Trial Outcomes & Findings for Dose-Escalate Study to Investigate the Safety and Tolerability of T89 in Japanese (NCT NCT01679028)
NCT ID: NCT01679028
Last Updated: 2014-11-24
Results Overview
the Incidence of Adverse Drug Events and serious adverse events
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
30 days (after first dosing)
Results posted on
2014-11-24
Participant Flow
Study Initiation Date: Auguest 1st, 2012 Study Completion Date: October 20th, 2012 Location: Phase I clinical Study Center: California Clinical Trials Medical Group 1509 Wilson Terrace Glendale, CA 91206
Participant milestones
| Measure |
Placebo Group A
Placebo 150mg single dose
|
T89 Group A
T89 150mg single dose
|
Placebo Group B
Placebo 300mg single dose
|
T89 Group B
T89 300mg single dose
|
Placebo Group C
Placebo 225mg bid for 14 days
|
T89 Group C
T89 225mg bid for 14 days
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
4
|
2
|
4
|
2
|
6
|
|
Overall Study
COMPLETED
|
2
|
4
|
2
|
4
|
2
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose-Escalate Study to Investigate the Safety and Tolerability of T89 in Japanese
Baseline characteristics by cohort
| Measure |
Placebo Group A
n=2 Participants
Placebo 150mg single dose
|
T89 Group A
n=4 Participants
T89 150mg single dose
|
Placebo Group B
n=2 Participants
Placebo 300mg single dose
|
T89 Group B
n=4 Participants
T89 300mg single dose
|
Placebo Group C
n=2 Participants
Placebo 225mg bid for 14 days
|
T89 Group C
n=6 Participants
T89 225mg bid for 14 days
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
27 years
STANDARD_DEVIATION 3 • n=5 Participants
|
24 years
STANDARD_DEVIATION 2 • n=7 Participants
|
24.5 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
24 years
STANDARD_DEVIATION 2.2 • n=4 Participants
|
47.5 years
STANDARD_DEVIATION 6.4 • n=21 Participants
|
40.6 years
STANDARD_DEVIATION 9.9 • n=10 Participants
|
32.5 years
STANDARD_DEVIATION 11.0 • n=115 Participants
|
|
Sex: Female, Male
Female
|
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
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
2 participants
n=21 Participants
|
6 participants
n=10 Participants
|
20 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 30 days (after first dosing)the Incidence of Adverse Drug Events and serious adverse events
Outcome measures
| Measure |
Placebo Group A
n=2 Participants
150 mg placebo; single dose
|
T89 Group A
n=4 Participants
150mg T89; Single dose
|
Placebo Group B
n=2 Participants
300mg Placebo; single dose
|
T89 Group B
n=4 Participants
300mg T89; single dose
|
Placebo Group C
n=2 Participants
225mg bid for 10 days
|
T89 Group C
n=6 Participants
T89 225mg bid for 10 days
|
|---|---|---|---|---|---|---|
|
Incidence of Adverse Drug Events and Serious Adverse Events
|
0 adverse event
|
0 adverse event
|
0 adverse event
|
0 adverse event
|
0 adverse event
|
1 adverse event
|
Adverse Events
Placebo Group A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
T89 Group A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Group B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
T89 Group B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Group C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
T89 Group C
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Group A
n=2 participants at risk
150 mg Placebo Single dose
|
T89 Group A
n=4 participants at risk
150mg T89 single dose
|
Placebo Group B
n=2 participants at risk
300mg Placebo single dose
|
T89 Group B
n=4 participants at risk
300mg T89 single dose
|
Placebo Group C
n=2 participants at risk
Placebo 225mg bid for 14 days
|
T89 Group C
n=6 participants at risk
T89 225mf bid for 14 days
|
|---|---|---|---|---|---|---|
|
General disorders
Somnolence
|
0.00%
0/2 • 30 days after the last dose.
|
0.00%
0/4 • 30 days after the last dose.
|
0.00%
0/2 • 30 days after the last dose.
|
0.00%
0/4 • 30 days after the last dose.
|
0.00%
0/2 • 30 days after the last dose.
|
16.7%
1/6 • 30 days after the last dose.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI can be co-authored with sponsor for the publication but cannot publish the result solely.
- Publication restrictions are in place
Restriction type: OTHER