Trial Outcomes & Findings for CC100: Safety and Tolerability of Single Doses (NCT NCT02050334)
NCT ID: NCT02050334
Last Updated: 2015-04-30
Results Overview
Safety and Tolerability assessed by arm/group and dose received measured by number of unsolicited AEs within a minimum of 24 hours after each dose.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Minimum of 24 hours after each dose.
Results posted on
2015-04-30
Participant Flow
Participant milestones
| Measure |
CC100 (3 Single Doses)
CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
CC100
|
CC100 (2 Single Doses) & Placebo(1 Dose)
CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
CC100
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CC100: Safety and Tolerability of Single Doses
Baseline characteristics by cohort
| Measure |
CC100 (3 Single Doses)
n=9 Participants
CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
CC100
|
CC100 (2 Single Doses) & Placebo(1 Dose)
n=9 Participants
CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
CC100
Placebo
|
Total
n=18 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
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Minimum of 24 hours after each dose.Population: All 18 subjects analyzed, per protocol.
Safety and Tolerability assessed by arm/group and dose received measured by number of unsolicited AEs within a minimum of 24 hours after each dose.
Outcome measures
| Measure |
CC100 (3 Single Doses)
n=9 Participants
CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
CC100
|
CC100 (2 Single Doses) & Placebo(1 Dose)
n=9 Participants
CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
CC100
Placebo
|
|---|---|---|
|
Unsolicited Adverse Event Reports
|
3 Unsolicited Adverse Event Reports
|
4 Unsolicited Adverse Event Reports
|
SECONDARY outcome
Timeframe: 0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100Population: 16 of 18 participants had data from drug level assays.The PK parameter analysis population included participants who received single CC100 dose(s) of 2, 5, 10, and/or 20 mg. Some PK parameters had fewer participants, if there were too few data points to analyze from a participant.
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Outcome measures
| Measure |
CC100 (3 Single Doses)
n=10 Participants
CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
CC100
|
CC100 (2 Single Doses) & Placebo(1 Dose)
CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
CC100
Placebo
|
|---|---|---|
|
Pharmacokinetics (PK)
|
2.7 hours
Standard Error 2.3
|
—
|
SECONDARY outcome
Timeframe: 0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100Population: 16 of 18 participants had data from drug level assays.The PK parameter analysis population included participants who received single CC100 dose(s) of 2, 5, 10, and/or 20 mg. Some PK parameters had fewer participants, if there were too few data points to analyze from a participant.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
CC100 (3 Single Doses)
n=10 Participants
CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
CC100
|
CC100 (2 Single Doses) & Placebo(1 Dose)
CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
CC100
Placebo
|
|---|---|---|
|
Half-Life (t1/2)
|
18.5 hours
Standard Error 14.2
|
—
|
Adverse Events
CC100 (3 Single Doses)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
CC100 (2 Single Doses) & Placebo(1 Dose)
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 |
CC100 (3 Single Doses)
n=9 participants at risk
CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
CC100
|
CC100 (2 Single Doses) & Placebo(1 Dose)
n=9 participants at risk
CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
CC100
Placebo
|
|---|---|---|
|
Nervous system disorders
Headache
|
11.1%
1/9
|
33.3%
3/9
|
|
Infections and infestations
urinary tract infections
|
11.1%
1/9
|
0.00%
0/9
|
|
Infections and infestations
Fever
|
0.00%
0/9
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9
|
0.00%
0/9
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place