Trial Outcomes & Findings for Safety, Dose Tolerance, Pharmacokinetics, and Pharmacodynamics Study of CPX-POM in Patients With Advanced Solid Tumors (NCT NCT03348514)
NCT ID: NCT03348514
Last Updated: 2021-12-03
Results Overview
The primary objective of this study is to evaluate the dose limiting toxicities (DLTs) of ciclopirox phosphoryloxymethyl ester (CPX-POM) administered intravenously (IV) and establish the CPX POM dose recommended for further investigation. A DLT will include some Grade 3 or 4 AEs (as assessed by CTCAE version 4.03) if deemed related to study drug. In addition, any patient who is unable to receive 80% of the expected dose of CPX-POM (i.e., patients who are unable to receive at least 4 of the 5 scheduled doses) because of AEs will be considered to have a DLT. In order to identify any DLTs, safety assessments including AEs, physical examinations, vital signs, and clinical laboratory tests will be conducted during each study visit through Day 22.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
19 participants
Primary outcome timeframe
Up to 22 days for each cohort
Results posted on
2021-12-03
Participant Flow
Participant milestones
| Measure |
CPX-POM - 30 mg/m^2
Period 1, Dose Cohort - 30 mg/m\^2
|
CPX-POM - 60 mg/m^2
Period 2, Dose Cohort - 60 mg/m\^2
|
CPX-POM - 120 mg/m^2
Period 3, Dose Cohort - 120 mg/m\^2
|
CPX-POM - 240 mg/m^2
Period 4, Dose Cohort - 240 mg/m\^2
|
CPX-POM - 360 mg/m^2
Period 5, Dose Cohort - 360 mg/m\^2
|
CPX-POM - 600 mg/m^2
Period 6, Dose Cohort - 600 mg/m\^2
|
CPX-POM - 900 mg/m^2
Period 7, Dose Cohort - 900 mg/m\^2
|
CPX-POM - 1200 mg/m^2
Period 8, Dose Cohort - 1200 mg/m\^2
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
1
|
3
|
4
|
6
|
2
|
|
Overall Study
COMPLETED
|
1
|
1
|
1
|
1
|
3
|
4
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Dose Tolerance, Pharmacokinetics, and Pharmacodynamics Study of CPX-POM in Patients With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
CPX-POM - 30 mg/m^2
n=1 Participants
Period1, Dose Cohort - 30 mg/m\^2
|
CPX-POM - 60 mg/m^2
n=1 Participants
Period 2, Dose Cohort - 60 mg/m\^2
|
CPX-POM - 120 mg/m^2
n=1 Participants
Period 3, Dose Cohort - 120 mg/m\^2
|
CPX-POM - 240 mg/m^2
n=1 Participants
Period 4, Dose Cohort - 240 mg/m\^2
|
CPX-POM - 360 mg/m^2
n=3 Participants
Period 5, Dose Cohort - 360 mg/m\^2
|
CPX-POM - 600 mg/m^2
n=4 Participants
Period 6, Dose Cohort - 600 mg/m\^2
|
CPX-POM - 900 mg/m^2
n=6 Participants
Period 7, Dose Cohort - 900 mg/m\^2
|
CPX-POM - 1200 mg/m^2
n=2 Participants
Period 8, Dose Cohort - 1200 mg/m\^2
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
46 years
n=93 Participants
|
62 years
n=4 Participants
|
76 years
n=27 Participants
|
61 years
n=483 Participants
|
54 years
n=36 Participants
|
63 years
n=10 Participants
|
60 years
n=115 Participants
|
82.5 years
n=40 Participants
|
63 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
13 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
6 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
18 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Cancer type
Colon
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
5 Participants
n=8 Participants
|
|
Cancer type
Bladder
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
|
Cancer type
Breast
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
|
Cancer type
Gastric
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
|
Cancer type
Head and Neck
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
|
Cancer type
Liver
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
|
Cancer type
Ovarian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
|
Cancer type
Prostate
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
|
Cancer type
Other
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
4 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 22 days for each cohortThe primary objective of this study is to evaluate the dose limiting toxicities (DLTs) of ciclopirox phosphoryloxymethyl ester (CPX-POM) administered intravenously (IV) and establish the CPX POM dose recommended for further investigation. A DLT will include some Grade 3 or 4 AEs (as assessed by CTCAE version 4.03) if deemed related to study drug. In addition, any patient who is unable to receive 80% of the expected dose of CPX-POM (i.e., patients who are unable to receive at least 4 of the 5 scheduled doses) because of AEs will be considered to have a DLT. In order to identify any DLTs, safety assessments including AEs, physical examinations, vital signs, and clinical laboratory tests will be conducted during each study visit through Day 22.
Outcome measures
| Measure |
CPX-POM - 30 mg/m^2
n=1 Participants
Period 1, Dose Cohort - 30 mg/m\^2
|
CPX-POM - 60 mg/m^2
n=1 Participants
Period 2, Dose Cohort - 60 mg/m\^2
|
CPX-POM - 120 mg/m^2
n=1 Participants
Period 3, Dose Cohort - 120 mg/m\^2
|
CPX-POM - 240 mg/m^2
n=1 Participants
Period 4, Dose Cohort - 240 mg/m\^2
|
CPX-POM - 360 mg/m^2
n=3 Participants
Period 5, Dose Cohort - 360 mg/m\^2
|
CPX-POM - 600 mg/m^2
n=4 Participants
Period 6, Dose Cohort - 600 mg/m\^2
|
CPX-POM - 900 mg/m^2
n=6 Participants
Period 7, Dose Cohort - 900 mg/m\^2
|
CPX-POM - 1200 mg/m^2
n=2 Participants
Period 8, Dose Cohort - 1200 mg/m\^2
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs) of CPX-POM
Grade 3
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Dose Limiting Toxicities (DLTs) of CPX-POM
Grade 1
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Days 1, 2, 3, 4, 5, 6, 10, 22 and 28The primary objective of this study is to evaluate the maximum tolerated dose (MTD) of ciclopirox phosphoryloxymethyl ester (CPX-POM) administered intravenously (IV) and establish the CPX POM dose recommended for further investigation. MTD was determined by testing increasing doses up to 1200 mg/m\^2 by IV. The MTD is defined as the dose BELOW that dose which causes DLTs in ≥33% of patients.
Outcome measures
| Measure |
CPX-POM - 30 mg/m^2
n=19 Participants
Period 1, Dose Cohort - 30 mg/m\^2
|
CPX-POM - 60 mg/m^2
Period 2, Dose Cohort - 60 mg/m\^2
|
CPX-POM - 120 mg/m^2
Period 3, Dose Cohort - 120 mg/m\^2
|
CPX-POM - 240 mg/m^2
Period 4, Dose Cohort - 240 mg/m\^2
|
CPX-POM - 360 mg/m^2
Period 5, Dose Cohort - 360 mg/m\^2
|
CPX-POM - 600 mg/m^2
Period 6, Dose Cohort - 600 mg/m\^2
|
CPX-POM - 900 mg/m^2
Period 7, Dose Cohort - 900 mg/m\^2
|
CPX-POM - 1200 mg/m^2
Period 8, Dose Cohort - 1200 mg/m\^2
|
|---|---|---|---|---|---|---|---|---|
|
Determine the Maximum Tolerated Dose (MTD) of CPX-POM
|
900 mg/m^2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 5-6Population: Pharmacokinetic data not obtained in one patient receiving 1200 mg/m\^2
Measure PK parameter Cmax (ng/mL)
Outcome measures
| Measure |
CPX-POM - 30 mg/m^2
n=1 Participants
Period 1, Dose Cohort - 30 mg/m\^2
|
CPX-POM - 60 mg/m^2
n=1 Participants
Period 2, Dose Cohort - 60 mg/m\^2
|
CPX-POM - 120 mg/m^2
n=1 Participants
Period 3, Dose Cohort - 120 mg/m\^2
|
CPX-POM - 240 mg/m^2
n=1 Participants
Period 4, Dose Cohort - 240 mg/m\^2
|
CPX-POM - 360 mg/m^2
n=3 Participants
Period 5, Dose Cohort - 360 mg/m\^2
|
CPX-POM - 600 mg/m^2
n=4 Participants
Period 6, Dose Cohort - 600 mg/m\^2
|
CPX-POM - 900 mg/m^2
n=6 Participants
Period 7, Dose Cohort - 900 mg/m\^2
|
CPX-POM - 1200 mg/m^2
n=1 Participants
Period 8, Dose Cohort - 1200 mg/m\^2
|
|---|---|---|---|---|---|---|---|---|
|
Assess Plasma PK: Cmax (ng/mL) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing.
|
371 ng/mL
|
1935 ng/mL
|
3491 ng/mL
|
6792 ng/mL
|
5297 ng/mL
Standard Deviation 1182
|
9457 ng/mL
Standard Deviation 512
|
17277 ng/mL
Standard Deviation 1913
|
15970 ng/mL
|
SECONDARY outcome
Timeframe: Days 5-6Population: Pharmacokinetic data not obtained in one patient receiving 1200 mg/m\^2
Determine Terminal Half-Life
Outcome measures
| Measure |
CPX-POM - 30 mg/m^2
n=1 Participants
Period 1, Dose Cohort - 30 mg/m\^2
|
CPX-POM - 60 mg/m^2
n=1 Participants
Period 2, Dose Cohort - 60 mg/m\^2
|
CPX-POM - 120 mg/m^2
n=1 Participants
Period 3, Dose Cohort - 120 mg/m\^2
|
CPX-POM - 240 mg/m^2
n=1 Participants
Period 4, Dose Cohort - 240 mg/m\^2
|
CPX-POM - 360 mg/m^2
n=3 Participants
Period 5, Dose Cohort - 360 mg/m\^2
|
CPX-POM - 600 mg/m^2
n=4 Participants
Period 6, Dose Cohort - 600 mg/m\^2
|
CPX-POM - 900 mg/m^2
n=6 Participants
Period 7, Dose Cohort - 900 mg/m\^2
|
CPX-POM - 1200 mg/m^2
n=1 Participants
Period 8, Dose Cohort - 1200 mg/m\^2
|
|---|---|---|---|---|---|---|---|---|
|
Assess Plasma PK: Terminal Half-life of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing.
|
2.34 hours
|
0.54 hours
|
5.56 hours
|
3.34 hours
|
3.12 hours
Standard Deviation 1.34
|
4.61 hours
Standard Deviation 1.46
|
8.30 hours
Standard Deviation 2.63
|
7.43 hours
|
SECONDARY outcome
Timeframe: Days 5-6Population: Pharmacokinetic data not obtained in one patient receiving 1200 mg/m\^2
Measure PK parameter area-under-the-plasma-drug/metabolite-concentration-time curve (ng/mL/hr) following single dose (AUC) and at steady-state AUCss following single and repeat drug administration.
Outcome measures
| Measure |
CPX-POM - 30 mg/m^2
n=1 Participants
Period 1, Dose Cohort - 30 mg/m\^2
|
CPX-POM - 60 mg/m^2
n=1 Participants
Period 2, Dose Cohort - 60 mg/m\^2
|
CPX-POM - 120 mg/m^2
n=1 Participants
Period 3, Dose Cohort - 120 mg/m\^2
|
CPX-POM - 240 mg/m^2
n=1 Participants
Period 4, Dose Cohort - 240 mg/m\^2
|
CPX-POM - 360 mg/m^2
n=3 Participants
Period 5, Dose Cohort - 360 mg/m\^2
|
CPX-POM - 600 mg/m^2
n=4 Participants
Period 6, Dose Cohort - 600 mg/m\^2
|
CPX-POM - 900 mg/m^2
n=6 Participants
Period 7, Dose Cohort - 900 mg/m\^2
|
CPX-POM - 1200 mg/m^2
n=1 Participants
Period 8, Dose Cohort - 1200 mg/m\^2
|
|---|---|---|---|---|---|---|---|---|
|
Assess Plasma PK: AUCss (ng/mL/hr) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing.
Single Dose AUCs
|
589 ng*hr/mL
|
1262 ng*hr/mL
|
3736 ng*hr/mL
|
4622 ng*hr/mL
|
4731 ng*hr/mL
Standard Deviation 1310
|
11914 ng*hr/mL
Standard Deviation 1852
|
24148 ng*hr/mL
Standard Deviation 6067
|
34470 ng*hr/mL
|
|
Assess Plasma PK: AUCss (ng/mL/hr) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing.
Steady State AUCss
|
515 ng*hr/mL
|
1328 ng*hr/mL
|
5143 ng*hr/mL
|
6000 ng*hr/mL
|
4856 ng*hr/mL
Standard Deviation 910
|
12484 ng*hr/mL
Standard Deviation 1182
|
23414 ng*hr/mL
Standard Deviation 1913
|
28048 ng*hr/mL
|
SECONDARY outcome
Timeframe: Days 5-6Population: Pharmacokinetic data not obtained in one patient receiving 1200 mg/m\^2
Measure PK parameter Cls (mL/hr/kg) - systemic clearance following single dose (Cls) following single and repeat drug administration.
Outcome measures
| Measure |
CPX-POM - 30 mg/m^2
n=1 Participants
Period 1, Dose Cohort - 30 mg/m\^2
|
CPX-POM - 60 mg/m^2
n=1 Participants
Period 2, Dose Cohort - 60 mg/m\^2
|
CPX-POM - 120 mg/m^2
n=1 Participants
Period 3, Dose Cohort - 120 mg/m\^2
|
CPX-POM - 240 mg/m^2
n=1 Participants
Period 4, Dose Cohort - 240 mg/m\^2
|
CPX-POM - 360 mg/m^2
n=3 Participants
Period 5, Dose Cohort - 360 mg/m\^2
|
CPX-POM - 600 mg/m^2
n=4 Participants
Period 6, Dose Cohort - 600 mg/m\^2
|
CPX-POM - 900 mg/m^2
n=6 Participants
Period 7, Dose Cohort - 900 mg/m\^2
|
CPX-POM - 1200 mg/m^2
n=1 Participants
Period 8, Dose Cohort - 1200 mg/m\^2
|
|---|---|---|---|---|---|---|---|---|
|
Assess Plasma PK: Cls (mL/hr/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing.
Single Dose Cls
|
614 mL/hr/kg
|
581 mL/hr/kg
|
361 mL/hr/kg
|
515 mL/hr/kg
|
1065 mL/hr/kg
Standard Deviation 435
|
507 mL/hr/kg
Standard Deviation 95
|
432 mL/hr/kg
Standard Deviation 142
|
375 mL/hr/kg
|
|
Assess Plasma PK: Cls (mL/hr/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing.
Steady State Cls
|
702 mL/hr/kg
|
552 mL/hr/kg
|
262 mL/hr/kg
|
397 mL/hr/kg
|
963 mL/hr/kg
Standard Deviation 271
|
471 mL/hr/kg
Standard Deviation 113
|
421 mL/hr/kg
Standard Deviation 184
|
456 mL/hr/kg
|
SECONDARY outcome
Timeframe: Days 5-6Population: Pharmacokinetic data not obtained in one patient receiving 1200 mg/m\^2
Measure PK parameters Vd (apparent volume of distribution) and Vss (steady state volume of distribution) (mL/kg)
Outcome measures
| Measure |
CPX-POM - 30 mg/m^2
n=1 Participants
Period 1, Dose Cohort - 30 mg/m\^2
|
CPX-POM - 60 mg/m^2
n=1 Participants
Period 2, Dose Cohort - 60 mg/m\^2
|
CPX-POM - 120 mg/m^2
n=1 Participants
Period 3, Dose Cohort - 120 mg/m\^2
|
CPX-POM - 240 mg/m^2
n=1 Participants
Period 4, Dose Cohort - 240 mg/m\^2
|
CPX-POM - 360 mg/m^2
n=3 Participants
Period 5, Dose Cohort - 360 mg/m\^2
|
CPX-POM - 600 mg/m^2
n=4 Participants
Period 6, Dose Cohort - 600 mg/m\^2
|
CPX-POM - 900 mg/m^2
n=6 Participants
Period 7, Dose Cohort - 900 mg/m\^2
|
CPX-POM - 1200 mg/m^2
n=1 Participants
Period 8, Dose Cohort - 1200 mg/m\^2
|
|---|---|---|---|---|---|---|---|---|
|
Assess Plasma PK: Vd and Vss (mL/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing.
Vd
|
2370 mL/kg
|
429 mL/kg
|
2100 mL/kg
|
1966 mL/kg
|
4522 mL/kg
Standard Deviation 2715
|
3090 mL/kg
Standard Deviation 1015
|
5340 mL/kg
Standard Deviation 3935
|
4887 mL/kg
|
|
Assess Plasma PK: Vd and Vss (mL/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing.
Vss
|
2053 mL/kg
|
473 mL/kg
|
1633 mL/kg
|
736 mL/kg
|
1986 mL/kg
Standard Deviation 802
|
1346 mL/kg
Standard Deviation 349
|
2261 mL/kg
Standard Deviation 1249
|
2518 mL/kg
|
SECONDARY outcome
Timeframe: Days 5-6Population: Pharmacokinetic data not obtained in one patient receiving 1200 mg/m\^2
Determine PK parameter AUC derived accumulation ratio (AUCss/AUCi ratio)
Outcome measures
| Measure |
CPX-POM - 30 mg/m^2
n=1 Participants
Period 1, Dose Cohort - 30 mg/m\^2
|
CPX-POM - 60 mg/m^2
n=1 Participants
Period 2, Dose Cohort - 60 mg/m\^2
|
CPX-POM - 120 mg/m^2
n=1 Participants
Period 3, Dose Cohort - 120 mg/m\^2
|
CPX-POM - 240 mg/m^2
n=1 Participants
Period 4, Dose Cohort - 240 mg/m\^2
|
CPX-POM - 360 mg/m^2
n=3 Participants
Period 5, Dose Cohort - 360 mg/m\^2
|
CPX-POM - 600 mg/m^2
n=4 Participants
Period 6, Dose Cohort - 600 mg/m\^2
|
CPX-POM - 900 mg/m^2
n=6 Participants
Period 7, Dose Cohort - 900 mg/m\^2
|
CPX-POM - 1200 mg/m^2
n=1 Participants
Period 8, Dose Cohort - 1200 mg/m\^2
|
|---|---|---|---|---|---|---|---|---|
|
Characterize Plasma PK: AUCss/AUCi Accumulation Ratio of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing.
|
0.86 ratio
|
1.05 ratio
|
1.59 ratio
|
1.30 ratio
|
1.08 ratio
Standard Deviation 0.14
|
1.09 ratio
Standard Deviation 0.17
|
1.03 ratio
Standard Deviation 0.29
|
0.81 ratio
|
SECONDARY outcome
Timeframe: Days 5-6Population: Urine pharmacokinetic data not obtained in one patient receiving 600 mg/m\^2 and one patient receiving 1200 mg/m\^2
Measure Percent Dose (%)
Outcome measures
| Measure |
CPX-POM - 30 mg/m^2
n=1 Participants
Period 1, Dose Cohort - 30 mg/m\^2
|
CPX-POM - 60 mg/m^2
n=1 Participants
Period 2, Dose Cohort - 60 mg/m\^2
|
CPX-POM - 120 mg/m^2
n=1 Participants
Period 3, Dose Cohort - 120 mg/m\^2
|
CPX-POM - 240 mg/m^2
n=1 Participants
Period 4, Dose Cohort - 240 mg/m\^2
|
CPX-POM - 360 mg/m^2
n=3 Participants
Period 5, Dose Cohort - 360 mg/m\^2
|
CPX-POM - 600 mg/m^2
n=3 Participants
Period 6, Dose Cohort - 600 mg/m\^2
|
CPX-POM - 900 mg/m^2
n=6 Participants
Period 7, Dose Cohort - 900 mg/m\^2
|
CPX-POM - 1200 mg/m^2
n=1 Participants
Period 8, Dose Cohort - 1200 mg/m\^2
|
|---|---|---|---|---|---|---|---|---|
|
Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing.
% CPX-POM Dose Excreted as ciclopirox glucuronide over 24 hours
|
59.74 Percent of CPX-POM dose
|
69.73 Percent of CPX-POM dose
|
70.21 Percent of CPX-POM dose
|
73.86 Percent of CPX-POM dose
|
75.99 Percent of CPX-POM dose
Standard Deviation 10.40
|
50.70 Percent of CPX-POM dose
Standard Deviation 29.28
|
69.62 Percent of CPX-POM dose
Standard Deviation 15.16
|
68.19 Percent of CPX-POM dose
|
|
Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing.
% CPX-POM Dose Excreted as CPX-POM over 24 hours
|
0 Percent of CPX-POM dose
Standard Deviation 0
|
0 Percent of CPX-POM dose
Standard Deviation 0
|
0 Percent of CPX-POM dose
Standard Deviation 0
|
0 Percent of CPX-POM dose
Standard Deviation 0
|
0 Percent of CPX-POM dose
Standard Deviation 0
|
0 Percent of CPX-POM dose
Standard Deviation 0
|
0 Percent of CPX-POM dose
Standard Deviation 0
|
0 Percent of CPX-POM dose
Standard Deviation 0
|
|
Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing.
% CPX-POM Dose Excreted as ciclopirox over 24 hours
|
0.81 Percent of CPX-POM dose
|
0.82 Percent of CPX-POM dose
|
1.74 Percent of CPX-POM dose
|
1.25 Percent of CPX-POM dose
|
0.80 Percent of CPX-POM dose
Standard Deviation 0.21
|
1.21 Percent of CPX-POM dose
Standard Deviation 0.11
|
4.42 Percent of CPX-POM dose
Standard Deviation 4.68
|
2.89 Percent of CPX-POM dose
|
SECONDARY outcome
Timeframe: Days 5-6Population: Urine pharmacokinetic data not obtained in one patient receiving 600 mg/m\^2 and one patient receiving 1200 mg/m\^2
Measure urine CPX concentration (uM)
Outcome measures
| Measure |
CPX-POM - 30 mg/m^2
n=1 Participants
Period 1, Dose Cohort - 30 mg/m\^2
|
CPX-POM - 60 mg/m^2
n=1 Participants
Period 2, Dose Cohort - 60 mg/m\^2
|
CPX-POM - 120 mg/m^2
n=1 Participants
Period 3, Dose Cohort - 120 mg/m\^2
|
CPX-POM - 240 mg/m^2
n=1 Participants
Period 4, Dose Cohort - 240 mg/m\^2
|
CPX-POM - 360 mg/m^2
n=3 Participants
Period 5, Dose Cohort - 360 mg/m\^2
|
CPX-POM - 600 mg/m^2
n=3 Participants
Period 6, Dose Cohort - 600 mg/m\^2
|
CPX-POM - 900 mg/m^2
n=6 Participants
Period 7, Dose Cohort - 900 mg/m\^2
|
CPX-POM - 1200 mg/m^2
n=1 Participants
Period 8, Dose Cohort - 1200 mg/m\^2
|
|---|---|---|---|---|---|---|---|---|
|
Assess Urine PK: Average 24-hour Urine Concentration of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing.
|
0.65 uM
|
0.84 uM
|
10.77 uM
|
3.93 uM
|
5.10 uM
Standard Deviation 0.86
|
22.91 uM
Standard Deviation 12.83
|
138.17 uM
Standard Deviation 157.97
|
208.65 uM
|
Adverse Events
CPX-POM - 30 mg/m^2
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
CPX-POM - 60 mg/m^2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CPX-POM - 120 mg/m^2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
CPX-POM - 240 mg/m^2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
CPX-POM - 360 mg/m^2
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
CPX-POM - 600 mg/m^2
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
CPX-POM - 900 mg/m^2
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
CPX-POM - 1200 mg/m^2
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CPX-POM - 30 mg/m^2
n=1 participants at risk
Period 1, Dose Cohort - 30 mg/m\^2
|
CPX-POM - 60 mg/m^2
n=1 participants at risk
Period 2, Dose Cohort - 60 mg/m\^2
|
CPX-POM - 120 mg/m^2
n=1 participants at risk
Period 3, Dose Cohort - 120 mg/m\^2
|
CPX-POM - 240 mg/m^2
n=1 participants at risk
Period 4, Dose Cohort - 240 mg/m\^2
|
CPX-POM - 360 mg/m^2
n=3 participants at risk
Period 5, Dose Cohort - 360 mg/m\^2
|
CPX-POM - 600 mg/m^2
n=4 participants at risk
Period 6, Dose Cohort - 600 mg/m\^2
|
CPX-POM - 900 mg/m^2
n=6 participants at risk
Period 7 Dose Cohort - 900 mg/m\^2
|
CPX-POM - 1200 mg/m^2
n=2 participants at risk
Period 8, Dose Cohort - 1200 mg/m\^2
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
100.0%
1/1 • Number of events 1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
0.00%
0/4 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/2 • 28 days
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
25.0%
1/4 • Number of events 1 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/2 • 28 days
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
25.0%
1/4 • Number of events 1 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/2 • 28 days
|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
25.0%
1/4 • Number of events 1 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/2 • 28 days
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
25.0%
1/4 • Number of events 1 • 28 days
|
0.00%
0/6 • 28 days
|
50.0%
1/2 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
0.00%
0/4 • 28 days
|
16.7%
1/6 • Number of events 1 • 28 days
|
0.00%
0/2 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
33.3%
1/3 • Number of events 1 • 28 days
|
0.00%
0/4 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/2 • 28 days
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
0.00%
0/4 • 28 days
|
0.00%
0/6 • 28 days
|
50.0%
1/2 • Number of events 1 • 28 days
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
0.00%
0/4 • 28 days
|
16.7%
1/6 • Number of events 1 • 28 days
|
0.00%
0/2 • 28 days
|
|
Investigations
Hyperbilirubinaemia
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
25.0%
1/4 • Number of events 1 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/2 • 28 days
|
Other adverse events
| Measure |
CPX-POM - 30 mg/m^2
n=1 participants at risk
Period 1, Dose Cohort - 30 mg/m\^2
|
CPX-POM - 60 mg/m^2
n=1 participants at risk
Period 2, Dose Cohort - 60 mg/m\^2
|
CPX-POM - 120 mg/m^2
n=1 participants at risk
Period 3, Dose Cohort - 120 mg/m\^2
|
CPX-POM - 240 mg/m^2
n=1 participants at risk
Period 4, Dose Cohort - 240 mg/m\^2
|
CPX-POM - 360 mg/m^2
n=3 participants at risk
Period 5, Dose Cohort - 360 mg/m\^2
|
CPX-POM - 600 mg/m^2
n=4 participants at risk
Period 6, Dose Cohort - 600 mg/m\^2
|
CPX-POM - 900 mg/m^2
n=6 participants at risk
Period 7 Dose Cohort - 900 mg/m\^2
|
CPX-POM - 1200 mg/m^2
n=2 participants at risk
Period 8, Dose Cohort - 1200 mg/m\^2
|
|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
100.0%
1/1 • Number of events 1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
0.00%
0/4 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/2 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
0.00%
0/4 • 28 days
|
0.00%
0/6 • 28 days
|
50.0%
1/2 • Number of events 1 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
0.00%
0/4 • 28 days
|
0.00%
0/6 • 28 days
|
50.0%
1/2 • Number of events 1 • 28 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
33.3%
1/3 • Number of events 1 • 28 days
|
0.00%
0/4 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/2 • 28 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
0.00%
0/4 • 28 days
|
0.00%
0/6 • 28 days
|
50.0%
1/2 • Number of events 1 • 28 days
|
|
Vascular disorders
Flushing
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
0.00%
0/4 • 28 days
|
16.7%
1/6 • Number of events 1 • 28 days
|
50.0%
1/2 • Number of events 1 • 28 days
|
|
Eye disorders
Vision blurred
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
0.00%
0/4 • 28 days
|
16.7%
1/6 • Number of events 1 • 28 days
|
0.00%
0/2 • 28 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
0.00%
0/4 • 28 days
|
16.7%
1/6 • Number of events 1 • 28 days
|
0.00%
0/2 • 28 days
|
|
Nervous system disorders
Taste Disorder
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
25.0%
1/4 • Number of events 1 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/2 • 28 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
33.3%
1/3 • Number of events 1 • 28 days
|
0.00%
0/4 • 28 days
|
66.7%
4/6 • Number of events 4 • 28 days
|
50.0%
1/2 • Number of events 1 • 28 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
100.0%
1/1 • Number of events 1 • 28 days
|
33.3%
1/3 • Number of events 1 • 28 days
|
50.0%
2/4 • Number of events 2 • 28 days
|
16.7%
1/6 • Number of events 1 • 28 days
|
0.00%
0/2 • 28 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
0.00%
0/4 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/2 • 28 days
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
0.00%
0/4 • 28 days
|
16.7%
1/6 • Number of events 1 • 28 days
|
0.00%
0/2 • 28 days
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
0.00%
0/4 • 28 days
|
16.7%
1/6 • Number of events 1 • 28 days
|
0.00%
0/2 • 28 days
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
0.00%
0/4 • 28 days
|
16.7%
1/6 • Number of events 1 • 28 days
|
0.00%
0/2 • 28 days
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
25.0%
1/4 • Number of events 1 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/2 • 28 days
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
50.0%
2/4 • Number of events 2 • 28 days
|
33.3%
2/6 • Number of events 2 • 28 days
|
50.0%
1/2 • Number of events 1 • 28 days
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
25.0%
1/4 • Number of events 1 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/2 • 28 days
|
|
General disorders
Fatigue
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
100.0%
1/1 • Number of events 1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
25.0%
1/4 • Number of events 1 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/2 • 28 days
|
|
General disorders
Chills
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
25.0%
1/4 • Number of events 1 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/2 • 28 days
|
|
General disorders
Feeling hot
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
0.00%
0/4 • 28 days
|
0.00%
0/6 • 28 days
|
50.0%
1/2 • Number of events 1 • 28 days
|
|
General disorders
Non cardiac chest pain
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
0.00%
0/4 • 28 days
|
0.00%
0/6 • 28 days
|
50.0%
1/2 • Number of events 1 • 28 days
|
|
Nervous system disorders
Amnesia
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
25.0%
1/4 • Number of events 1 • 28 days
|
0.00%
0/6 • 28 days
|
50.0%
1/2 • Number of events 1 • 28 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
25.0%
1/4 • Number of events 1 • 28 days
|
0.00%
0/6 • 28 days
|
50.0%
1/2 • Number of events 1 • 28 days
|
|
Nervous system disorders
Somnolence
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
25.0%
1/4 • Number of events 1 • 28 days
|
16.7%
1/6 • Number of events 1 • 28 days
|
0.00%
0/2 • 28 days
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
0.00%
0/4 • 28 days
|
0.00%
0/6 • 28 days
|
50.0%
1/2 • Number of events 1 • 28 days
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
0.00%
0/4 • 28 days
|
16.7%
1/6 • Number of events 1 • 28 days
|
0.00%
0/2 • 28 days
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
0.00%
0/4 • 28 days
|
16.7%
1/6 • Number of events 1 • 28 days
|
50.0%
1/2 • Number of events 1 • 28 days
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
25.0%
1/4 • Number of events 1 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/2 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/1 • 28 days
|
0.00%
0/3 • 28 days
|
25.0%
1/4 • Number of events 1 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/2 • 28 days
|
Additional Information
Dr. John A Taylor III
University of Kansas Medical Center
Phone: 913-588-8170
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place