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A Dose Ascending, Study To Examine The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of GSK233705B.

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ClinicalTrials.gov Identifier: NCT00453479
Recruitment Status : Completed
First Posted : March 29, 2007
Results First Posted : February 8, 2018
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Primary Purpose: Diagnostic
Condition: Pulmonary Disease, Chronic Obstructive
Intervention: Drug: GSK233705B

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From 29 March 2007 to 11 October 2007, total of 23 participants with chronic obstructive pulmonary disease (COPD) were randomized at four centres in the Netherlands. DISKUS™ is registered product of GlaxoSmithKline.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Participants entered into Cohort I received single inhaled dose of dry powder inhaler (DPI) of matching placebo administered twice daily for 7 days and those in Cohort II received two inhaled dose of DPI matching placebo administered twice daily for 7 days. Matching placebo was administered via the DISKUS inhaler (60 doses) and was formulated with lactose only as a vehicle to make 12.5 milligrams (mg).
GSK233705 50 µg Twice Daily Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 micrograms (µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
GSK233705 100 µg Twice Daily Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.

Participant Flow:   Overall Study
    Placebo   GSK233705 50 µg Twice Daily   GSK233705 100 µg Twice Daily
STARTED   6   9   8 
COMPLETED   6   9   8 
NOT COMPLETED   0   0   0 



  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
Placebo Participants entered into Cohort I received single inhaled dose of DPI of matching placebo administered twice daily for 7 days and those in Cohort II received two inhaled dose of DPI matching placebo administered twice daily for 7 days. Matching placebo was administered via the DISKUS inhaler (60 doses) formulated with lactose only as a vehicle to make 12.5 mg.
GSK233705 50 µg Twice Daily Participants entered into Cohort I received single inhaled dose of DPI of GSK233705 50 µg administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
GSK233705 100 µg Twice Daily Participants entered into Cohort II received two inhaled dose of DPI GSK233705 (50 µg) administered twice daily for 7 days. GSK233705 50 μg blister was administered via the DISKUS inhaler (60 doses) and was formulated with magnesium stearate (0.5%) as a vehicle to make 12.5 mg.
Total Total of all reporting groups

Baseline Measures
   Placebo   GSK233705 50 µg Twice Daily   GSK233705 100 µg Twice Daily   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   9   8   23 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.0  (11.15)   66.4  (6.31)   59.0  (7.27)   62.2  (8.48) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      1  16.7%      0   0.0%      3  37.5%      4  17.4% 
Male      5  83.3%      9 100.0%      5  62.5%      19  82.6% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      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% 
Black or African American      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
White      6 100.0%      9 100.0%      8 100.0%      23 100.0% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)   [ Time Frame: Up to follow-up (approximately 45 days) ]

2.  Primary:   Summary of Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)   [ Time Frame: Up to Day 7 (24 hours post-dose) ]

3.  Primary:   Summary of Mean Heart Rate   [ Time Frame: Up to Day 7 (24 hour post dose) ]

4.  Primary:   Maximum Value of SBP and DBP (0-4 Hour) for the Morning Dose   [ Time Frame: Up to Day 7 (0-4 hour) ]

5.  Primary:   Maximum Value of Heart Rate (0-4 Hour) for the Morning Dose   [ Time Frame: Up to Day 7 (0-4 hour) ]

6.  Primary:   Weighted Mean of SBP and DBP (0-4 Hour) for the Morning Dose   [ Time Frame: Up to Day 7 (0-4 hour) ]

7.  Primary:   Weighted Mean of Heart Rate (0-4 Hour) for the Morning Dose   [ Time Frame: Up to Day 7 (0-4 hour) ]

8.  Primary:   Number of Participants With Abnormal 12-lead ECG Findings   [ Time Frame: Up to Day 7 (24 hour post dose) ]

9.  Primary:   Maximum Value (0–4 Hour) for the Morning Dose of ECG Parameters Corrected According to Fredericia’s Formula (QTcF) and Corrected According to Bazett’s Formula (QTc B)   [ Time Frame: Up to Day 7 (0-4 hour) ]

10.  Primary:   Weighted Mean (0–4 h) for the Morning Dose of ECG Parameters QTcF and QTc B   [ Time Frame: Up to Day 7 (0-4 hour) ]

11.  Primary:   Summary of Mean Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)   [ Time Frame: Up to Day 7 (24-hour post dose) ]

12.  Primary:   Number of Participants Who Used Rescue Medication   [ Time Frame: Up to Day 7 ]

13.  Primary:   Number of Participants With Abnormalities in Chemistry Data of Clinical Concern   [ Time Frame: Up to Day 7 ]

14.  Primary:   Number of Participants With Abnormalities in Hematology Data of Clinical Concern   [ Time Frame: Up to Day 7 ]

15.  Primary:   Summary of Microscopy Data for Participants With Abnormal Urinalysis Dipstick Results   [ Time Frame: Up to Day 7 (pre dose) ]

16.  Primary:   Summary of Mean (0–24 Hour) and Maximum (0–24 Hour) Heart Rate Measured Using 24 Hour Using Holter ECG Data   [ Time Frame: Up to Day 7 ]

17.  Secondary:   Plasma Concentrations of GSK233705   [ Time Frame: Day 1 and 7 morning: pre-dose, 5, 15 minutes, 1, 6 and 12 hours post-dose and Day 1 and 7 evening: pre-dose, 5 and 30 post-dose ]

18.  Secondary:   Urine Concentrations of GSK233705   [ Time Frame: Day 1 and 7 throughout 24 hours ]

19.  Secondary:   Derived Plasma PK Parameters-area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC0-tau)   [ Time Frame: Day 1 and 7 morning: pre-dose, 5, 15 minutes, 1, 6 and 12 hours post-dose and Day 1 and 7 evening: pre-dose, 5 and 30 post-dose ]

20.  Secondary:   Derived Plasma PK Parameters-area Under Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-t)   [ Time Frame: Day 1 and 7 morning: pre-dose, 5, 15 minutes, 1, 6 and 12 hours post-dose and Day 1 and 7 evening: pre-dose, 5 and 30 post-dose ]

21.  Secondary:   Derived PK Plasma Parameters-area Under Concentration-maximum Observed Plasma Concentration (Cmax)   [ Time Frame: Day 1 and 7 morning: pre-dose, 5, 15 minutes, 1, 6 and 12 hours post-dose and Day 1 and 7 evening: pre-dose, 5 and 30 post-dose ]

22.  Secondary:   Derived PK Plasma Parameters-area Under Concentration-time of Maximum Observed Plasma Concentration (T-max), Half-life (T-half) and Last Time Point Where the Concentration is Above the Limit of Quantification (T-last)   [ Time Frame: Day 1 and 7 morning: pre-dose, 5, 15 minutes, 1, 6 and 12 hours post-dose and Day 1 and 7 evening: pre-dose, 5 and 30 post-dose ]

23.  Secondary:   Derived Urine Pharmacokinetic (PK) Parameters-area Under the Plasma Concentration-amount of Drug Excreted Unchanged in Urine (Ae)   [ Time Frame: Day 1 and 7 throughout 24 hours ]

24.  Secondary:   Derived Urine PK Parameters-area Under Concentration-fraction of Dose Excreted Unchanged in Urine (Fe)   [ Time Frame: Day 1 and 7 throughout 24 hours ]

25.  Secondary:   Derived Urine PK Parameters-area Under Concentration-renal Clearance (Clr)   [ Time Frame: Day 1 and 7 throughout 24 hours ]


  Serious Adverse Events


  Other Adverse Events


  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

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:
This study has not been published in the scientific literature.


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00453479     History of Changes
Other Study ID Numbers: AC2108378
First Submitted: March 27, 2007
First Posted: March 29, 2007
Results First Submitted: July 19, 2017
Results First Posted: February 8, 2018
Last Update Posted: March 12, 2018