|
3090
(2060)
|
472
(257)
|
| Title | Pharmacokinetic Parameters Following Single Dosing: AUC0-24 |
|---|---|
| Description | Single dose AUC0-24 (ug*h/L) |
| Time Frame | 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic. Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available). From the BID schedule we can not derive the single dosing AUC0_24 and hence this is not presented/calculated. |
| Arm/Group Title | 2.5 mg QD | 5.0 mg QD | 10 mg QD | 30 mg QD | 70 mg QD | 10 mg BID | 15 mg BID | 50 mg QD | 20 mg QD |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules |
| Measure Participants | 6 | 3 | 3 | 3 | 1 | 0 | 0 | 6 | 3 |
| Geometric Mean (Standard Deviation) [ug*h/L] |
70.2
(28.7)
|
308
(76)
|
285
(252)
|
2000
(624)
|
6260
(0)
|
3540
(2570)
|
508
(280)
|
| Title | Pharmacokinetic Parameters Following Single Dosing:AUC0-inf |
|---|---|
| Description | Single dose AUC(0 to infinity) (ug*h/L) |
| Time Frame | 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic. Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available). From the BID (twice a day dosing schedules) we can not derive the PK parameter AUC0_inf following single dosing. With that these do not contribute. |
| Arm/Group Title | 2.5 mg QD | 5.0 mg QD | 10 mg QD | 30 mg QD | 70 mg QD | 10 mg BID | 15 mg BID | 50 mg QD | 20 mg QD |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules |
| Measure Participants | 6 | 3 | 3 | 3 | 1 | 0 | 0 | 6 | 3 |
| Geometric Mean (Standard Deviation) [ug*h/L] |
83.5
(36.6)
|
312
(79.5)
|
378
(290)
|
2040
(657)
|
6300
(0)
|
3650
(2980)
|
517
(294)
|
| Title | Pharmacokinetic Parameters Following Multiple Dosing: Cmax,ss |
|---|---|
| Description | Multiple dose Cmax,ss (ug/L) |
| Time Frame | On Days 1 and 28 at 0, 0,5, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose, and at 0, 2, 4 hours post dose on Days 4 and 10 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic. Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available). |
| Arm/Group Title | 2.5 mg QD | 5.0 mg QD | 10 mg QD | 30 mg QD | 70 mg QD | 10 mg BID | 15 mg BID | 50 mg QD | 20 mg QD |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules |
| Measure Participants | 5 | 3 | 3 | 3 | 1 | 5 | 4 | 5 | 3 |
| Geometric Mean (Standard Deviation) [ug/L] |
51.3
(18)
|
134
(36.3)
|
176
(179)
|
658
(265)
|
1500
(0)
|
218
(72.3)
|
334
(68.2)
|
924
(461)
|
241
(346)
|
| Title | Pharmacokinetic Parameters Following Multiple Dosing: Cmin,ss |
|---|---|
| Description | Multiple dose Cmin,ss (ug/L) |
| Time Frame | On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose and at 0, 2, 4 hours post-dose on Days 4 and 10. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic. Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available). |
| Arm/Group Title | 2.5 mg QD | 5.0 mg QD | 10 mg QD | 30 mg QD | 70 mg QD | 10 mg BID | 15 mg BID | 50 mg QD | 20 mg QD |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules |
| Measure Participants | 6 | 3 | 3 | 3 | 1 | 6 | 4 | 6 | 3 |
| Geometric Mean (Standard Deviation) [ug/L] |
69.2
(27.5)
|
295
(68.2)
|
278
(257)
|
1860
(546)
|
5800
(0)
|
425
(190)
|
497
(191)
|
3090
(2060)
|
472
(257)
|
| Title | Pharmacokinetic Parameters Following Single Dosing: Cmax |
|---|---|
| Description | Single dose Cmax (ug/L) |
| Time Frame | 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic. Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available). |
| Arm/Group Title | 2.5 mg QD | 5.0 mg QD | 10 mg QD | 30 mg QD | 70 mg QD | 10 mg BID | 15 mg BID | 50 mg QD | 20 mg QD |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules |
| Measure Participants | 6 | 3 | 3 | 3 | 1 | 6 | 4 | 6 | 3 |
| Geometric Mean (Standard Deviation) [ug/L] |
69.9
(32.7)
|
133
(54.7)
|
157
(145)
|
739
(307)
|
2600
(0)
|
273
(62.2)
|
324
(79.5)
|
1320
(379)
|
268
(227)
|
| Title | Pharmacokinetic Parameters Following Single Dosing: Vz/F |
|---|---|
| Description | Single dose Vz/F (L) |
| Time Frame | 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic. Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available). Due to the nature of the dosing schedule this PK parameter was not reported for the BID (twice daily dosing) groups. |
| Arm/Group Title | 2.5 mg QD | 5.0 mg QD | 10 mg QD | 30 mg QD | 70 mg QD | 10 mg BID | 15 mg BID | 50 mg QD | 20 mg QD |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules |
| Measure Participants | 6 | 3 | 3 | 3 | 1 | 0 | 0 | 6 | 3 |
| Geometric Mean (Standard Deviation) [L] |
222
(125)
|
108
(28.1)
|
138
(161)
|
97
(15)
|
57.9
(0)
|
105
(82.2)
|
284
(92.3)
|
| Title | Pharmacokinetic Parameters Following Single Dosing: CL/F |
|---|---|
| Description | Single dose CL/F (L/h) |
| Time Frame | 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic. Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available). |
| Arm/Group Title | 2.5 mg QD | 5.0 mg QD | 10 mg QD | 30 mg QD | 70 mg QD | 10 mg BID | 15 mg BID | 50 mg QD | 20 mg QD |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules |
| Measure Participants | 6 | 3 | 3 | 3 | 1 | 6 | 4 | 6 | 3 |
| Geometric Mean (Standard Deviation) [L/h] |
35.2
(13.9)
|
16
(4.25)
|
34.8
(22.5)
|
14.7
(5.52)
|
11.1
(0)
|
22.6
(9.05)
|
29.7
(13)
|
13.8
(8.5)
|
38.7
(16.7)
|
| Title | Pharmacokinetic Parameters Following Multiple Dosing: CLss/F |
|---|---|
| Description | Multiple dose CLss/F (L/h) |
| Time Frame | On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post dose and at 0, 2, 4 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic. Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available). |
| Arm/Group Title | 2.5 mg QD | 5.0 mg QD | 10 mg QD | 30 mg QD | 70 mg QD | 10 mg BID | 15 mg BID | 50 mg QD | 20 mg QD |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules |
| Measure Participants | 5 | 3 | 3 | 3 | 1 | 5 | 4 | 6 | 3 |
| Geometric Mean (Standard Deviation) [L/h] |
37.8
(6)
|
15.8
(4.4)
|
30.1
(21.7)
|
17
(5.26)
|
9.57
(0)
|
20
(6.91)
|
20.4
(13.8)
|
16
(8.94)
|
20.8
(21)
|
| Title | Pharamcokinetic Parameters Following Single Dosing: Tmax |
|---|---|
| Description | Single dose Tmax (h) |
| Time Frame | 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 2.5 mg QD | 5.0 mg QD | 10 mg QD | 30 mg QD | 70 mg QD | 10 mg BID | 15 mg BID | 50 mg QD | 20 mg QD |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules |
| Measure Participants | 6 | 3 | 3 | 3 | 1 | 6 | 4 | 6 | 3 |
| Median (Full Range) [h] |
0.625
|
0.75
|
0.75
|
1
|
0.75
|
0.625
|
0.875
|
0.89
|
0.75
|
| Title | Pharamcokinetic Parameters Following Multiple Dosing: Tmax,ss |
|---|---|
| Description | Multiple dose Tmax,ss (h) |
| Time Frame | On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose and at 0, 2, 4 hours post-dose on Days 4 and 10 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 2.5 mg QD | 5.0 mg QD | 10 mg QD | 30 mg QD | 70 mg QD | 10 mg BID | 15 mg BID | 50 mg QD | 20 mg QD |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules |
| Measure Participants | 6 | 3 | 3 | 3 | 1 | 6 | 4 | 6 | 3 |
| Median (Full Range) [h] |
0.5
|
0.78
|
0.77
|
0.75
|
1.5
|
1
|
0.875
|
0.78
|
1
|
| Title | Inhibition of PSTAT3 (Count) |
|---|---|
| Description | PSTAT3 inhinition |
| Time Frame | 2hrs and 4 hrs post dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 2.5 mg QD | 5.0 mg QD | 10 mg QD | 30 mg QD | 70 mg QD | 10 mg BID | 15 mg BID | 50 mg QD | 20 mg QD |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules |
| Measure Participants | 6 | 3 | 3 | 3 | 1 | 6 | 4 | 6 | 3 |
| 2 Hours post dose |
0
|
0
|
0
|
1
|
0
|
0
|
0
|
3
|
0
|
| 4 Hours post dose |
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Adverse Events
| Time Frame | Throughout study continuously and 30 days post discontinuation of treatment | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||||
| Arm/Group Title | 2.5 mg QD | 5.0 mg QD | 10 mg QD | 70 mg QD | 15 mg BID | 20 mg QD | 30 mg QD | 50 mg QD | 10 mg BID | |||||||||
| Arm/Group Description | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | AZD1480 may be administered orally in capsules | |||||||||
All Cause Mortality |
||||||||||||||||||
| 2.5 mg QD | 5.0 mg QD | 10 mg QD | 70 mg QD | 15 mg BID | 20 mg QD | 30 mg QD | 50 mg QD | 10 mg BID | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||||
Serious Adverse Events |
||||||||||||||||||
| 2.5 mg QD | 5.0 mg QD | 10 mg QD | 70 mg QD | 15 mg BID | 20 mg QD | 30 mg QD | 50 mg QD | 10 mg BID | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/6 (33.3%) | 2/3 (66.7%) | 0/3 (0%) | 0/1 (0%) | 1/4 (25%) | 3/3 (100%) | 0/3 (0%) | 4/6 (66.7%) | 3/6 (50%) | |||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||
| ANAEMIA | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 |
| NEUTROPENIA | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| SPLENIC INFARCTION | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Cardiac disorders | ||||||||||||||||||
| ATRIAL FLUTTER/FIBRILLATION | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| CARDIAC FAILURE CHRONIC | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| CORONARY ARTERY DISEASE | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| TACHYCARDIA | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| General disorders | ||||||||||||||||||
| PYREXIA | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Infections and infestations | ||||||||||||||||||
| PNEUMONIA | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||||
| CRANIOCEREBRAL INJURY | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| UPPER LIMB FRACTURE | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Investigations | ||||||||||||||||||
| HAEMOGLOBIN DECREASED | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||||||||
| DEHYDRATION | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| GOUT | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||
| BASAL CELL CARCINOMA | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Nervous system disorders | ||||||||||||||||||
| APHASIA | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| AMNESIA | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| ATAXIA | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| DYSARTHRIA | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Psychiatric disorders | ||||||||||||||||||
| CONFUSIONAL STATE | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||||||||
| 2.5 mg QD | 5.0 mg QD | 10 mg QD | 70 mg QD | 15 mg BID | 20 mg QD | 30 mg QD | 50 mg QD | 10 mg BID | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/6 (100%) | 3/3 (100%) | 3/3 (100%) | 1/1 (100%) | 4/4 (100%) | 3/3 (100%) | 3/3 (100%) | 6/6 (100%) | 6/6 (100%) | |||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||
| ANAEMIA | 1/6 (16.7%) | 1 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 4/6 (66.7%) | 4 | 1/6 (16.7%) | 1 |
| NEUTROPENIUA | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| THROMBOCYTOPENIA | 1/6 (16.7%) | 1 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 2/6 (33.3%) | 2 |
| Eye disorders | ||||||||||||||||||
| RETINAL HAEMORRHAGE | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| CATARAC | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 2/6 (33.3%) | 2 |
| CONJUNCTIVAL HAEMORRHAGE | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| DRY EYE | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 3/6 (50%) | 3 | 3/6 (50%) | 3 |
| HAEMORRHAGE | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| KERATITI | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 | 1/6 (16.7%) | 1 |
| Gastrointestinal disorders | ||||||||||||||||||
| DIARRHOEA | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 | 1/6 (16.7%) | 1 |
| VOMITING | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 |
| ASCITES | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| ABDOMINAL DISTENSION | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 |
| ABDOMINAL PAIN | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 2/3 (66.7%) | 2 | 2/6 (33.3%) | 2 | 0/6 (0%) | 0 |
| CONSTIPATION | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 |
| GASTROOESOPHAGEAL REFLUX DISEASE | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| HAEMORRHOIDS | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 | 0/6 (0%) | 0 |
| NAUSEA | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 |
| General disorders | ||||||||||||||||||
| FATIGUE | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| ASTHENIA | 2/6 (33.3%) | 2 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 2/3 (66.7%) | 2 | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 1 | 4/6 (66.7%) | 4 |
| MUCOSAL INFLAMMATION | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 |
| PYREXIA | 2/6 (33.3%) | 2 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| HYPERTHERMIA | 1/6 (16.7%) | 1 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| OEMEMA PERIPHERAL | 1/6 (16.7%) | 1 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/1 (100%) | 1 | 2/4 (50%) | 2 | 2/3 (66.7%) | 2 | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 | 3/6 (50%) | 3 |
| OEDEMA | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/1 (100%) | 1 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Hepatobiliary disorders | ||||||||||||||||||
| HYPERBILIRUBINAEMIA | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Infections and infestations | ||||||||||||||||||
| FOLLICULITIS | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||||
| EXCORIATION | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Investigations | ||||||||||||||||||
| WEIGHT INCREASE | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 |
| CARDIAC MURMUR | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||
| MUSCLE SPASMS | 1/6 (16.7%) | 1 | 1/3 (33.3%) | 1 | 2/3 (66.7%) | 2 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 2/6 (33.3%) | 2 |
| BONE PAIN | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 |
| MUSCULOSKELETAL PAIN | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| MYALGIA AGGRAVATED | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| PAIN | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Nervous system disorders | ||||||||||||||||||
| DIZZINESS | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/1 (100%) | 1 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 2/3 (66.7%) | 2 | 3/6 (50%) | 3 | 1/6 (16.7%) | 1 |
| HEADACHE | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/1 (100%) | 1 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 |
| PARAESTHES | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Psychiatric disorders | ||||||||||||||||||
| CONFUSIONAL STATE | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| INSOMNIA | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Renal and urinary disorders | ||||||||||||||||||
| PROTEINURIA | 3/6 (50%) | 3 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| HAEMATURIA | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||
| DYSPNOEA | 0/6 (0%) | 0 | 1/1 (100%) | 1 | 1/1 (100%) | 1 | 0/0 (NaN) | 0 | 1/1 (100%) | 1 | 1/1 (100%) | 1 | 1/1 (100%) | 1 | 1/1 (100%) | 1 | 2/2 (100%) | 2 |
| EPITAXIS | 1/6 (16.7%) | 1 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||||||
| ECCHYMOSI | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| PETECHIAE | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| PRURITIS | 0/6 (0%) | 0 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/1 (0%) | 0 | 0/4 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| RASH | 0/6 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/1 (0%) | 0 | 1/4 (25%) | 1 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Dr Gregory Curt, MD |
|---|---|
| Organization | AstraZeneca |
| Phone | +1 301 398 0109 |
| Gregory.Curt@astrazeneca.com |
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00910728
Other Study ID Numbers:
- D1060C00001
First Posted:
Jun 1, 2009
Last Update Posted:
Apr 24, 2017
Last Verified:
Mar 1, 2017