Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics Study of EGT0001474 in Subjects With Type 2 Diabetes (NCT NCT00924053)
NCT ID: NCT00924053
Last Updated: 2019-06-17
Results Overview
Safety and tolerability were measured in terms of the number of mild, moderate and severe adverse events experienced by any participants.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
25 days
Results posted on
2019-06-17
Participant Flow
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.
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).
Participant milestones
| Measure |
Placebo
Received 1, 3, or 6 placebo capsules once daily.
|
EGT0001474 25 mg
Received one 25 mg capsule once daily.
|
EGT0001474 75 mg
Received three 25mg capsules once daily.
|
EGT0001474 150mg
Received six 25 mg capsules once daily.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability and Pharmacokinetics Study of EGT0001474 in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Placebo
n=6 Participants
Received 1, 3, or 6 placebo capsules once daily.
|
EGT0001474 25 mg
n=6 Participants
Received one 25 mg capsule once daily.
|
EGT0001474 75 mg
n=6 Participants
Received three 25mg capsules once daily.
|
EGT0001474 150mg
n=6 Participants
Received six 25 mg capsules once daily.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
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
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 25 daysPopulation: All patients who took study medication were included in the analysis.
Safety and tolerability were measured in terms of the number of mild, moderate and severe adverse events experienced by any participants.
Outcome measures
| Measure |
Placebo
n=6 Participants
Received 1, 3, or 6 placebo capsules once daily.
|
EGT0001474 25 mg
n=6 Participants
Received one 25 mg capsule once daily.
|
EGT0001474 75 mg
n=6 Participants
Received three 25mg capsules once daily.
|
EGT0001474 150mg
n=6 Participants
Received six 25 mg capsules once daily.
|
|---|---|---|---|---|
|
Safety and Tolerability of EGT0001474
Mild adverse events
|
5 Events
|
0 Events
|
9 Events
|
3 Events
|
|
Safety and Tolerability of EGT0001474
Moderate adverse events
|
0 Events
|
0 Events
|
0 Events
|
1 Events
|
|
Safety and Tolerability of EGT0001474
Serious adverse events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
PRIMARY outcome
Timeframe: 3 daysArea under the plasma concentration-time curve from time 0 to time t
Outcome measures
| Measure |
Placebo
n=6 Participants
Received 1, 3, or 6 placebo capsules once daily.
|
EGT0001474 25 mg
n=6 Participants
Received one 25 mg capsule once daily.
|
EGT0001474 75 mg
n=6 Participants
Received three 25mg capsules once daily.
|
EGT0001474 150mg
n=6 Participants
Received six 25 mg capsules once daily.
|
|---|---|---|---|---|
|
AUC 0-t
|
NA ng*hr/mL
Standard Deviation NA
Placebo did not receive EGT0001474 drug
|
1103.89 ng*hr/mL
Standard Deviation 470.31
|
3370.29 ng*hr/mL
Standard Deviation 499.36
|
6177.8 ng*hr/mL
Standard Deviation 1691.04
|
PRIMARY outcome
Timeframe: 3 daysArea under the plasma concentration-time curve from time 0 to hour 24
Outcome measures
| Measure |
Placebo
n=6 Participants
Received 1, 3, or 6 placebo capsules once daily.
|
EGT0001474 25 mg
n=6 Participants
Received one 25 mg capsule once daily.
|
EGT0001474 75 mg
n=6 Participants
Received three 25mg capsules once daily.
|
EGT0001474 150mg
n=6 Participants
Received six 25 mg capsules once daily.
|
|---|---|---|---|---|
|
AUC0-24
|
NA ng*hr/mL
Standard Deviation NA
Placebo did not receive EGT0001474 drug
|
987.3 ng*hr/mL
Standard Deviation 368.21
|
2990.63 ng*hr/mL
Standard Deviation 461.18
|
5584.72 ng*hr/mL
Standard Deviation 1516.64
|
PRIMARY outcome
Timeframe: 3 daysArea under the plasma concentration-time curve from time 0 to infinity
Outcome measures
| Measure |
Placebo
n=6 Participants
Received 1, 3, or 6 placebo capsules once daily.
|
EGT0001474 25 mg
n=6 Participants
Received one 25 mg capsule once daily.
|
EGT0001474 75 mg
n=6 Participants
Received three 25mg capsules once daily.
|
EGT0001474 150mg
n=6 Participants
Received six 25 mg capsules once daily.
|
|---|---|---|---|---|
|
AUC Inf
|
NA ng*hr/mL
Standard Deviation NA
Placebo did not receive EGT0001474 drug
|
1165.59 ng*hr/mL
Standard Deviation 479.88
|
3532.02 ng*hr/mL
Standard Deviation 524.74
|
6399.55 ng*hr/mL
Standard Deviation 1736.38
|
PRIMARY outcome
Timeframe: 3 daysMaximum plasma concentration
Outcome measures
| Measure |
Placebo
n=6 Participants
Received 1, 3, or 6 placebo capsules once daily.
|
EGT0001474 25 mg
n=6 Participants
Received one 25 mg capsule once daily.
|
EGT0001474 75 mg
n=6 Participants
Received three 25mg capsules once daily.
|
EGT0001474 150mg
n=6 Participants
Received six 25 mg capsules once daily.
|
|---|---|---|---|---|
|
Cmax
|
NA ng/mL
Standard Deviation NA
Placebo did not receive EGT0001474 drug
|
157.23 ng/mL
Standard Deviation 76.25
|
518.67 ng/mL
Standard Deviation 176.36
|
1014 ng/mL
Standard Deviation 372.63
|
PRIMARY outcome
Timeframe: 3 daysTime of maximum plasma concentration
Outcome measures
| Measure |
Placebo
n=6 Participants
Received 1, 3, or 6 placebo capsules once daily.
|
EGT0001474 25 mg
n=6 Participants
Received one 25 mg capsule once daily.
|
EGT0001474 75 mg
n=6 Participants
Received three 25mg capsules once daily.
|
EGT0001474 150mg
n=6 Participants
Received six 25 mg capsules once daily.
|
|---|---|---|---|---|
|
Tmax
|
NA hour
Placebo did not receive EGT0001474 drug
|
3 hour
Interval 1.0 to 8.0
|
2 hour
Interval 1.0 to 6.0
|
2 hour
Interval 0.5 to 6.0
|
PRIMARY outcome
Timeframe: 3 daysTerminal phase rate constant
Outcome measures
| Measure |
Placebo
n=6 Participants
Received 1, 3, or 6 placebo capsules once daily.
|
EGT0001474 25 mg
n=6 Participants
Received one 25 mg capsule once daily.
|
EGT0001474 75 mg
n=6 Participants
Received three 25mg capsules once daily.
|
EGT0001474 150mg
n=6 Participants
Received six 25 mg capsules once daily.
|
|---|---|---|---|---|
|
λz
|
NA 1/hour
Standard Deviation NA
Placebo did not receive EGT0001474 drug
|
0.0741 1/hour
Standard Deviation 0.0215
|
0.0613 1/hour
Standard Deviation 0.0168
|
0.0622 1/hour
Standard Deviation 0.0195
|
PRIMARY outcome
Timeframe: 3 daysApparent terminal half life
Outcome measures
| Measure |
Placebo
n=6 Participants
Received 1, 3, or 6 placebo capsules once daily.
|
EGT0001474 25 mg
n=6 Participants
Received one 25 mg capsule once daily.
|
EGT0001474 75 mg
n=6 Participants
Received three 25mg capsules once daily.
|
EGT0001474 150mg
n=6 Participants
Received six 25 mg capsules once daily.
|
|---|---|---|---|---|
|
t1/2
|
NA hour
Standard Deviation NA
Placebo did not receive EGT0001474 drug
|
10.1 hour
Standard Deviation 3.21
|
12.18 hour
Standard Deviation 3.88
|
12.15 hour
Standard Deviation 3.94
|
PRIMARY outcome
Timeframe: 3 daysThe apparent rate of oral clearance of EGT0001474.Oral clearance was defined as rate of drug removal from the body after oral administration.
Outcome measures
| Measure |
Placebo
n=6 Participants
Received 1, 3, or 6 placebo capsules once daily.
|
EGT0001474 25 mg
n=6 Participants
Received one 25 mg capsule once daily.
|
EGT0001474 75 mg
n=6 Participants
Received three 25mg capsules once daily.
|
EGT0001474 150mg
n=6 Participants
Received six 25 mg capsules once daily.
|
|---|---|---|---|---|
|
CL/F
|
NA mL/hr
Standard Deviation NA
Placebo did not receive EGT0001474 drug
|
24479.26 mL/hr
Standard Deviation 9146.52
|
21616.42 mL/hr
Standard Deviation 3112.38
|
24996.33 mL/hr
Standard Deviation 7009.45
|
PRIMARY outcome
Timeframe: 3 daysApparent volume of distribution
Outcome measures
| Measure |
Placebo
n=6 Participants
Received 1, 3, or 6 placebo capsules once daily.
|
EGT0001474 25 mg
n=6 Participants
Received one 25 mg capsule once daily.
|
EGT0001474 75 mg
n=6 Participants
Received three 25mg capsules once daily.
|
EGT0001474 150mg
n=6 Participants
Received six 25 mg capsules once daily.
|
|---|---|---|---|---|
|
Vz/F
|
NA mL
Standard Deviation NA
Placebo did not receive EGT0001474 drug
|
348376.12 mL
Standard Deviation 15666.55
|
382783.75 mL
Standard Deviation 138953.19
|
435944.78 mL
Standard Deviation 179821.44
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
EGT0001474 25 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
EGT0001474 75 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
EGT0001474 150mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=6 participants at risk
Received 1, 3, or 6 placebo capsules once daily.
|
EGT0001474 25 mg
n=6 participants at risk
Received one 25 mg capsule once daily.
|
EGT0001474 75 mg
n=6 participants at risk
Received three 25mg capsules once daily.
|
EGT0001474 150mg
n=6 participants at risk
Received six 25 mg capsules once daily.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 1 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
0.00%
0/6 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
0.00%
0/6 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
0.00%
0/6 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
|
Investigations
Blood triglyceride increased
|
0.00%
0/6 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
0.00%
0/6 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
0.00%
0/6 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
16.7%
1/6 • Number of events 1 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
0.00%
0/6 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
16.7%
1/6 • Number of events 1 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
0.00%
0/6 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
0.00%
0/6 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
50.0%
3/6 • Number of events 4 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
33.3%
2/6 • Number of events 2 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
|
General disorders
Malaise
|
0.00%
0/6 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
0.00%
0/6 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
16.7%
1/6 • Number of events 1 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
—
0/0 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.7%
1/6 • Number of events 1 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
0.00%
0/6 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
0.00%
0/6 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
0.00%
0/6 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
|
Nervous system disorders
Musculoskeletal stiffness
|
—
0/0 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
0.00%
0/6 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
16.7%
1/6 • Number of events 1 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
0.00%
0/6 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
0.00%
0/6 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
16.7%
1/6 • Number of events 2 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
16.7%
1/6 • Number of events 1 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
|
Investigations
Vessel puncture site haematoma
|
16.7%
1/6 • Number of events 2 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
0.00%
0/6 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
0.00%
0/6 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
0.00%
0/6 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
|
General disorders
Vessel puncture site reaction
|
16.7%
1/6 • Number of events 1 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
0.00%
0/6 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
—
0/0 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
0.00%
0/6 • 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place