Trial Outcomes & Findings for Evaluation of Safety & Tolerability of Multiple Dose Regimens of CHF 5074 (NCT NCT01303744)
NCT ID: NCT01303744
Last Updated: 2016-01-11
Results Overview
To assess if there were differences in ΔsCD40L levels between CHF 5074 doses and placebo
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
96 participants
Primary outcome timeframe
up to 12 weeks
Results posted on
2016-01-11
Participant Flow
Participant milestones
| Measure |
CHF 5074 1x
oral tablet, multidose
CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks
|
CHF 5074 2x
oral tablet, multidose
CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks
|
CHF 5074 3x
oral tablet, multidose
CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks
|
Placebo
placebo, oral tablet, multidose
Placebo: oral tablet, once a day in the morning for 12 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
24
|
24
|
|
Overall Study
COMPLETED
|
24
|
24
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Safety & Tolerability of Multiple Dose Regimens of CHF 5074
Baseline characteristics by cohort
| Measure |
CHF 5074 1x
n=24 Participants
oral tablet, multidose
CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks
|
CHF 5074 2x
n=24 Participants
oral tablet, multidose
CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks
|
CHF 5074 3x
n=24 Participants
oral tablet, multidose
CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks
|
Placebo
n=24 Participants
placebo, oral tablet, multidose
Placebo: oral tablet, once a day in the morning for 12 weeks
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67.7 years
STANDARD_DEVIATION 8.1 • n=99 Participants
|
68.9 years
STANDARD_DEVIATION 8.5 • n=107 Participants
|
69.0 years
STANDARD_DEVIATION 9.2 • n=206 Participants
|
68.1 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
68.4 years
STANDARD_DEVIATION 8.3 • n=31 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
40 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
56 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
92 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=99 Participants
|
24 participants
n=107 Participants
|
19 participants
n=206 Participants
|
24 participants
n=7 Participants
|
91 participants
n=31 Participants
|
|
Region of Enrollment
Italy
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
5 participants
n=206 Participants
|
0 participants
n=7 Participants
|
5 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: up to 12 weeksPopulation: ITT
To assess if there were differences in ΔsCD40L levels between CHF 5074 doses and placebo
Outcome measures
| Measure |
CHF 5074 1x
n=24 Participants
oral tablet, multidose
CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks
|
CHF 5074 2x
n=24 Participants
oral tablet, multidose
CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks
|
CHF 5074 3x
n=24 Participants
oral tablet, multidose
CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks
|
Placebo
n=24 Participants
placebo, oral tablet, multidose
Placebo: oral tablet, once a day in the morning for 12 weeks
|
|---|---|---|---|---|
|
Differences in ∆sCD40L Levels Between CHF 5074 Doses and Placebo at Any Specific Time Point
|
270.28 pg/ml
Standard Error 371.09
|
403.22 pg/ml
Standard Error 377.79
|
-1293.42 pg/ml
Standard Error 362.69
|
242.49 pg/ml
Standard Error 361.32
|
SECONDARY outcome
Timeframe: Days 85evaluate the pharmacokinetics (PK) of CHF 5074 in patients with MCI.
Outcome measures
| Measure |
CHF 5074 1x
n=24 Participants
oral tablet, multidose
CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks
|
CHF 5074 2x
n=20 Participants
oral tablet, multidose
CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks
|
CHF 5074 3x
n=20 Participants
oral tablet, multidose
CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks
|
Placebo
placebo, oral tablet, multidose
Placebo: oral tablet, once a day in the morning for 12 weeks
|
|---|---|---|---|---|
|
Measurement of Trough CHF 5074 Plasma Levels
|
5497 ng/ml
Standard Deviation 4940
|
7882 ng/ml
Standard Deviation 8231
|
19999 ng/ml
Standard Deviation 17474
|
—
|
SECONDARY outcome
Timeframe: 29 daysPopulation: ITT
Outcome measures
| Measure |
CHF 5074 1x
n=24 Participants
oral tablet, multidose
CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks
|
CHF 5074 2x
n=24 Participants
oral tablet, multidose
CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks
|
CHF 5074 3x
n=24 Participants
oral tablet, multidose
CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks
|
Placebo
n=24 Participants
placebo, oral tablet, multidose
Placebo: oral tablet, once a day in the morning for 12 weeks
|
|---|---|---|---|---|
|
Changes in Plasma ΔTNFα Concentrations
|
2.57 pg/ml
Standard Error 1.1
|
-0.339 pg/ml
Standard Error 1.09
|
-1.568 pg/ml
Standard Error 1.05
|
0.039 pg/ml
Standard Error 1.05
|
Adverse Events
CHF 5074 1x
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
CHF 5074 2x
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
CHF 5074 3x
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CHF 5074 1x
n=24 participants at risk
oral tablet, multidose
CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks
|
CHF 5074 2x
n=24 participants at risk
oral tablet, multidose
CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks
|
CHF 5074 3x
n=24 participants at risk
oral tablet, multidose
CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks
|
Placebo
n=24 participants at risk
placebo, oral tablet, multidose
Placebo: oral tablet, once a day in the morning for 12 weeks
|
|---|---|---|---|---|
|
Gastrointestinal disorders
intestinal obstruction
|
0.00%
0/24 • Trial duration
|
0.00%
0/24 • Trial duration
|
0.00%
0/24 • Trial duration
|
4.2%
1/24 • Number of events 1 • Trial duration
|
|
Cardiac disorders
Acute congestive heart failure
|
0.00%
0/24 • Trial duration
|
0.00%
0/24 • Trial duration
|
4.2%
1/24 • Number of events 1 • Trial duration
|
0.00%
0/24 • Trial duration
|
|
Cardiac disorders
cardiac failure congestive
|
4.2%
1/24 • Number of events 1 • Trial duration
|
0.00%
0/24 • Trial duration
|
0.00%
0/24 • Trial duration
|
0.00%
0/24 • Trial duration
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
4.2%
1/24 • Number of events 1 • Trial duration
|
0.00%
0/24 • Trial duration
|
0.00%
0/24 • Trial duration
|
0.00%
0/24 • Trial duration
|
|
Cardiac disorders
cerebrovascular accident
|
4.2%
1/24 • Number of events 1 • Trial duration
|
0.00%
0/24 • Trial duration
|
0.00%
0/24 • Trial duration
|
0.00%
0/24 • Trial duration
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
penis carcinoma
|
0.00%
0/24 • Trial duration
|
0.00%
0/24 • Trial duration
|
4.2%
1/24 • Number of events 1 • Trial duration
|
0.00%
0/24 • Trial duration
|
|
Musculoskeletal and connective tissue disorders
femur fracture
|
0.00%
0/24 • Trial duration
|
4.2%
1/24 • Number of events 1 • Trial duration
|
0.00%
0/24 • Trial duration
|
0.00%
0/24 • Trial duration
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
adenocarcinoma f transverse colon
|
0.00%
0/24 • Trial duration
|
4.2%
1/24 • Number of events 1 • Trial duration
|
0.00%
0/24 • Trial duration
|
0.00%
0/24 • Trial duration
|
Other adverse events
| Measure |
CHF 5074 1x
n=24 participants at risk
oral tablet, multidose
CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks
|
CHF 5074 2x
n=24 participants at risk
oral tablet, multidose
CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks
|
CHF 5074 3x
n=24 participants at risk
oral tablet, multidose
CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks
|
Placebo
n=24 participants at risk
placebo, oral tablet, multidose
Placebo: oral tablet, once a day in the morning for 12 weeks
|
|---|---|---|---|---|
|
Gastrointestinal disorders
diarrhoea
|
8.3%
2/24 • Number of events 2 • Trial duration
|
12.5%
3/24 • Number of events 7 • Trial duration
|
20.8%
5/24 • Number of events 5 • Trial duration
|
8.3%
2/24 • Number of events 2 • Trial duration
|
|
Metabolism and nutrition disorders
back pain
|
4.2%
1/24 • Number of events 1 • Trial duration
|
12.5%
3/24 • Number of events 3 • Trial duration
|
8.3%
2/24 • Number of events 3 • Trial duration
|
4.2%
1/24 • Number of events 1 • Trial duration
|
|
Nervous system disorders
Dizziness
|
4.2%
1/24 • Number of events 1 • Trial duration
|
8.3%
2/24 • Number of events 2 • Trial duration
|
12.5%
3/24 • Number of events 4 • Trial duration
|
4.2%
1/24 • Number of events 1 • Trial duration
|
|
General disorders
headache
|
4.2%
1/24 • Number of events 1 • Trial duration
|
8.3%
2/24 • Number of events 2 • Trial duration
|
0.00%
0/24 • Trial duration
|
8.3%
2/24 • Number of events 4 • Trial duration
|
|
Gastrointestinal disorders
nausea
|
4.2%
1/24 • Number of events 1 • Trial duration
|
16.7%
4/24 • Number of events 4 • Trial duration
|
0.00%
0/24 • Trial duration
|
0.00%
0/24 • Trial duration
|
|
Infections and infestations
Urinary tract infection
|
12.5%
3/24 • Number of events 5 • Trial duration
|
0.00%
0/24 • Trial duration
|
0.00%
0/24 • Trial duration
|
4.2%
1/24 • Number of events 2 • Trial duration
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/24 • Trial duration
|
8.3%
2/24 • Number of events 2 • Trial duration
|
4.2%
1/24 • Number of events 1 • Trial duration
|
0.00%
0/24 • Trial duration
|
|
Respiratory, thoracic and mediastinal disorders
nasopharyngitis
|
0.00%
0/24 • Trial duration
|
8.3%
2/24 • Number of events 2 • Trial duration
|
0.00%
0/24 • Trial duration
|
0.00%
0/24 • Trial duration
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place