Trial Outcomes & Findings for Study to Determine the Safety, Tolerability, and Pharmacokinetic (PK) Profile of EGT0001474 in Healthy Volunteers (NCT NCT00854113)
NCT ID: NCT00854113
Last Updated: 2019-06-06
Results Overview
Pharmacokinetics results. Cmax -Maximum plasma drug concentration
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
78 participants
Primary outcome timeframe
Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
Results posted on
2019-06-06
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
12
|
8
|
8
|
8
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
6
|
12
|
5
|
7
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Study to Determine the Safety, Tolerability, and Pharmacokinetic (PK) Profile of EGT0001474 in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Part 1 - Single Dose EGT0001474 2.5 mg
n=6 Participants
Treatment group - received 2.5 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 5 mg
n=6 Participants
Treatment group- received 5 mg single dose of EGT0001474
|
Part 1 -Single Dose EGT0001474 10 mg
n=6 Participants
Treatment group- received 10 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 25 mg
n=6 Participants
Treatment group- received 25 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 75 mg
n=6 Participants
Treatment group- received 75 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 150mg
n=6 Participants
Treatment group- received 150 mg single dose of EGT0001474
|
Part 1 - Single Dose Placebo
n=12 Participants
Placebo group- received single dose of placebo capsule
|
Part 2 - Mutiple Dose EGT0001474 10 mg
n=8 Participants
Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
|
Part 2 - Multiple Dose EGT0001474 50 mg
n=8 Participants
Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
|
Part 2 - Multiple Dose EGT0001474 150mg
n=8 Participants
Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
|
Part 2 - Multiple Dose Placebo
n=6 Participants
Placebo group- received placebo capsules for 14 days
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
43 years
n=5 Participants
|
26 years
n=7 Participants
|
25 years
n=5 Participants
|
32 years
n=4 Participants
|
29 years
n=21 Participants
|
35 years
n=8 Participants
|
33 years
n=8 Participants
|
30 years
n=24 Participants
|
35 years
n=42 Participants
|
22 years
n=42 Participants
|
26 years
n=42 Participants
|
32 years
n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
30 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
48 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
66 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
64 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Others
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 daysPharmacokinetics results. Cmax -Maximum plasma drug concentration
Outcome measures
| Measure |
Part 1 - Single Dose EGT0001474 2.5 mg
n=6 Participants
Treatment group - received 2.5 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 5 mg
n=6 Participants
Treatment group- received 5 mg single dose of EGT0001474
|
Part 1 -Single Dose EGT0001474 10 mg
n=6 Participants
Treatment group- received 10 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 25 mg
n=6 Participants
Treatment group- received 25 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 75 mg
n=6 Participants
Treatment group- received 75 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 150mg
n=6 Participants
Treatment group- received 150 mg single dose of EGT0001474
|
Part 1 - Single Dose Placebo
n=12 Participants
Placebo group- received single dose of placebo capsule
|
Part 2 - Mutiple Dose EGT0001474 10 mg
n=8 Participants
Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
|
Part 2 - Multiple Dose EGT0001474 50 mg
n=8 Participants
Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
|
Part 2 - Multiple Dose EGT0001474 150mg
n=8 Participants
Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
|
Part 2 - Multiple Dose Placebo
n=6 Participants
Placebo group- received placebo capsules for 14 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax
|
12.7 ng/ml
Standard Deviation 1.08
|
28 ng/ml
Standard Deviation 10.2
|
90.7 ng/ml
Standard Deviation 31.7
|
194 ng/ml
Standard Deviation 53.3
|
537 ng/ml
Standard Deviation 198
|
1183 ng/ml
Standard Deviation 434
|
NA ng/ml
Standard Deviation NA
Placebo did not receive EGT001474 drug.
|
85.7 ng/ml
Standard Deviation 27.9
|
465 ng/ml
Standard Deviation 126
|
1202 ng/ml
Standard Deviation 345
|
NA ng/ml
Standard Deviation NA
Placebo did not receive EGT001474 drug.
|
PRIMARY outcome
Timeframe: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 daysPharmacokinetics results. Time to maximum plasma drug concentration (Tmax) was calculated for each groups
Outcome measures
| Measure |
Part 1 - Single Dose EGT0001474 2.5 mg
n=6 Participants
Treatment group - received 2.5 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 5 mg
n=6 Participants
Treatment group- received 5 mg single dose of EGT0001474
|
Part 1 -Single Dose EGT0001474 10 mg
n=6 Participants
Treatment group- received 10 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 25 mg
n=6 Participants
Treatment group- received 25 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 75 mg
n=6 Participants
Treatment group- received 75 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 150mg
n=6 Participants
Treatment group- received 150 mg single dose of EGT0001474
|
Part 1 - Single Dose Placebo
n=12 Participants
Placebo group- received single dose of placebo capsule
|
Part 2 - Mutiple Dose EGT0001474 10 mg
n=8 Participants
Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
|
Part 2 - Multiple Dose EGT0001474 50 mg
n=8 Participants
Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
|
Part 2 - Multiple Dose EGT0001474 150mg
n=8 Participants
Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
|
Part 2 - Multiple Dose Placebo
n=6 Participants
Placebo group- received placebo capsules for 14 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax
|
4 hour
Interval 4.0 to 6.0
|
2.01 hour
Interval 1.0 to 4.0
|
2 hour
Interval 1.0 to 4.0
|
1.51 hour
Interval 1.0 to 6.0
|
1.5 hour
Interval 1.0 to 3.0
|
1.5 hour
Interval 1.0 to 4.0
|
NA hour
Placebo did not receive EGT001474 drug
|
2.01 hour
Interval 1.0 to 6.0
|
1 hour
Interval 1.0 to 6.05
|
1 hour
Interval 1.0 to 1.0
|
NA hour
Placebo did not receive EGT001474 drug
|
PRIMARY outcome
Timeframe: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 daysPharmacokinetics results. AUC 0-t - Are under plasma concentration-time curve from time 0 time t.
Outcome measures
| Measure |
Part 1 - Single Dose EGT0001474 2.5 mg
n=6 Participants
Treatment group - received 2.5 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 5 mg
n=6 Participants
Treatment group- received 5 mg single dose of EGT0001474
|
Part 1 -Single Dose EGT0001474 10 mg
n=6 Participants
Treatment group- received 10 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 25 mg
n=6 Participants
Treatment group- received 25 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 75 mg
n=6 Participants
Treatment group- received 75 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 150mg
n=6 Participants
Treatment group- received 150 mg single dose of EGT0001474
|
Part 1 - Single Dose Placebo
n=12 Participants
Placebo group- received single dose of placebo capsule
|
Part 2 - Mutiple Dose EGT0001474 10 mg
n=8 Participants
Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
|
Part 2 - Multiple Dose EGT0001474 50 mg
n=8 Participants
Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
|
Part 2 - Multiple Dose EGT0001474 150mg
n=8 Participants
Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
|
Part 2 - Multiple Dose Placebo
n=6 Participants
Placebo group- received placebo capsules for 14 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC 0-t
|
67.4 ng*hr/ml
Standard Deviation 13.9
|
126 ng*hr/ml
Standard Deviation 33.8
|
388 ng*hr/ml
Standard Deviation 108
|
1200 ng*hr/ml
Standard Deviation 320
|
2564 ng*hr/ml
Standard Deviation 607
|
6412 ng*hr/ml
Standard Deviation 1179
|
NA ng*hr/ml
Standard Deviation NA
Placebo did not receive EGT001474 drug.
|
432 ng*hr/ml
Standard Deviation 89.5
|
2146 ng*hr/ml
Standard Deviation 539
|
7733 ng*hr/ml
Standard Deviation 1957
|
NA ng*hr/ml
Standard Deviation NA
Placebo did not receive EGT001474 drug.
|
PRIMARY outcome
Timeframe: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 daysPharmacokinetics results.t 1/2 - apparent terminal half life
Outcome measures
| Measure |
Part 1 - Single Dose EGT0001474 2.5 mg
n=6 Participants
Treatment group - received 2.5 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 5 mg
n=6 Participants
Treatment group- received 5 mg single dose of EGT0001474
|
Part 1 -Single Dose EGT0001474 10 mg
n=6 Participants
Treatment group- received 10 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 25 mg
n=6 Participants
Treatment group- received 25 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 75 mg
n=6 Participants
Treatment group- received 75 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 150mg
n=6 Participants
Treatment group- received 150 mg single dose of EGT0001474
|
Part 1 - Single Dose Placebo
n=12 Participants
Placebo group- received single dose of placebo capsule
|
Part 2 - Mutiple Dose EGT0001474 10 mg
n=8 Participants
Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
|
Part 2 - Multiple Dose EGT0001474 50 mg
n=8 Participants
Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
|
Part 2 - Multiple Dose EGT0001474 150mg
n=8 Participants
Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
|
Part 2 - Multiple Dose Placebo
n=6 Participants
Placebo group- received placebo capsules for 14 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
t1/2
|
3.66 hour
Standard Deviation 0.559
|
4.19 hour
Standard Deviation 1.3
|
5.81 hour
Standard Deviation 1.38
|
9.71 hour
Standard Deviation 3.28
|
9.27 hour
Standard Deviation 1.60
|
11.4 hour
Standard Deviation 2.49
|
NA hour
Standard Deviation NA
Placebo did not receive EGT001474 drug.
|
9.03 hour
Standard Deviation 1.44
|
9.02 hour
Standard Deviation 2.38
|
10.3 hour
Standard Deviation 1.98
|
NA hour
Standard Deviation NA
Placebo did not receive EGT001474 drug.
|
PRIMARY outcome
Timeframe: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 daysPharmacokinetics results. Area under the plasma concentration-time curve from time 0 to 24 hours post-dose.
Outcome measures
| Measure |
Part 1 - Single Dose EGT0001474 2.5 mg
n=6 Participants
Treatment group - received 2.5 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 5 mg
n=6 Participants
Treatment group- received 5 mg single dose of EGT0001474
|
Part 1 -Single Dose EGT0001474 10 mg
n=6 Participants
Treatment group- received 10 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 25 mg
n=6 Participants
Treatment group- received 25 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 75 mg
n=6 Participants
Treatment group- received 75 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 150mg
n=6 Participants
Treatment group- received 150 mg single dose of EGT0001474
|
Part 1 - Single Dose Placebo
n=12 Participants
Placebo group- received single dose of placebo capsule
|
Part 2 - Mutiple Dose EGT0001474 10 mg
n=8 Participants
Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
|
Part 2 - Multiple Dose EGT0001474 50 mg
n=8 Participants
Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
|
Part 2 - Multiple Dose EGT0001474 150mg
n=8 Participants
Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
|
Part 2 - Multiple Dose Placebo
n=6 Participants
Placebo group- received placebo capsules for 14 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC 0 -24
|
85.6 ng*hr/ml
Standard Deviation 9.67
|
145 ng*hr/ml
Standard Deviation 34.4
|
392 ng*hr/ml
Standard Deviation 99.8
|
1121 ng*hr/ml
Standard Deviation 264
|
2383 ng*hr/ml
Standard Deviation 527
|
5828 ng*hr/ml
Standard Deviation 1080
|
NA ng*hr/ml
Standard Deviation NA
Placebo did not receive EGT001474 drug.
|
412 ng*hr/ml
Standard Deviation 73.8
|
1983 ng*hr/ml
Standard Deviation 443
|
6939 ng*hr/ml
Standard Deviation 1675
|
NA ng*hr/ml
Standard Deviation NA
Placebo did not receive EGT001474 drug.
|
PRIMARY outcome
Timeframe: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 daysPharmacokinetics results. Terminal rate constant was estimated by linear regression of logarithmic transformed concentration versus time data
Outcome measures
| Measure |
Part 1 - Single Dose EGT0001474 2.5 mg
n=6 Participants
Treatment group - received 2.5 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 5 mg
n=6 Participants
Treatment group- received 5 mg single dose of EGT0001474
|
Part 1 -Single Dose EGT0001474 10 mg
n=6 Participants
Treatment group- received 10 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 25 mg
n=6 Participants
Treatment group- received 25 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 75 mg
n=6 Participants
Treatment group- received 75 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 150mg
n=6 Participants
Treatment group- received 150 mg single dose of EGT0001474
|
Part 1 - Single Dose Placebo
n=12 Participants
Placebo group- received single dose of placebo capsule
|
Part 2 - Mutiple Dose EGT0001474 10 mg
n=8 Participants
Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
|
Part 2 - Multiple Dose EGT0001474 50 mg
n=8 Participants
Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
|
Part 2 - Multiple Dose EGT0001474 150mg
n=8 Participants
Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
|
Part 2 - Multiple Dose Placebo
n=6 Participants
Placebo group- received placebo capsules for 14 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Rate Constant.
|
0.193 L/hr
Standard Deviation 0.0314
|
0.177 L/hr
Standard Deviation 0.0456
|
0.126 L/hr
Standard Deviation 0.0373
|
0.0799 L/hr
Standard Deviation 0.0308
|
0.0765 L/hr
Standard Deviation 0.0117
|
0.0637 L/hr
Standard Deviation 0.0158
|
NA L/hr
Standard Deviation NA
Placebo did not receive EGT001474 drug.
|
0.0783 L/hr
Standard Deviation 0.0117
|
0.0818 L/hr
Standard Deviation 0.023
|
0.0697 L/hr
Standard Deviation 0.0143
|
NA L/hr
Standard Deviation NA
Placebo did not receive EGT001474 drug.
|
PRIMARY outcome
Timeframe: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 daysPharmacokinetics results. Apparent oral clearance
Outcome measures
| Measure |
Part 1 - Single Dose EGT0001474 2.5 mg
n=6 Participants
Treatment group - received 2.5 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 5 mg
n=6 Participants
Treatment group- received 5 mg single dose of EGT0001474
|
Part 1 -Single Dose EGT0001474 10 mg
n=6 Participants
Treatment group- received 10 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 25 mg
n=6 Participants
Treatment group- received 25 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 75 mg
n=6 Participants
Treatment group- received 75 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 150mg
n=6 Participants
Treatment group- received 150 mg single dose of EGT0001474
|
Part 1 - Single Dose Placebo
n=12 Participants
Placebo group- received single dose of placebo capsule
|
Part 2 - Mutiple Dose EGT0001474 10 mg
n=8 Participants
Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
|
Part 2 - Multiple Dose EGT0001474 50 mg
n=8 Participants
Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
|
Part 2 - Multiple Dose EGT0001474 150mg
n=8 Participants
Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
|
Part 2 - Multiple Dose Placebo
n=6 Participants
Placebo group- received placebo capsules for 14 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
CL/F
|
28.9 L/hr
Standard Deviation 2.89
|
35.3 L/hr
Standard Deviation 8.24
|
25.9 L/hr
Standard Deviation 7.59
|
21.2 L/hr
Standard Deviation 5.18
|
30.1 L/hr
Standard Deviation 8.51
|
23.1 L/hr
Standard Deviation 3.67
|
NA L/hr
Standard Deviation NA
Placebo did not receive EGT001474 drug.
|
24.9 L/hr
Standard Deviation 4.45
|
26.4 L/hr
Standard Deviation 6.49
|
22.6 L/hr
Standard Deviation 4.67
|
NA L/hr
Standard Deviation NA
Placebo did not receive EGT001474 drug.
|
PRIMARY outcome
Timeframe: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 daysPharmacokinetic results. Apparent volume of distribution
Outcome measures
| Measure |
Part 1 - Single Dose EGT0001474 2.5 mg
n=6 Participants
Treatment group - received 2.5 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 5 mg
n=6 Participants
Treatment group- received 5 mg single dose of EGT0001474
|
Part 1 -Single Dose EGT0001474 10 mg
n=6 Participants
Treatment group- received 10 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 25 mg
n=6 Participants
Treatment group- received 25 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 75 mg
n=6 Participants
Treatment group- received 75 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 150mg
n=6 Participants
Treatment group- received 150 mg single dose of EGT0001474
|
Part 1 - Single Dose Placebo
n=12 Participants
Placebo group- received single dose of placebo capsule
|
Part 2 - Mutiple Dose EGT0001474 10 mg
n=8 Participants
Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
|
Part 2 - Multiple Dose EGT0001474 50 mg
n=8 Participants
Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
|
Part 2 - Multiple Dose EGT0001474 150mg
n=8 Participants
Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
|
Part 2 - Multiple Dose Placebo
n=6 Participants
Placebo group- received placebo capsules for 14 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
VZ/F
|
154 Liters
Standard Deviation 37.1
|
222 Liters
Standard Deviation 121
|
208 Liters
Standard Deviation 49.5
|
287 Liters
Standard Deviation 105
|
398 Liters
Standard Deviation 109
|
385 Liters
Standard Deviation 121
|
NA Liters
Standard Deviation NA
Placebo did not receive EGT001474 drug.
|
319 Liters
Standard Deviation 39.3
|
327 Liters
Standard Deviation 54.2
|
333 Liters
Standard Deviation 84.2
|
NA Liters
Standard Deviation NA
Placebo did not receive EGT001474 drug.
|
Adverse Events
Part 1 - Single Dose EGT0001474 2.5 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 - Single Dose EGT0001474 5 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 -Single Dose EGT0001474 10 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 - Single Dose EGT0001474 25 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 - Single Dose EGT0001474 75 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 - Single Dose EGT0001474 150mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 - Single Dose Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2 - Mutiple Dose EGT0001474 10 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2 - Multiple Dose EGT0001474 50 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 2 - Multiple Dose EGT0001474 150mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 2 - Multiple Dose Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1 - Single Dose EGT0001474 2.5 mg
n=6 participants at risk
Treatment group - received 2.5 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 5 mg
n=6 participants at risk
Treatment group- received 5 mg single dose of EGT0001474
|
Part 1 -Single Dose EGT0001474 10 mg
n=6 participants at risk
Treatment group- received 10 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 25 mg
n=6 participants at risk
Treatment group- received 25 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 75 mg
n=6 participants at risk
Treatment group- received 75 mg single dose of EGT0001474
|
Part 1 - Single Dose EGT0001474 150mg
n=6 participants at risk
Treatment group- received 150 mg single dose of EGT0001474
|
Part 1 - Single Dose Placebo
n=12 participants at risk
Placebo group- received single dose of placebo capsule
|
Part 2 - Mutiple Dose EGT0001474 10 mg
n=8 participants at risk
Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
|
Part 2 - Multiple Dose EGT0001474 50 mg
n=8 participants at risk
Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
|
Part 2 - Multiple Dose EGT0001474 150mg
n=8 participants at risk；n=6 participants at risk
Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
|
Part 2 - Multiple Dose Placebo
n=6 participants at risk
Placebo group- received placebo capsules for 14 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Application Site Erythema
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
0.00%
0/12
|
25.0%
2/8 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
50.0%
4/8 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Application Site Irritation
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
General disorders
Asthenia
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
General disorders
Fatigue
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
General disorders
Oedema Peripheral
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
General disorders
Vessel puncture site haematoma
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Nervous system disorders
Headache
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
37.5%
3/8 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Head Discomfort
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Muscle Tightness
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Tongue Ulceration
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/12
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Oropharangeal Pain
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/8
|
0.00%
0/8
|
25.0%
2/8 • Number of events 2
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/6
|
|
Investigations
Cardiac murmur
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/12
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place