Trial Outcomes & Findings for A Phase 2/3 Study to Evaluate FP-025 in Patients With Severe to Critical COVID 19 (NCT NCT04750278)
NCT ID: NCT04750278
Last Updated: 2024-01-05
Results Overview
Percentage of patients alive and not requiring non-invasive or invasive ventilation at Day 28
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
90 participants
Primary outcome timeframe
Day 28
Results posted on
2024-01-05
Participant Flow
Participant milestones
| Measure |
FP-025 300 mg
High dose for patient treatment.
FP-025 300 mg: FP-025 300 mg BID
30 subjects
|
FP-025 100 mg
Low dose for patient treatment.
FP-025 100 mg: FP-025 100 mg BID
29 subjects
|
Placebo
Dose without any study drug, to make it a controlled study.
Placebo: Placebo BID
31 subjects
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
29
|
31
|
|
Overall Study
Completed D28 Visit
|
16
|
16
|
18
|
|
Overall Study
COMPLETED
|
15
|
13
|
15
|
|
Overall Study
NOT COMPLETED
|
15
|
16
|
16
|
Reasons for withdrawal
| Measure |
FP-025 300 mg
High dose for patient treatment.
FP-025 300 mg: FP-025 300 mg BID
30 subjects
|
FP-025 100 mg
Low dose for patient treatment.
FP-025 100 mg: FP-025 100 mg BID
29 subjects
|
Placebo
Dose without any study drug, to make it a controlled study.
Placebo: Placebo BID
31 subjects
|
|---|---|---|---|
|
Overall Study
Death
|
9
|
10
|
10
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Legally Authorized Representative
|
0
|
1
|
0
|
|
Overall Study
Non-compliance
|
0
|
0
|
1
|
|
Overall Study
Transfer to Outside Facility
|
0
|
2
|
1
|
|
Overall Study
Staff Inadvertently Failed to Follow up with Subject Visits
|
0
|
1
|
0
|
|
Overall Study
Patient Hospitalized Secondary to Unrelated SAE and Did Not Have Study Medication
|
0
|
0
|
1
|
Baseline Characteristics
A Phase 2/3 Study to Evaluate FP-025 in Patients With Severe to Critical COVID 19
Baseline characteristics by cohort
| Measure |
FP-025 100 mg
n=29 Participants
Low dose for patient treatment.
FP-025 100 mg: FP-025 100 mg BID
|
FP-025 300 mg
n=30 Participants
High dose for patient treatment.
FP-025 300 mg: FP-025 300 mg BID
|
Placebo
n=31 Participants
Dose without any study drug, to make it a controlled study.
Placebo: Placebo BID
|
Total
n=90 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
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Number of patients on mechanical ventilation
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 28Percentage of patients alive and not requiring non-invasive or invasive ventilation at Day 28
Outcome measures
| Measure |
FP-025 300 mg
n=30 Participants
High dose for patient treatment.
FP-025 300 mg: FP-025 300 mg BID
30 subjects
|
FP-025 100 mg
n=29 Participants
Low dose for patient treatment.
FP-025 100 mg: FP-025 100 mg BID
29 subjects
|
Placebo
n=31 Participants
Dose without any study drug, to make it a controlled study.
Placebo: Placebo BID
31 subjects
|
|---|---|---|---|
|
The Percentage of Patients Alive and Not Requiring Non-invasive or Invasive Ventilation
Meeting the primary efficacy endpoint
|
15 Participants
|
10 Participants
|
18 Participants
|
|
The Percentage of Patients Alive and Not Requiring Non-invasive or Invasive Ventilation
Not meeting the primary efficacy endpoint
|
15 Participants
|
19 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Day 28Percentage of patients on invasive mechanical ventilation at Day 28
Outcome measures
| Measure |
FP-025 300 mg
n=30 Participants
High dose for patient treatment.
FP-025 300 mg: FP-025 300 mg BID
30 subjects
|
FP-025 100 mg
n=29 Participants
Low dose for patient treatment.
FP-025 100 mg: FP-025 100 mg BID
29 subjects
|
Placebo
n=31 Participants
Dose without any study drug, to make it a controlled study.
Placebo: Placebo BID
31 subjects
|
|---|---|---|---|
|
Percentage of Patients on Invasive Mechanical Ventilation
Percentage of patients on invasive mechanical ventilation at Day 28
|
10 Participants
|
14 Participants
|
11 Participants
|
|
Percentage of Patients on Invasive Mechanical Ventilation
Percentage of patients not on invasive mechanical ventilation at Day 28
|
20 Participants
|
15 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Day 28Percentage of patients who are alive at the time of the assessment, day 28.
Outcome measures
| Measure |
FP-025 300 mg
n=30 Participants
High dose for patient treatment.
FP-025 300 mg: FP-025 300 mg BID
30 subjects
|
FP-025 100 mg
n=29 Participants
Low dose for patient treatment.
FP-025 100 mg: FP-025 100 mg BID
29 subjects
|
Placebo
n=31 Participants
Dose without any study drug, to make it a controlled study.
Placebo: Placebo BID
31 subjects
|
|---|---|---|---|
|
Percentage of Patients Alive
Percentage of patients not alive at Day 28
|
9 Participants
|
10 Participants
|
9 Participants
|
|
Percentage of Patients Alive
Percentage of patients alive at Day 28
|
21 Participants
|
19 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Day 60(ie, not receiving high flow nasal cannula, non-invasive positive pressure ventilation, invasive mechanical ventilation, or ECMO)
Outcome measures
| Measure |
FP-025 300 mg
n=30 Participants
High dose for patient treatment.
FP-025 300 mg: FP-025 300 mg BID
30 subjects
|
FP-025 100 mg
n=29 Participants
Low dose for patient treatment.
FP-025 100 mg: FP-025 100 mg BID
29 subjects
|
Placebo
n=31 Participants
Dose without any study drug, to make it a controlled study.
Placebo: Placebo BID
31 subjects
|
|---|---|---|---|
|
Percentage of Patients Alive and Not Requiring Non-invasive or Invasive Ventilation
|
12 Participants
|
10 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Day 60Percentage of patients receiving high flow nasal cannula, non-invasive positive pressure ventilation, invasive mechanical ventilation, or ECMO at day 60
Outcome measures
| Measure |
FP-025 300 mg
n=30 Participants
High dose for patient treatment.
FP-025 300 mg: FP-025 300 mg BID
30 subjects
|
FP-025 100 mg
n=29 Participants
Low dose for patient treatment.
FP-025 100 mg: FP-025 100 mg BID
29 subjects
|
Placebo
n=31 Participants
Dose without any study drug, to make it a controlled study.
Placebo: Placebo BID
31 subjects
|
|---|---|---|---|
|
Percentage of Patients on Invasive Mechanical Ventilation
Percentage of patients on invasive mechanical ventilation at Day 60
|
10 Participants
|
13 Participants
|
11 Participants
|
|
Percentage of Patients on Invasive Mechanical Ventilation
Percentage of patients not on invasive mechanical ventilation at Day 60
|
20 Participants
|
16 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Day 60Percentage of patients who continue to be alive at day 60.
Outcome measures
| Measure |
FP-025 300 mg
n=30 Participants
High dose for patient treatment.
FP-025 300 mg: FP-025 300 mg BID
30 subjects
|
FP-025 100 mg
n=29 Participants
Low dose for patient treatment.
FP-025 100 mg: FP-025 100 mg BID
29 subjects
|
Placebo
n=31 Participants
Dose without any study drug, to make it a controlled study.
Placebo: Placebo BID
31 subjects
|
|---|---|---|---|
|
Percentage of Patients Alive
Percentage of patients alive at Day 60
|
21 Participants
|
19 Participants
|
21 Participants
|
|
Percentage of Patients Alive
Percentage of patients not alive at Day 60
|
9 Participants
|
10 Participants
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 and Day 60Percentage of patients having lung fibrosis using high resolution, non-contrast CT scan, at days 28 and 60
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 and at Day 60Percentage of patients at days 28 and 60 who improved to breathing on their own, after having been on mechanical ventilation at some point during their treatment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 and Day 60Number of days (out of 28 and 60, respectively) that patient is off of mechanical ventilation.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 and Day 60Number of days (out of 28 and 60, respectively) that the patient is not in the ICU
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 and Day 60Number of days (out of 28 and 60, respectively) that the patient is hospitalized.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 and Day 60The number of percentage points the patient has changed in peripheral capillary oxygen saturation (SpO2) at days 28 and 60.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 and Day 60Change from baseline, at days 28 and 60, in arterial oxygen partial pressure .(PaO2)/fractional inspired oxygen (FiO2) ratio.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 and Day 60Percentage of patients at day 28 and day 60 who are alive and not hospitalized.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 and Day 60(defined as a ≥ 2 point decrease in the NIAID 8 point ordinal scale score or death)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 and Day 60Percentage of patients who improve by ≥ 2 points on the NIAID 8 point ordinal scale scores at Day 28 and Day 60
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 and Day 60Measured by Forced Expiratory Volume in 1 second (FEV1) /Forced Vital Capacity (FVC) at Day 28 and Day 60
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 and Day 60Change from baseline in eGFR at day 28 and day 60.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 and Day 60Change .from baseline in blood urea nitrogen at day 28 and day 60
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 and Day 60Change from baseline in serum creatinine at day 28 and day 60.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28 and Day 60Change from baseline in HRQoL as measured by the EQ 5D 5L at day 28 and day 60.
Outcome measures
Outcome data not reported
Adverse Events
FP-025 300 mg
Serious events: 11 serious events
Other events: 17 other events
Deaths: 9 deaths
FP-025 100 mg
Serious events: 12 serious events
Other events: 21 other events
Deaths: 10 deaths
Placebo
Serious events: 11 serious events
Other events: 19 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
FP-025 300 mg
n=30 participants at risk
High dose for patient treatment.
FP-025 300 mg: FP-025 300 mg BID
30 subjects
|
FP-025 100 mg
n=28 participants at risk
Low dose for patient treatment.
FP-025 100 mg: FP-025 100 mg BID
28 subjects
|
Placebo
n=30 participants at risk
Dose without any study drug, to make it a controlled study.
Placebo: Placebo BID
30 subjects
|
|---|---|---|---|
|
Infections and infestations
Infections and infestations
|
10.0%
3/30 • Number of events 3 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
14.3%
4/28 • Number of events 4 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
16.7%
5/30 • Number of events 5 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
|
Cardiac disorders
Cardiac Disorders
|
10.0%
3/30 • Number of events 3 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
17.9%
5/28 • Number of events 6 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
10.0%
3/30 • Number of events 6 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
13.3%
4/30 • Number of events 4 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
7.1%
2/28 • Number of events 2 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
6.7%
2/30 • Number of events 2 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
|
General disorders
General disorders and administration site conditions
|
0.00%
0/30 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
3.6%
1/28 • Number of events 1 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
3.3%
1/30 • Number of events 1 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
|
Vascular disorders
Vascular disorders
|
3.3%
1/30 • Number of events 1 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
0.00%
0/28 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
3.3%
1/30 • Number of events 1 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
0.00%
0/30 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
3.6%
1/28 • Number of events 1 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
0.00%
0/30 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy, puerperium and perinatal conditions
|
3.3%
1/30 • Number of events 1 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
0.00%
0/28 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
0.00%
0/30 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
|
Psychiatric disorders
Psychiatric disorders
|
0.00%
0/30 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
3.6%
1/28 • Number of events 1 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
0.00%
0/30 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
0.00%
0/30 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
0.00%
0/28 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
3.3%
1/30 • Number of events 1 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
Other adverse events
| Measure |
FP-025 300 mg
n=30 participants at risk
High dose for patient treatment.
FP-025 300 mg: FP-025 300 mg BID
30 subjects
|
FP-025 100 mg
n=28 participants at risk
Low dose for patient treatment.
FP-025 100 mg: FP-025 100 mg BID
28 subjects
|
Placebo
n=30 participants at risk
Dose without any study drug, to make it a controlled study.
Placebo: Placebo BID
30 subjects
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
26.7%
8/30 • Number of events 8 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
25.0%
7/28 • Number of events 10 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
16.7%
5/30 • Number of events 5 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
|
Infections and infestations
Infections and infestations
|
16.7%
5/30 • Number of events 6 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
25.0%
7/28 • Number of events 13 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
23.3%
7/30 • Number of events 9 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
|
Cardiac disorders
Cardiac disorders
|
16.7%
5/30 • Number of events 6 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
21.4%
6/28 • Number of events 9 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
16.7%
5/30 • Number of events 9 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
16.7%
5/30 • Number of events 8 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
10.7%
3/28 • Number of events 4 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
13.3%
4/30 • Number of events 7 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
10.0%
3/30 • Number of events 4 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
14.3%
4/28 • Number of events 5 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
10.0%
3/30 • Number of events 3 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
10.0%
3/30 • Number of events 3 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
10.7%
3/28 • Number of events 3 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
10.0%
3/30 • Number of events 3 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
|
Psychiatric disorders
Psychiatric disorders
|
6.7%
2/30 • Number of events 2 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
21.4%
6/28 • Number of events 6 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
0.00%
0/30 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
|
Vascular disorders
Vascular disorders
|
6.7%
2/30 • Number of events 6 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
14.3%
4/28 • Number of events 5 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
6.7%
2/30 • Number of events 2 • 60 days
Participants at Risk were considered to be participants in the safety population of the study. The safety population is defined as any participant who received at least one dose of study drug or placebo. This differs from the intent to treat population which is defined as any participant who was randomized to receive study drug or placebo. One (1) patient in the 100 mg group and one (1) patient in the placebo group did not receive study drug or placebo. Both patients withdrew consent.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place