We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

SB-681323 IV for Subjects at Risk of Acute Lung Injury or ARDS

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00996840
First Posted: October 16, 2009
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: August 4, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Lung Injury, Acute
Interventions: Drug: SB-681323 Intravenous 3mg
Drug: SB-681323 Intravenous 7.5 mg
Drug: SB-681323 Intravenous 7.5mg
Drug: SB-681323 Intravenous 10mg
Other: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted across 6 centers in the United States, with 5 centers actually enrolling participants. The first participant was enrolled on 16-October-2009 and the last participant completed the study on 09-February-2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Seventy seven participants were randomized in the study and were included in All subject population.

Reporting Groups
  Description
Combined Placebo Eligible participants received matching placebo intravenous (IV) infusion over 4 hours (h) or 24 h for 3 days
Cohort 1-SB-681323, 3 mg, 4 h Eligible participants received SB-681323, 3 milligrams (mg), IV infusion over 4h for 3 days
Cohort 2-SB-681323, 7.5 mg, 24 h Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
Cohort 3-SB-681323, 7.5 mg, 4 h Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
Cohort 4-SB-681323, 10 mg, 24 h Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days

Participant Flow:   Overall Study
    Combined Placebo   Cohort 1-SB-681323, 3 mg, 4 h   Cohort 2-SB-681323, 7.5 mg, 24 h   Cohort 3-SB-681323, 7.5 mg, 4 h   Cohort 4-SB-681323, 10 mg, 24 h
STARTED   20   9   12   18   18 
COMPLETED   19   7   11   17   16 
NOT COMPLETED   1   2   1   1   2 
Adverse Event                0                1                0                0                0 
Physician Decision                0                0                1                1                2 
Withdrawal by Subject                1                1                0                0                0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Combined Placebo Eligible participants received matching placebo IV infusion over 4 h or 24 h for 3 days
Cohort 1-SB-681323, 3 mg, 4 h Eligible participants received SB-681323, 3 mg, IV infusion over 4h for 3 days
Cohort 2-SB-681323, 7.5 mg, 24 h Eligible participants received SB-681323, 7.5 mg, IV infusion over 24h for 3 days
Cohort 3-SB-681323, 7.5 mg, 4 h Eligible participants received SB-681323, 7.5 mg, IV infusion over 4h for 3 days
Cohort 4-SB-681323, 10 mg, 24 h Eligible participants received SB-681323, 10 mg, IV infusion over 24h for 3 days
Total Total of all reporting groups

Baseline Measures
   Combined Placebo   Cohort 1-SB-681323, 3 mg, 4 h   Cohort 2-SB-681323, 7.5 mg, 24 h   Cohort 3-SB-681323, 7.5 mg, 4 h   Cohort 4-SB-681323, 10 mg, 24 h   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   9   12   18   18   77 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.2  (17.70)   47.4  (19.31)   34.5  (15.61)   44.1  (15.89)   46.1  (21.80)   42.7  (18.24) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      3  15.0%      3  33.3%      1   8.3%      4  22.2%      5  27.8%      16  20.8% 
Male      17  85.0%      6  66.7%      11  91.7%      14  77.8%      13  72.2%      61  79.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
           
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      1   5.6%      0   0.0%      1   1.3% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      8  40.0%      0   0.0%      3  25.0%      3  16.7%      4  22.2%      18  23.4% 
White      11  55.0%      9 100.0%      8  66.7%      12  66.7%      13  72.2%      53  68.8% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   5.0%      0   0.0%      1   8.3%      2  11.1%      1   5.6%      5   6.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count   [ Time Frame: “Day 2, pre-dose", "Day 3, pre-dose", "Day 3, 24 h" and "Follow up (Day 7)" ]

2.  Primary:   Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)   [ Time Frame: “Day 2, pre-dose", "Day 3, pre-dose", "Day 3, 24 h" and "Follow up (Day 7)" ]

3.  Primary:   Mean Hematology Parameters- Mean Corpuscle Hemoglobin   [ Time Frame: “Day 2, pre-dose", "Day 3, pre-dose", "Day 3, 24 h" and "Follow up (Day 7)" ]

4.  Primary:   Hematology Parameters-Mean Corpuscle Volume   [ Time Frame: “Day 2, pre-dose", "Day 3, pre-dose", "Day 3, 24 h" and "Follow up (Day 7)" ]

5.  Primary:   Mean Hematology Parameters-reticulocytes, Red Blood Cell Count   [ Time Frame: “Day 2, pre-dose", "Day 3, pre-dose", "Day 3, 24 h" and "Follow up (Day 7)" ]

6.  Primary:   Mean Clinical Chemistry Parameters- Albumin and Total Protein   [ Time Frame: “Day 2, pre-dose", "Day 3, pre-dose", "Day 3, 24 h" and "Follow up (Day 7)" ]

7.  Primary:   Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase   [ Time Frame: “Day 2, pre-dose", "Day 3, pre-dose", "Day 3, 24 h" and "Follow up (Day 7)" ]

8.  Primary:   Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid   [ Time Frame: “Day 2, pre-dose", "Day 3, pre-dose", "Day 3, 24 h" and "Follow up (Day 7)" ]

9.  Primary:   Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)   [ Time Frame: “Day 2, pre-dose", "Day 3, pre-dose", "Day 3, 24 h" and "Follow up (Day 7)" ]

10.  Primary:   Mean Clinical Chemistry Parameters-estradiol   [ Time Frame: Day 1 (pre-dose) and Day 3 (24 h) ]

11.  Primary:   Mean Clinical Chemistry Parameters-Blood pH at Screening   [ Time Frame: Screening ]

12.  Primary:   Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)   [ Time Frame: For Cohort 1 and 3: “Day 1, 4 h”, “Day 2, pre-dose”, “Day 3, pre-dose and 24 h” and "Follow up (Day 7)"; for Cohort 2 and 4: “Day 2, pre-dose”, “Day 3, pre-dose and 24 h”, and "Follow up (Day 7)" ]

13.  Primary:   Vital Parameter: Mean Heart Rate   [ Time Frame: For Cohort 1 and 3: “Day 1, 4 h”, “Day 2, pre-dose”, “Day 3, pre-dose and 24 h” and "Follow up (Day 7)"; for Cohort 2 and 4: “Day 2, pre-dose”, “Day 3, pre-dose and 24 h”, and "Follow up (Day 7)" ]

14.  Primary:   Vital Sign: Mean Percent Oxygen (O2) in Blood   [ Time Frame: For Cohort 1 and 3: “Day 1, 4 h”, “Day 2, pre-dose”, “Day 3, pre-dose and 24 h” and "Follow up (Day 7)"; for Cohort 2 and 4: “Day 2, pre-dose”, “Day 3, pre-dose and 24 h”, and "Follow up (Day 7)" ]

15.  Primary:   Vital Signs: Mean Oxygen Saturation (SaO2) Via Pulse Oximetry   [ Time Frame: For Cohort 1 and 3: “Day 1, 4 h”, “Day 2, pre-dose”, “Day 3, pre-dose and 24 h”; for Cohort 2 and 4: “Day 2, pre-dose”, and “Day 3, pre-dose and 24 h” ]

16.  Primary:   Vital Signs: Mean Level of Positive End Expiratory Pressure   [ Time Frame: For Cohort 1 and 3: “Day 1, 4 h”, “Day 2, pre-dose”, “Day 3, pre-dose and 24 h”; for Cohort 2 and 4: “Day 2, pre-dose”, and “Day 3, pre-dose and 24 h” ]

17.  Primary:   Vital Signs: Mean Level of Peak and Plateau Ventilator Pressures   [ Time Frame: For Cohort 1 and 3: “Day 1, 4 h”, “Day 2, pre-dose”, “Day 3, pre-dose and 24 h”; for Cohort 2 and 4: “Day 2, pre-dose”, and “Day 3, pre-dose and 24 h” ]

18.  Primary:   Vital Signs: Mean Oxygen Requirement (FiO2) Via Pulse Oximetry   [ Time Frame: For Cohort 1 and 3: “Day 1, 4 h”, “Day 2, pre-dose”, “Day 3, pre-dose and 24 h”; for Cohort 2 and 4: “Day 2, pre-dose”, and “Day 3, pre-dose and 24 h” ]

19.  Primary:   Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals   [ Time Frame: Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow-up (Day 7) ]

20.  Primary:   Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)   [ Time Frame: Up to Follow-up (Day 7) ]

21.  Secondary:   Mean Serum Interleukin-6 Levels   [ Time Frame: 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1 ]

22.  Secondary:   Mean Serum CXCL8 (Interleuin-8) Levels   [ Time Frame: 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1 ]

23.  Secondary:   Mean Serum C-Reactive Protein (CRP) Levels   [ Time Frame: 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1 ]

24.  Secondary:   Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I   [ Time Frame: 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1 ]

25.  Secondary:   Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels   [ Time Frame: 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1 ]

26.  Secondary:   Mean Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours (AUC0-24)   [ Time Frame: For cohort 1 and 3: Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h). For cohort 2 and 4: Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose) ]

27.  Secondary:   Mean Average Concentration (Cavg) of SB-681323   [ Time Frame: For cohort 1 and 3: Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h). For cohort 2 and 4: Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h 10minutes [min], 24h 45min, 27, 34, 40, 80 h since doing on Day 3) ]

28.  Secondary:   Maximum Observed Concentration (Cmax) of SB-681323   [ Time Frame: For cohort 1 and 3: Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h). For cohort 2 and 4: Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h 10 min, 24h 45min, 27, 34, 40, 80 h since doing on Day 3) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00996840     History of Changes
Other Study ID Numbers: 111592
First Submitted: October 15, 2009
First Posted: October 16, 2009
Results First Submitted: August 4, 2017
Results First Posted: October 18, 2017
Last Update Posted: October 18, 2017