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Study to Determine the Safety, Tolerability, and Pharmacokinetic (PK) Profile of EGT0001474 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Theracos
ClinicalTrials.gov Identifier:
NCT00854113
First received: February 27, 2009
Last updated: July 18, 2011
Last verified: July 2011
History of Changes
Results First Received: October 25, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Safety and Tolerability of EGT0001474 in Healthy Volunteers
Interventions: Drug: EGT0001474
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Part 1 - Single Dose EGT0001474 2.5 mg Treatment group - received 2.5 mg single dose of EGT0001474
Part 1 - Single Dose EGT0001474 5 mg Treatment group- received 5 mg single dose of EGT0001474
Part 1 -Single Dose EGT0001474 10 mg Treatment group- received 10 mg single dose of EGT0001474
Part 1 - Single Dose EGT0001474 25 mg Treatment group- received 25 mg single dose of EGT0001474
Part 1 - Single Dose EGT0001474 75 mg Treatment group- received 75 mg single dose of EGT0001474
Part 1 - Single Dose EGT0001474 150mg Treatment group- received 150 mg single dose of EGT0001474
Part 1 - Single Dose Placebo Placebo group- received single dose of placebo capsule
Part 2 - Mutiple Dose EGT0001474 10 mg Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
Part 2 - Multiple Dose EGT0001474 50 mg Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
Part 2 - Multiple Dose EGT0001474 150mg Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
Part 2 - Multiple Dose Placebo Placebo group- received placebo capsules for 14 days

Participant Flow:   Overall Study
    Part 1 - Single Dose EGT0001474 2.5 mg     Part 1 - Single Dose EGT0001474 5 mg     Part 1 -Single Dose EGT0001474 10 mg     Part 1 - Single Dose EGT0001474 25 mg     Part 1 - Single Dose EGT0001474 75 mg     Part 1 - Single Dose EGT0001474 150mg     Part 1 - Single Dose Placebo     Part 2 - Mutiple Dose EGT0001474 10 mg     Part 2 - Multiple Dose EGT0001474 50 mg     Part 2 - Multiple Dose EGT0001474 150mg     Part 2 - Multiple Dose Placebo  
STARTED     6     6     6     6     6     6     12     8     8     8     6  
COMPLETED     6     6     6     6     6     6     12     5     7     8     6  
NOT COMPLETED     0     0     0     0     0     0     0     3     1     0     0  
Adverse Event                 0                 0                 0                 0                 0                 0                 0                 2                 0                 0                 0  
Withdrawal by Subject                 0                 0                 0                 0                 0                 0                 0                 1                 1                 0                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Part 1 - Single Dose EGT0001474 2.5 mg Treatment group - received 2.5 mg single dose of EGT0001474
Part 1 - Single Dose EGT0001474 5 mg Treatment group- received 5 mg single dose of EGT0001474
Part 1 -Single Dose EGT0001474 10 mg Treatment group- received 10 mg single dose of EGT0001474
Part 1 - Single Dose EGT0001474 25 mg Treatment group- received 25 mg single dose of EGT0001474
Part 1 - Single Dose EGT0001474 75 mg Treatment group- received 75 mg single dose of EGT0001474
Part 1 - Single Dose EGT0001474 150mg Treatment group- received 150 mg single dose of EGT0001474
Part 1 - Single Dose Placebo Placebo group- received single dose of placebo capsule
Part 2 - Mutiple Dose EGT0001474 10 mg Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
Part 2 - Multiple Dose EGT0001474 50 mg Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
Part 2 - Multiple Dose EGT0001474 150mg Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
Part 2 - Multiple Dose Placebo Placebo group- received placebo capsules for 14 days
Total Total of all reporting groups

Baseline Measures
    Part 1 - Single Dose EGT0001474 2.5 mg     Part 1 - Single Dose EGT0001474 5 mg     Part 1 -Single Dose EGT0001474 10 mg     Part 1 - Single Dose EGT0001474 25 mg     Part 1 - Single Dose EGT0001474 75 mg     Part 1 - Single Dose EGT0001474 150mg     Part 1 - Single Dose Placebo     Part 2 - Mutiple Dose EGT0001474 10 mg     Part 2 - Multiple Dose EGT0001474 50 mg     Part 2 - Multiple Dose EGT0001474 150mg     Part 2 - Multiple Dose Placebo     Total  
Number of Participants  
[units: participants]
 		  6     6     6     6     6     6     12     8     8     8     6     78  
Age  
[units: years]
Mean ( Full Range ) 		  43  
  ( 29 to 55 )   		  26  
  ( 18 to 31 )   		  25  
  ( 19 to 40 )   		  32  
  ( 18 to 55 )   		  29  
  ( 23 to 35 )   		  35  
  ( 23 to 55 )   		  33  
  ( 19 to 53 )   		  30  
  ( 20 to 44 )   		  35  
  ( 21 to 49 )   		  22  
  ( 18 to 28 )   		  26  
  ( 22 to 32 )   		  32  
  ( 18 to 55 )  
Gender  
[units: participants]
 		                       
Female     1     0     0     1     0     0     0     8     6     8     6     30  
Male     5     6     6     5     6     6     12     0     2     0     0     48  
Ethnicity (NIH/OMB)  
[units: participants]
 		                       
Hispanic or Latino     2     2     1     1     0     0     1     1     3     1     0     12  
Not Hispanic or Latino     4     4     5     5     6     6     11     7     5     7     6     66  
Unknown or Not Reported     0     0     0     0     0     0     0     0     0     0     0     0  
Race/Ethnicity, Customized  
[units: 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     6     5     3     6     4     6     11     7     5     6     5     64  
White     0     1     1     0     2     0     0     1     1     0     1     7  
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  
Others     0     0     2     0     0     0     1     0     2     2     0     7  



  Outcome Measures
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1.  Primary:   Cmax   [ Time Frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days ]
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Measure Type Primary
Measure Title Cmax
Measure Description Pharmacokinetics results. Cmax -Maximum plasma drug concentration
Time Frame Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days  
Safety Issue Yes  

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
Part 1 - Single Dose EGT0001474 2.5 mg Treatment group - received 2.5 mg single dose of EGT0001474
Part 1 - Single Dose EGT0001474 5 mg Treatment group- received 5 mg single dose of EGT0001474
Part 1 -Single Dose EGT0001474 10 mg Treatment group- received 10 mg single dose of EGT0001474
Part 1 - Single Dose EGT0001474 25 mg Treatment group- received 25 mg single dose of EGT0001474
Part 1 - Single Dose EGT0001474 75 mg Treatment group- received 75 mg single dose of EGT0001474
Part 1 - Single Dose EGT0001474 150mg Treatment group- received 150 mg single dose of EGT0001474
Part 1 - Single Dose Placebo Placebo group- received single dose of placebo capsule
Part 2 - Mutiple Dose EGT0001474 10 mg Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
Part 2 - Multiple Dose EGT0001474 50 mg Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
Part 2 - Multiple Dose EGT0001474 150mg Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
Part 2 - Multiple Dose Placebo Placebo group- received placebo capsules for 14 days

Measured Values
    Part 1 - Single Dose EGT0001474 2.5 mg     Part 1 - Single Dose EGT0001474 5 mg     Part 1 -Single Dose EGT0001474 10 mg     Part 1 - Single Dose EGT0001474 25 mg     Part 1 - Single Dose EGT0001474 75 mg     Part 1 - Single Dose EGT0001474 150mg     Part 1 - Single Dose Placebo     Part 2 - Mutiple Dose EGT0001474 10 mg     Part 2 - Multiple Dose EGT0001474 50 mg     Part 2 - Multiple Dose EGT0001474 150mg     Part 2 - Multiple Dose Placebo  
Number of Participants Analyzed  
[units: participants]
 		  6     6     6     6     6     6     12     8     8     8     6  
Cmax  
[units: ng/ml]
Mean ± Standard Deviation 		  12.7  ± 1.08     28  ± 10.2     90.7  ± 31.7     194  ± 53.3     537  ± 198     1183  ± 434     NA  ± NA [1]   85.7  ± 27.9     465  ± 126     1202  ± 345     NA  ± NA [1]
[1] Placebo did not receive EGT001474 drug.

No statistical analysis provided for Cmax



2.  Primary:   Tmax   [ Time Frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days ]
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3.  Primary:   AUC 0-t   [ Time Frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days ]
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4.  Primary:   t1/2   [ Time Frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days ]
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5.  Primary:   AUC 0 -24   [ Time Frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days ]
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6.  Primary:   Terminal Rate Constant.   [ Time Frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days ]
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7.  Primary:   CL/F   [ Time Frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days ]
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8.  Primary:   VZ/F   [ Time Frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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.  


Results Point of Contact:  
Name/Title: Yuan-Di Halvorsen
Organization: Theracos
phone: 617-726-4236
e-mail: yhalvorsen@ccib.mgh.harvard.edu


No publications provided


Responsible Party: Albert Collinson Ph.D, President and CEO, Theracos
ClinicalTrials.gov Identifier: NCT00854113     History of Changes
Other Study ID Numbers: THR-1474-C-328
Study First Received: February 27, 2009
Results First Received: October 25, 2010
Last Updated: July 18, 2011
Health Authority: United States: Food and Drug Administration