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Trial record 3 of 4 for:    18308683 [PUBMED-IDS]

Safety, Tolerability and Pharmacokinetics Study of EGT0001474 in Subjects With Type 2 Diabetes

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.
 
ClinicalTrials.gov Identifier: NCT00924053
Recruitment Status : Completed
First Posted : June 18, 2009
Results First Posted : August 17, 2011
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Theracos

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetes Mellitus Type 2
Interventions Drug: EGT0001474
Drug: Placebo
Enrollment 24
Recruitment Details The first subject was enrolled on 12 Jun 2009; the last subject was completed on 28 Jul 2009. Subjects participated at a CRO in San Antonio, TX.
Pre-assignment Details For 3 weeks after enrollment and prior to assignment to treatment and receiving drug, subjects were screened (informed consent, medical history, vital signs, electrocardiogram, laboratory test results, and screening for drugs of abuse and alcohol use) and began a 14 day washout period (counseling, review of medications and adverse events).
Arm/Group Title Placebo EGT0001474 25 mg EGT0001474 75 mg EGT0001474 150mg
Hide Arm/Group Description Received 1, 3, or 6 placebo capsules once daily. Received one 25 mg capsule once daily. Received three 25mg capsules once daily. Received six 25 mg capsules once daily.
Period Title: Overall Study
Started 6 6 6 6
Completed 6 6 6 6
Not Completed 0 0 0 0
Arm/Group Title Placebo EGT0001474 25 mg EGT0001474 75 mg EGT0001474 150mg Total
Hide Arm/Group Description Received 1, 3, or 6 placebo capsules once daily. Received one 25 mg capsule once daily. Received three 25mg capsules once daily. Received six 25 mg capsules once daily. Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 6 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
24
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 24 participants
Female
2
  33.3%
3
  50.0%
4
  66.7%
3
  50.0%
12
  50.0%
Male
4
  66.7%
3
  50.0%
2
  33.3%
3
  50.0%
12
  50.0%
1.Primary Outcome
Title Safety and Tolerability of EGT0001474
Hide Description Safety and tolerability were measured in terms of the number of mild, moderate and severe adverse events experienced by any participants.
Time Frame 25 days
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who took study medication were included in the analysis.
Arm/Group Title Placebo EGT0001474 25 mg EGT0001474 75 mg EGT0001474 150mg
Hide Arm/Group Description:
Received 1, 3, or 6 placebo capsules once daily.
Received one 25 mg capsule once daily.
Received three 25mg capsules once daily.
Received six 25 mg capsules once daily.
Overall Number of Participants Analyzed 6 6 6 6
Measure Type: Number
Unit of Measure: Events
Mild adverse events 5 0 9 3
Moderate adverse events 0 0 0 1
Serious adverse events 0 0 0 0
2.Primary Outcome
Title AUC 0-t
Hide Description Area under the plasma concentration-time curve from time 0 to time t
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EGT0001474 25 mg EGT0001474 75 mg EGT0001474 150mg
Hide Arm/Group Description:
Received 1, 3, or 6 placebo capsules once daily.
Received one 25 mg capsule once daily.
Received three 25mg capsules once daily.
Received six 25 mg capsules once daily.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
NA [1]   (NA) 1103.89  (470.31) 3370.29  (499.36) 6177.8  (1691.04)
[1]
Placebo did not receive EGT0001474 drug
3.Primary Outcome
Title AUC0-24
Hide Description Area under the plasma concentration-time curve from time 0 to hour 24
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EGT0001474 25 mg EGT0001474 75 mg EGT0001474 150mg
Hide Arm/Group Description:
Received 1, 3, or 6 placebo capsules once daily.
Received one 25 mg capsule once daily.
Received three 25mg capsules once daily.
Received six 25 mg capsules once daily.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
NA [1]   (NA) 987.3  (368.21) 2990.63  (461.18) 5584.72  (1516.64)
[1]
Placebo did not receive EGT0001474 drug
4.Primary Outcome
Title AUC Inf
Hide Description Area under the plasma concentration-time curve from time 0 to infinity
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EGT0001474 25 mg EGT0001474 75 mg EGT0001474 150mg
Hide Arm/Group Description:
Received 1, 3, or 6 placebo capsules once daily.
Received one 25 mg capsule once daily.
Received three 25mg capsules once daily.
Received six 25 mg capsules once daily.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
NA [1]   (NA) 1165.59  (479.88) 3532.02  (524.74) 6399.55  (1736.38)
[1]
Placebo did not receive EGT0001474 drug
5.Primary Outcome
Title Cmax
Hide Description Maximum plasma concentration
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EGT0001474 25 mg EGT0001474 75 mg EGT0001474 150mg
Hide Arm/Group Description:
Received 1, 3, or 6 placebo capsules once daily.
Received one 25 mg capsule once daily.
Received three 25mg capsules once daily.
Received six 25 mg capsules once daily.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
NA [1]   (NA) 157.23  (76.25) 518.67  (176.36) 1014  (372.63)
[1]
Placebo did not receive EGT0001474 drug
6.Primary Outcome
Title Tmax
Hide Description Time of maximum plasma concentration
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EGT0001474 25 mg EGT0001474 75 mg EGT0001474 150mg
Hide Arm/Group Description:
Received 1, 3, or 6 placebo capsules once daily.
Received one 25 mg capsule once daily.
Received three 25mg capsules once daily.
Received six 25 mg capsules once daily.
Overall Number of Participants Analyzed 6 6 6 6
Median (Full Range)
Unit of Measure: hour
NA [1] 
(NA to NA)
3
(1 to 8)
2
(1 to 6)
2
(0.5 to 6)
[1]
Placebo did not receive EGT0001474 drug
7.Primary Outcome
Title λz
Hide Description Terminal phase rate constant
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EGT0001474 25 mg EGT0001474 75 mg EGT0001474 150mg
Hide Arm/Group Description:
Received 1, 3, or 6 placebo capsules once daily.
Received one 25 mg capsule once daily.
Received three 25mg capsules once daily.
Received six 25 mg capsules once daily.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: 1/hour
NA [1]   (NA) 0.0741  (0.0215) 0.0613  (0.0168) 0.0622  (0.0195)
[1]
Placebo did not receive EGT0001474 drug
8.Primary Outcome
Title t1/2
Hide Description Apparent terminal half life
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EGT0001474 25 mg EGT0001474 75 mg EGT0001474 150mg
Hide Arm/Group Description:
Received 1, 3, or 6 placebo capsules once daily.
Received one 25 mg capsule once daily.
Received three 25mg capsules once daily.
Received six 25 mg capsules once daily.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: hour
NA [1]   (NA) 10.1  (3.21) 12.18  (3.88) 12.15  (3.94)
[1]
Placebo did not receive EGT0001474 drug
9.Primary Outcome
Title CL/F
Hide Description The apparent rate of oral clearance of EGT0001474.Oral clearance was defined as rate of drug removal from the body after oral administration.
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EGT0001474 25 mg EGT0001474 75 mg EGT0001474 150mg
Hide Arm/Group Description:
Received 1, 3, or 6 placebo capsules once daily.
Received one 25 mg capsule once daily.
Received three 25mg capsules once daily.
Received six 25 mg capsules once daily.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: mL/hr
NA [1]   (NA) 24479.26  (9146.52) 21616.42  (3112.38) 24996.33  (7009.45)
[1]
Placebo did not receive EGT0001474 drug
10.Primary Outcome
Title Vz/F
Hide Description Apparent volume of distribution
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EGT0001474 25 mg EGT0001474 75 mg EGT0001474 150mg
Hide Arm/Group Description:
Received 1, 3, or 6 placebo capsules once daily.
Received one 25 mg capsule once daily.
Received three 25mg capsules once daily.
Received six 25 mg capsules once daily.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: mL
NA [1]   (NA) 348376.12  (15666.55) 382783.75  (138953.19) 435944.78  (179821.44)
[1]
Placebo did not receive EGT0001474 drug
Time Frame 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo EGT0001474 25 mg EGT0001474 75 mg EGT0001474 150mg
Hide Arm/Group Description Received 1, 3, or 6 placebo capsules once daily. Received one 25 mg capsule once daily. Received three 25mg capsules once daily. Received six 25 mg capsules once daily.
All-Cause Mortality
Placebo EGT0001474 25 mg EGT0001474 75 mg EGT0001474 150mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo EGT0001474 25 mg EGT0001474 75 mg EGT0001474 150mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Placebo EGT0001474 25 mg EGT0001474 75 mg EGT0001474 150mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/6 (33.33%)      0/6 (0.00%)      4/6 (66.67%)      2/6 (33.33%)    
Gastrointestinal disorders         
Nausea  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  2 1/6 (16.67%)  1
General disorders         
Malaise  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/0  0
Vessel puncture site reaction * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/0  0 0/6 (0.00%)  0
Investigations         
Blood triglyceride increased  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Vessel puncture site haematoma * 1  1/6 (16.67%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Muscle spasms  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Nervous system disorders         
Dizziness  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Headache  1  0/6 (0.00%)  0 0/6 (0.00%)  0 3/6 (50.00%)  4 2/6 (33.33%)  2
Musculoskeletal stiffness  1  0/0  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Yuan-Di Halvorsen
Organization: Theracos, Inc
Phone: 617 726-4236
EMail: yhalvorsen@ccib.mgh.harvard.edu
Publications:
Layout table for additonal information
Responsible Party: Theracos
ClinicalTrials.gov Identifier: NCT00924053     History of Changes
Other Study ID Numbers: THR-1474-C-396
First Submitted: June 16, 2009
First Posted: June 18, 2009
Results First Submitted: October 25, 2010
Results First Posted: August 17, 2011
Last Update Posted: June 17, 2019