Trial Outcomes & Findings for Safety, Tolerability and PK of Multiple-ascending Doses of Emodepside (NCT NCT03383614)
NCT ID: NCT03383614
Last Updated: 2020-04-15
Results Overview
Death, serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs).
COMPLETED
PHASE1
24 participants
up to 120 days
2020-04-15
Participant Flow
24 healthy subjects were randomized and received study drug or matching placebo.
Participant milestones
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
5
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Includes only those subjects who drank alcohol-containing beverages.
Baseline characteristics by cohort
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
n=6 Participants
6 subjects with matching placebo (2 subjects per dose group)
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
24 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
|
Age, Continuous
|
31.0 years
n=6 Participants
|
33.3 years
n=6 Participants
|
28.0 years
n=6 Participants
|
32.7 years
n=6 Participants
|
31.3 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
24 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
24 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
24 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
24 participants
n=24 Participants
|
|
Height
|
179.3 cm
STANDARD_DEVIATION 4.18 • n=6 Participants
|
179.7 cm
STANDARD_DEVIATION 4.59 • n=6 Participants
|
181.8 cm
STANDARD_DEVIATION 6.74 • n=6 Participants
|
182.7 cm
STANDARD_DEVIATION 8.80 • n=6 Participants
|
180.9 cm
STANDARD_DEVIATION 6.10 • n=24 Participants
|
|
Weight
|
72.18 kg
STANDARD_DEVIATION 6.204 • n=6 Participants
|
77.70 kg
STANDARD_DEVIATION 17.570 • n=6 Participants
|
75.23 kg
STANDARD_DEVIATION 9.520 • n=6 Participants
|
74.73 kg
STANDARD_DEVIATION 8.999 • n=6 Participants
|
74.96 kg
STANDARD_DEVIATION 10.807 • n=24 Participants
|
|
BMI
|
22.48 kg/m^2
STANDARD_DEVIATION 2.520 • n=6 Participants
|
23.88 kg/m^2
STANDARD_DEVIATION 4.392 • n=6 Participants
|
22.72 kg/m^2
STANDARD_DEVIATION 2.111 • n=6 Participants
|
22.33 kg/m^2
STANDARD_DEVIATION 0.882 • n=6 Participants
|
22.85 kg/m^2
STANDARD_DEVIATION 2.664 • n=24 Participants
|
|
Smokers
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=24 Participants
|
|
Weekly alcohol consumption (units)
|
8.3 units/week
STANDARD_DEVIATION 3.79 • n=3 Participants • Includes only those subjects who drank alcohol-containing beverages.
|
3.3 units/week
STANDARD_DEVIATION 2.31 • n=3 Participants • Includes only those subjects who drank alcohol-containing beverages.
|
7.0 units/week
STANDARD_DEVIATION 3.46 • n=4 Participants • Includes only those subjects who drank alcohol-containing beverages.
|
5.8 units/week
STANDARD_DEVIATION 2.17 • n=5 Participants • Includes only those subjects who drank alcohol-containing beverages.
|
6.1 units/week
STANDARD_DEVIATION 3.11 • n=15 Participants • Includes only those subjects who drank alcohol-containing beverages.
|
|
Xanthine
|
441.7 mL/day
STANDARD_DEVIATION 245.80 • n=6 Participants • Includes only those subjects who drank xanthine-containing beverages.
|
562.5 mL/day
STANDARD_DEVIATION 239.36 • n=4 Participants • Includes only those subjects who drank xanthine-containing beverages.
|
283.3 mL/day
STANDARD_DEVIATION 104.08 • n=3 Participants • Includes only those subjects who drank xanthine-containing beverages.
|
300.0 mL/day
STANDARD_DEVIATION 122.47 • n=6 Participants • Includes only those subjects who drank xanthine-containing beverages.
|
397.4 mL/day
STANDARD_DEVIATION 209.15 • n=19 Participants • Includes only those subjects who drank xanthine-containing beverages.
|
PRIMARY outcome
Timeframe: up to 120 daysPopulation: Adverse events were determined in the Safety population. Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days). AE=adverse event; OD=once daily; BID=twice daily.
Death, serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs).
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
n=6 Participants
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With Adverse Events
AEs
|
5 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With Adverse Events
TEAEs
|
5 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With Adverse Events
Drug-related TEAEs
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With Adverse Events
SAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With Adverse Events
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With Adverse Events
Withdrawals from the study owing to a TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 120 daysPopulation: Adverse events were determined in the Safety population. Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days). AE=adverse event; OD=once daily; BID=twice daily.
Number of subjects with a TEAE, by highest level of severity.
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
n=6 Participants
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Adverse Event Severity
Mild
|
2 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Adverse Event Severity
Moderate
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Adverse Event Severity
Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: up to 120 daysPopulation: Vital signs were measured pre-dose on Day -1, at regular time points until Follow-up (Day 30), and at each long-term follow-up visit. OD=once daily; BID=twice daily; HR=heart rate; BP=blood pressure.
Vital signs included heart rate, systolic and diastolic blood pressure and temperature.
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
n=6 Participants
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With Vital Signs Findings
Clinically significant change in HR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With Vital Signs Findings
Clinically significant change in systolic BP
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With Vital Signs Findings
Clinically significant change in diastolic BP
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With Vital Signs Findings
Clinically significant change in temperature
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: up to 30 daysPopulation: Twelve-lead ECG assessments were made predose on Day -1 and at regular timepoints until Follow-up (Day 30). ECG=electrocardiogram; OD=once daily; BID=twice daily; PR=PR interval.
The following variables were recorded in 12-lead ECGs: ventricular rate, PR interval, QRS interval, QTcB and QTcF interval.
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
n=6 Participants
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With 12-lead Electrocardiogram Findings
Clinically significant changes in ventricular rate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With 12-lead Electrocardiogram Findings
Clinically significant changes in PR interval
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With 12-lead Electrocardiogram Findings
Clinically significant changes in QRS interval
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With 12-lead Electrocardiogram Findings
Clinically significant changes in QTcB interval
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: up to 120 daysPopulation: Clinical laboratory parameters were measured pre-dose on Day -1, at regular time points until Follow-up (Day 30), and at each long-term follow-up visit. OD=once daily; BID=twice daily.
Clinical laboratory parameters included clinical chemistry, hematology, coagulation and urinalysis.
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
n=6 Participants
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With Clinical Laboratory Tests Findings
Clinically significant clinical chemistry changes
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With Clinical Laboratory Tests Findings
Clinically significant hematology changes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With Clinical Laboratory Tests Findings
Clinically significant coagulation changes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With Clinical Laboratory Tests Findings
Clinically significant urinalysis changes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: up to 10 daysPopulation: Ophthalmological assessments were performed at the second screening visit after all other eligibility criteria had been met and on Day 10. OD=once daily; BID=twice daily.
Ophthalmological examinations at Screening Visit 2 and Day 10 were done at a specialist eye hospital by a Consultant Ophthalmologist, or their assistant. Examinations included: ocular symptoms and history, autorefraction, best correct visual acuity, colour vision, Amsler grid, ocular alignment and motility, confrontation visual field, slit-lamp, measurement of intraocular pressure and an optical coherence tomography test.
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
n=6 Participants
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With Ophthalmology Assessment Findings
Clinically significant ocular symptoms
|
3 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With Ophthalmology Assessment Findings
Clinically significant Amsler grid assessment
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: up to 120 daysPopulation: Physical and neurological examinations were measured pre-dose on Day -1, at regular time points until Follow-up (Day 30), and at each long-term follow-up visit. Results are reported for subjects experiencing abnormal result/AE, as opposed to individual events. OD=once daily; BID=twice daily.
Abnormal or clinically significant physical examination findings during the study or reported as an adverse event.
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
n=6 Participants
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With Physical Examination Findings
Abnormal physical examination
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With Physical Examination Findings
Physical examination reported as an AE
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: up to 120 daysPopulation: Neurological examinations were measured pre-dose on Day -1, at regular time points until Follow-up (Day 30), and at each long-term follow-up visit. OD=once daily; BID=twice daily.
Abnormal or clinically significant neurological examination findings during the study or reported as an adverse event.
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
n=6 Participants
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With Neurological Examination Findings
Abnormal neurological examination
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With Neurological Examination Findings
Neurological examination reported as an AE
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Day 1, pre-dose to Day 9, 24 hours post-dosePopulation: OD=once daily; BID=twice daily.
Summary of geometric mean emodepside plasma pharmacokinetic concentration-time data (ng/mL) during the repeated dosing period (Days 0-9) in healthy men. Subjects in the 10 mg emodepside BID dosing group had twice-daily doses on Days 0-8 and a single dose on the morning of Day 9. Therefore, the Day 9, 24 h post-dose value was not comparable to the previous value in that dosing group.
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Geometric Mean Emodepside Plasma Pharmacokinetic Concentration-Time Data During the Repeated Dosing Period
Day 1, pre-dose
|
8.77 ng/mL
Geometric Coefficient of Variation 35.8
|
15.78 ng/mL
Geometric Coefficient of Variation 42.9
|
45.94 ng/mL
Geometric Coefficient of Variation 35.1
|
—
|
|
Geometric Mean Emodepside Plasma Pharmacokinetic Concentration-Time Data During the Repeated Dosing Period
Day 2, pre-dose
|
15.24 ng/mL
Geometric Coefficient of Variation 31.1
|
28.80 ng/mL
Geometric Coefficient of Variation 40.0
|
64.62 ng/mL
Geometric Coefficient of Variation 38.5
|
—
|
|
Geometric Mean Emodepside Plasma Pharmacokinetic Concentration-Time Data During the Repeated Dosing Period
Day 3, pre-dose
|
21.22 ng/mL
Geometric Coefficient of Variation 35.0
|
39.08 ng/mL
Geometric Coefficient of Variation 45.6
|
84.65 ng/mL
Geometric Coefficient of Variation 37.7
|
—
|
|
Geometric Mean Emodepside Plasma Pharmacokinetic Concentration-Time Data During the Repeated Dosing Period
Day 4, pre-dose
|
24.81 ng/mL
Geometric Coefficient of Variation 37.4
|
47.38 ng/mL
Geometric Coefficient of Variation 42.2
|
98.01 ng/mL
Geometric Coefficient of Variation 32.0
|
—
|
|
Geometric Mean Emodepside Plasma Pharmacokinetic Concentration-Time Data During the Repeated Dosing Period
Day 5, pre-dose
|
31.46 ng/mL
Geometric Coefficient of Variation 36.3
|
60.07 ng/mL
Geometric Coefficient of Variation 42.9
|
120.98 ng/mL
Geometric Coefficient of Variation 31.1
|
—
|
|
Geometric Mean Emodepside Plasma Pharmacokinetic Concentration-Time Data During the Repeated Dosing Period
Day 6, pre-dose
|
36.68 ng/mL
Geometric Coefficient of Variation 36.7
|
70.88 ng/mL
Geometric Coefficient of Variation 39.6
|
137.60 ng/mL
Geometric Coefficient of Variation 35.2
|
—
|
|
Geometric Mean Emodepside Plasma Pharmacokinetic Concentration-Time Data During the Repeated Dosing Period
Day 7, pre-dose
|
40.57 ng/mL
Geometric Coefficient of Variation 31.4
|
83.31 ng/mL
Geometric Coefficient of Variation 43.0
|
149.41 ng/mL
Geometric Coefficient of Variation 33.3
|
—
|
|
Geometric Mean Emodepside Plasma Pharmacokinetic Concentration-Time Data During the Repeated Dosing Period
Day 8, pre-dose
|
46.91 ng/mL
Geometric Coefficient of Variation 36.8
|
91.63 ng/mL
Geometric Coefficient of Variation 42.4
|
179.90 ng/mL
Geometric Coefficient of Variation 35.3
|
—
|
|
Geometric Mean Emodepside Plasma Pharmacokinetic Concentration-Time Data During the Repeated Dosing Period
Day 9, pre-dose
|
49.73 ng/mL
Geometric Coefficient of Variation 35.1
|
97.11 ng/mL
Geometric Coefficient of Variation 44.0
|
184.94 ng/mL
Geometric Coefficient of Variation 37.1
|
—
|
|
Geometric Mean Emodepside Plasma Pharmacokinetic Concentration-Time Data During the Repeated Dosing Period
Day 9, 24 hour post-dose
|
51.76 ng/mL
Geometric Coefficient of Variation 36.6
|
108.17 ng/mL
Geometric Coefficient of Variation 49.1
|
176.10 ng/mL
Geometric Coefficient of Variation 39.8
|
—
|
SECONDARY outcome
Timeframe: AUClast in plasma after the last dose (Day 9)Population: OD=once daily; BID=twice daily.
Summary of AUClast of emodepside after the last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120h (Day 14) after the morning dose. AUClast: the area under the concentration-time curve from time zero (pre-dose) to the time of last quantifiable concentration. PK=pharmacokinetic. The geometric coefficient of variation is the between-subject coefficient of variation (%CVb).
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
The AUClast of Emodepside in Plasma
|
19359 h*ng/mL
Geometric Coefficient of Variation 29.9
|
40655 h*ng/mL
Geometric Coefficient of Variation 43.5
|
59554 h*ng/mL
Geometric Coefficient of Variation 29.1
|
—
|
SECONDARY outcome
Timeframe: AUClast /D in plasma after the last dose (Day 9)Population: OD=once daily; BID=twice daily.
Summary of AUClast/D of emodepside after the last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120h (Day 14) after the morning dose. AUClast/D: the area under the concentration-time curve from time zero (pre-dose) to the time of last quantifiable concentration corrected for dose. The geometric coefficient of variation is the between-subject coefficient of variation (%CVb).
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
The AUClast/D of Emodepside in Plasma
|
3872 h*ng/mL/mg
Geometric Coefficient of Variation 29.9
|
4065 h*ng/mL/mg
Geometric Coefficient of Variation 43.5
|
5955 h*ng/mL/mg
Geometric Coefficient of Variation 29.1
|
—
|
SECONDARY outcome
Timeframe: AUClast,norm in plasma after the last (Day 9) dosePopulation: OD=once daily; BID=twice daily.
Summary of AUClast,norm of emodepside after the last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120h (Day 14) after the morning dose. AUClast,norm: the area under the concentration-time curve from time zero (pre-dose) to the time of last quantifiable concentration corrected by dose and body weight. The geometric coefficient of variation is the between-subject coefficient of variation (%CVb).
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
The AUClast,Norm of Emodepside in Plasma
|
53.9 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 33.1
|
52.9 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 69.5
|
79.1 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 40.6
|
—
|
SECONDARY outcome
Timeframe: AUC12 in plasma after the first (Day 0) and last (Day 9) dosePopulation: BID=twice daily.
Summary of AUC12 of emodepside after the first (Day 0) and last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population. Data on Day 0 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 15h after the morning dose. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120h (Day 14) after the morning dose. AUC12: the area under the concentration-time curve from time zero (pre-dose) to 12h. Note: AUC12 was calculated only in Cohort 3. The geometric coefficient of variation is the between-subject coefficient of variation (%CVb).
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
The AUC12 of Emodepside in Plasma
Day 0
|
742 h*ng/mL
Geometric Coefficient of Variation 29.4
|
—
|
—
|
—
|
|
The AUC12 of Emodepside in Plasma
Day 9
|
2810 h*ng/mL
Geometric Coefficient of Variation 35.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: AUC12/D in plasma after the first (Day 0) and last (Day 9) dosePopulation: BID=twice daily.
Summary of AUC12/D of emodepside after the first (Day 0) and last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population. Data on Day 0 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 15h after the morning dose. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120h (Day 14) after the morning dose. AUC12/D: the area under the concentration-time curve from time zero (pre-dose) to 12h, corrected for dose. Note: AUC12/D was collected only in Cohort 3. The geometric coefficient of variation is the between-subject coefficient of variation (%CVb).
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
The AUC12/D of Emodepside in Plasma
Day 0
|
74.2 h*ng/mL/mg
Geometric Coefficient of Variation 29.4
|
—
|
—
|
—
|
|
The AUC12/D of Emodepside in Plasma
Day 9
|
281 h*ng/mL/mg
Geometric Coefficient of Variation 35.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: AUC12,norm in plasma after the first (Day 0) and last (Day 9) dosePopulation: BID=twice daily.
Summary of AUC12,norm of emodepside after the first (Day 0) and last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population. Data on Day 0 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 15 h after the morning dose. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120 h (Day 14) after the morning dose. AUC12,norm: the area under the concentration-time curve from time zero (pre-dose) to 12 h corrected by dose and body weight. Note: AUC12,norm was calculated only in Cohort 3. The geometric coefficient of variation is the between-subject coefficient of variation (%CVb).
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
The AUC12,Norm of Emodepside in Plasma
Day 0
|
0.985 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 39.2
|
—
|
—
|
—
|
|
The AUC12,Norm of Emodepside in Plasma
Day 9
|
3.73 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 46.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: AUC24 in plasma after the first (Day 0) and last (Day 9) dosePopulation: OD=once daily; BID=twice daily.
Summary of AUC24 of emodepside after the first (Day 0) and last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population. Data on Day 0 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 15 h after the morning dose. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120 h (Day 14) after the morning dose. AUC24: the area under the concentration-time curve from time zero (pre-dose) to 24 h. The geometric coefficient of variation is the between-subject coefficient of variation (%CVb).
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
The AUC24 of Emodepside in Plasma
Day 0
|
574 h*ng/mL
Geometric Coefficient of Variation 19.7
|
1135 h*ng/mL
Geometric Coefficient of Variation 32.7
|
1428 h*ng/mL
Geometric Coefficient of Variation 26.5
|
—
|
|
The AUC24 of Emodepside in Plasma
Day 9
|
1689 h*ng/mL
Geometric Coefficient of Variation 31.3
|
3487 h*ng/mL
Geometric Coefficient of Variation 44.2
|
4897 h*ng/mL
Geometric Coefficient of Variation 35.8
|
—
|
SECONDARY outcome
Timeframe: AUC24/D in plasma after the first (Day 0) and last (Day 9) dosePopulation: OD=once daily; BID=twice daily.
Summary of AUC24/D of emodepside after the first (Day 0) and last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population. Data on Day 0 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 15 h after the morning dose. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120 h (Day 14) after the morning dose. AUC24/D: the area under the concentration-time curve from time zero (pre-dose) to 24h corrected for dose. The geometric coefficient of variation is the between-subject coefficient of variation (%CVb).
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
The AUC24/D of Emodepside in Plasma
Day 0
|
115 h*ng/mL/mg
Geometric Coefficient of Variation 19.7
|
113 h*ng/mL/mg
Geometric Coefficient of Variation 32.7
|
71.4 h*ng/mL/mg
Geometric Coefficient of Variation 26.5
|
—
|
|
The AUC24/D of Emodepside in Plasma
Day 9
|
338 h*ng/mL/mg
Geometric Coefficient of Variation 31.3
|
349 h*ng/mL/mg
Geometric Coefficient of Variation 44.2
|
490 h*ng/mL/mg
Geometric Coefficient of Variation 35.8
|
—
|
SECONDARY outcome
Timeframe: AUC24,norm in plasma at Day 0 and Day 9Population: OD=once daily; BID=twice daily.
Summary of AUC24,norm of emodepside after the first (Day 0) and last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population. Data on Day 0 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 15h after the morning dose. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120h (Day 14) after the morning dose. AUC24,norm: the area under the concentration-time curve from time zero (pre-dose) to 24h corrected by dose and body weight. The geometric coefficient of variation is the between-subject coefficient of variation (%CVb).
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
The AUC24,Norm of Emodepside in Plasma
Day 0
|
1.60 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 21.5
|
1.48 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 56.7
|
0.948 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 36.5
|
—
|
|
The AUC24,Norm of Emodepside in Plasma
Day 9
|
4.70 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 34.1
|
4.54 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 69.7
|
6.50 (h*ng/mL)/(mg*kg)
Geometric Coefficient of Variation 47.7
|
—
|
SECONDARY outcome
Timeframe: Cmax in plasma after the first (Day 0) and last (Day 9) dosePopulation: OD=once daily; BID=twice daily.
Summary of Cmax of emodepside after the first (Day 0) and last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population. Data on Day 0 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 15 h after the morning dose. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120 h (Day 14) after the morning dose. Cmax: the observed maximum plasma concentration measured in a subject after dosing identified by inspection of the drug concentration vs. time data. The geometric coefficient of variation is the between-subject coefficient of variation (%CVb).
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
The Cmax of Emodepside in Plasma
Day 0
|
93.8 ng/mL
Geometric Coefficient of Variation 17.8
|
186 ng/mL
Geometric Coefficient of Variation 21.3
|
160 ng/mL
Geometric Coefficient of Variation 20.4
|
—
|
|
The Cmax of Emodepside in Plasma
Day 9
|
149 ng/mL
Geometric Coefficient of Variation 17.9
|
287 ng/mL
Geometric Coefficient of Variation 39.7
|
349 ng/mL
Geometric Coefficient of Variation 27.1
|
—
|
SECONDARY outcome
Timeframe: Cmax/D in plasma after the first (Day 0) and last (Day 9) dosePopulation: OD=once daily; BID=twice daily.
Summary of Cmax/D of emodepside after the first (Day 0) and last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population. Data on Day 0 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 15 h after the morning dose. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120 h (Day 14) after the morning dose. Cmax/D: the observed maximum plasma concentration measured in a subject after dosing identified by inspection of the drug concentration vs. time data, corrected for dose. The geometric coefficient of variation is the between-subject coefficient of variation (%CVb).
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
The Cmax/D of Emodepside in Plasma
Day 0
|
18.8 ng/mL/mg
Geometric Coefficient of Variation 17.8
|
18.6 ng/mL/mg
Geometric Coefficient of Variation 21.3
|
16.0 ng/mL/mg
Geometric Coefficient of Variation 20.4
|
—
|
|
The Cmax/D of Emodepside in Plasma
Day 9
|
29.9 ng/mL/mg
Geometric Coefficient of Variation 17.9
|
28.7 ng/mL/mg
Geometric Coefficient of Variation 39.7
|
34.9 ng/mL/mg
Geometric Coefficient of Variation 27.1
|
—
|
SECONDARY outcome
Timeframe: Cmax,norm in plasma after the first (Day 0) and last (Day 9) dosePopulation: OD=once daily; BID=twice daily.
Summary of Cmax,norm of emodepside after the first (Day 0) and last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population. Data on Day 0 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 15 h after the morning dose. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120 h (Day 14) after the morning dose. Cmax,norm: the observed maximum plasma concentration measured in a subject after dosing identified by inspection of the drug concentration vs. time data, corrected for dose and body weight. The geometric coefficient of variation is the between-subject coefficient of variation (%CVb).
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
The Cmax,Norm of Emodepside in Plasma
Day 0
|
0.261 (ng/mL)*(mg*kg)
Geometric Coefficient of Variation 18.4
|
0.242 (ng/mL)*(mg*kg)
Geometric Coefficient of Variation 42.8
|
0.212 (ng/mL)*(mg*kg)
Geometric Coefficient of Variation 28.7
|
—
|
|
The Cmax,Norm of Emodepside in Plasma
Day 9
|
0.416 (ng/mL)*(mg*kg)
Geometric Coefficient of Variation 20.6
|
0.374 (ng/mL)*(mg*kg)
Geometric Coefficient of Variation 65.4
|
0.464 (ng/mL)*(mg*kg)
Geometric Coefficient of Variation 38.2
|
—
|
SECONDARY outcome
Timeframe: Ctrough in plasma after the last (Day 9) dosePopulation: OD=once daily; BID=twice daily.
Summary of Ctrough (log-transformed) of emodepside after last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120 h (Day 14) after the morning dose. Ctrough: trough plasma concentration (measured concentration at the end of a dosing interval on Day 9 \[taken directly before next administration\]) obtained directly from the concentration-time data. The geometric coefficient of variation is the between-subject coefficient of variation (%CVb).
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
The Ctrough of Emodepside in Plasma
|
49.7 ng/mL
Geometric Coefficient of Variation 36.8
|
97.1 ng/mL
Geometric Coefficient of Variation 50.8
|
185 ng/mL
Geometric Coefficient of Variation 39.5
|
—
|
SECONDARY outcome
Timeframe: tmax in plasma after the first (Day 0) and last (Day 9) dosePopulation: OD=once daily; BID=twice daily.
Summary of tmax of emodepside after the first (Day 0) and last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population. Data on Day 0 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 15 h after the morning dose. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120 h (Day 14) after the morning dose. tmax: the time at which Cmax was apparent, identified by inspection of the drug concentration vs. time data.
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
The Tmax of Emodepside in Plasma
Day 0
|
1.00 Hours
Interval 1.0 to 1.07
|
1.25 Hours
Interval 1.0 to 2.0
|
1.00 Hours
Interval 1.0 to 1.58
|
—
|
|
The Tmax of Emodepside in Plasma
Day 9
|
1.00 Hours
Interval 1.0 to 1.5
|
1.25 Hours
Interval 1.0 to 2.0
|
1.50 Hours
Interval 1.03 to 2.5
|
—
|
SECONDARY outcome
Timeframe: t1/2 in plasma after the last (Day 9) dosePopulation: OD=once daily; BID=twice daily.
Summary of t1/2 of emodepside after the last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120 h (Day 14) after the morning dose. t1/2: terminal half-life. The geometric coefficient of variation is the between-subject coefficient of variation (%CVb).
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
The t1/2 of Emodepside in Plasma
|
419 Hours
Geometric Coefficient of Variation 42.6
|
450 Hours
Geometric Coefficient of Variation 30.6
|
508 Hours
Geometric Coefficient of Variation 56.9
|
—
|
SECONDARY outcome
Timeframe: t1/2,(0-24) in plasma after the last (Day 9) dosePopulation: OD=once daily; BID=twice daily.
Summary of t1/2,(0-24) of emodepside after the last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120 h (Day 14) after the morning dose. t1/2,(0-24): half-life calculated from the terminal slope of the log concentration-time (0-24h) curve. The geometric coefficient of variation is the between-subject coefficient of variation (%CVb).
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
The t1/2,(0-24) of Emodepside in Plasma
|
26.9 Hours
Geometric Coefficient of Variation 52.4
|
18.4 Hours
Geometric Coefficient of Variation 30.0
|
33.2 Hours
Geometric Coefficient of Variation 55.0
|
—
|
SECONDARY outcome
Timeframe: λz in plasma after the last (Day 9) dosePopulation: OD=once daily; BID=twice daily.
Summary of λz of emodepside after the last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120 h (Day 14) after the morning dose. λz: terminal rate constant. The geometric coefficient of variation is the between-subject coefficient of variation (%CVb).
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
The λz of Emodepside in Plasma
|
0.00166 1/h
Geometric Coefficient of Variation 42.6
|
0.00154 1/h
Geometric Coefficient of Variation 30.6
|
0.00137 1/h
Geometric Coefficient of Variation 56.9
|
—
|
SECONDARY outcome
Timeframe: CLss/F in plasma after the last (Day 9) dosePopulation: OD=once daily; BID=twice daily.
Summary of CLss/F of emodepside after the last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120 h (Day 14) after the morning dose. CLss/F: apparent total clearance from plasma on Day 9. The geometric coefficient of variation is the between-subject coefficient of variation (%CVb).
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
The CLss/F of Emodepside in Plasma
|
2.96 L/h
Geometric Coefficient of Variation 31.3
|
2.87 L/h
Geometric Coefficient of Variation 44.2
|
3.56 L/h
Geometric Coefficient of Variation 35.0
|
—
|
SECONDARY outcome
Timeframe: Vz/F in plasma after the last (Day 9) dosePopulation: OD=once daily; BID=twice daily.
Summary of Vz/F of emodepside after the last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120 h (Day 14) after the morning dose. Vz/F: apparent volume of distribution on Day 9. The geometric coefficient of variation is the between-subject coefficient of variation (%CVb).
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
The Vz/F of Emodepside in Plasma
|
1788 litre(s)
Geometric Coefficient of Variation 74.2
|
1861 litre(s)
Geometric Coefficient of Variation 68.5
|
2607 litre(s)
Geometric Coefficient of Variation 102.1
|
—
|
SECONDARY outcome
Timeframe: MRTlast in plasma after the first (Day 0) dosePopulation: OD=once daily; BID=twice daily.
Summary of MRTlast of emodepside after the first (Day 0) dose for 10-day oral treatment courses in healthy men: PK parameter population. Data on Day 0 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 15 h after the morning dose. MRTlast: mean residence time from time zero (pre-dose) to the time of last quantifiable concentration (measurable up to 24h after dosing on Day 0). The geometric coefficient of variation is the between-subject coefficient of variation (%CVb).
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
The MRTlast of Emodepside in Plasma
|
7.28 Hours
Geometric Coefficient of Variation 10.7
|
7.00 Hours
Geometric Coefficient of Variation 11.0
|
10.8 Hours
Geometric Coefficient of Variation 2.8
|
—
|
SECONDARY outcome
Timeframe: Rac(AUC12) after 10 days' repeated doses of 10 mg emodepside (Day 9)Population: BID=twice daily.
Summary of emodepside plasma Rac(AUC12) after 10 days' repeated doses of 10 mg emodepside (Day 9): PK parameter population. Rac(AUC12): accumulation ratio calculated from AUC12, where AUC12 is the area under the concentration-time curve from time zero (pre-dose) to 12h. Note: measure of dispersion is 'percentage coefficient of variation' (the between-subject coefficient of variation \[%CVb\]). Note: Rac(AUC12) was calculated only in Cohort 3.
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
The Rac(AUC12) of Emodepside in Plasma
|
3.83 Ratio
Standard Deviation 15.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Rac(AUC24) after 10 days' repeated doses of 10 mg emodepside (Day 9)Population: OD=once daily; BID=twice daily.
Summary of emodepside plasma Rac(AUC24) after 10 days' repeated doses of 10 mg emodepside (Day 9): PK parameter population. Rac(AUC24): accumulation ratio calculated from AUC24, where AUC24 is the area under the concentration-time curve from time zero (pre-dose) to 24h. Note: measure of dispersion is 'percentage coefficient of variation' (the between-subject coefficient of variation \[%CVb\]).
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
The Rac(AUC24) of Emodepside in Plasma
|
2.97 Ratio
Standard Deviation 16.1
|
3.09 Ratio
Standard Deviation 11.3
|
3.47 Ratio
Standard Deviation 17.1
|
—
|
SECONDARY outcome
Timeframe: Rac(Cmax) after 10 days' repeated doses of 10 mg emodepside (Day 9)Population: OD=once daily; BID=twice daily.
Summary of emodepside plasma Rac(Cmax) after 10 days' repeated doses of 10 mg emodepside (Day 9): PK parameter population. Rac(Cmax): accumulation ratio calculated from Cmax, where Cmax is the observed maximum plasma concentration measured in a subject after dosing identified by inspection of the drug concentration vs. time data. Note: measure of dispersion is 'percentage coefficient of variation' (the between-subject coefficient of variation \[%CVb\]).
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
The Rac(Cmax) of Emodepside in Plasma
|
1.61 Ratio
Standard Deviation 16.5
|
1.58 Ratio
Standard Deviation 24.1
|
2.21 Ratio
Standard Deviation 17.4
|
—
|
SECONDARY outcome
Timeframe: Mean glucose at Day -1 after repeated once or twice daily dosingPopulation: OD=once daily; BID=twice daily.
Mean glucose concentrations (mmol/L) after repeated once or twice daily dosing with up to 10 mg emodepside or placebo at Day -1.
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
n=6 Participants
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Mean Glucose Concentration at Day -1
-24 h
|
4.72 mmol/L
Standard Deviation 0.286
|
4.68 mmol/L
Standard Deviation 0.349
|
4.80 mmol/L
Standard Deviation 0.245
|
4.77 mmol/L
Standard Deviation 0.468
|
|
Mean Glucose Concentration at Day -1
-23 h
|
4.90 mmol/L
Standard Deviation 0.308
|
4.85 mmol/L
Standard Deviation 0.259
|
4.85 mmol/L
Standard Deviation 0.281
|
4.92 mmol/L
Standard Deviation 0.313
|
|
Mean Glucose Concentration at Day -1
-22 h
|
4.77 mmol/L
Standard Deviation 0.378
|
4.72 mmol/L
Standard Deviation 0.371
|
4.72 mmol/L
Standard Deviation 0.279
|
4.82 mmol/L
Standard Deviation 0.360
|
|
Mean Glucose Concentration at Day -1
-20 h
|
4.63 mmol/L
Standard Deviation 0.388
|
4.57 mmol/L
Standard Deviation 0.207
|
4.55 mmol/L
Standard Deviation 0.207
|
4.73 mmol/L
Standard Deviation 0.480
|
|
Mean Glucose Concentration at Day -1
-12 h
|
5.17 mmol/L
Standard Deviation 0.712
|
5.55 mmol/L
Standard Deviation 0.451
|
5.52 mmol/L
Standard Deviation 0.556
|
5.48 mmol/L
Standard Deviation 0.806
|
SECONDARY outcome
Timeframe: Mean glucose after repeated once or twice daily dosing for up to 10 daysPopulation: OD=once daily; BID=twice daily.
Mean glucose concentrations (mmol/L) after repeated once or twice daily dosing with up to 10 mg emodepside or placebo at Day 0. Baseline=predose on Day 0.
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
n=6 Participants
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Mean Glucose Concentration at Day 0
Predose (Baseline)
|
4.96 mmol/L
Standard Deviation 0.321
|
4.85 mmol/L
Standard Deviation 0.409
|
4.85 mmol/L
Standard Deviation 0.351
|
4.85 mmol/L
Standard Deviation 0.288
|
|
Mean Glucose Concentration at Day 0
1 h
|
5.07 mmol/L
Standard Deviation 0.367
|
5.57 mmol/L
Standard Deviation 0.816
|
5.42 mmol/L
Standard Deviation 0.445
|
4.78 mmol/L
Standard Deviation 0.214
|
|
Mean Glucose Concentration at Day 0
2 h
|
5.05 mmol/L
Standard Deviation 0.327
|
5.28 mmol/L
Standard Deviation 0.508
|
5.27 mmol/L
Standard Deviation 0.472
|
4.70 mmol/L
Standard Deviation 0.310
|
|
Mean Glucose Concentration at Day 0
4 h
|
4.73 mmol/L
Standard Deviation 0.378
|
4.75 mmol/L
Standard Deviation 0.274
|
4.82 mmol/L
Standard Deviation 0.279
|
4.70 mmol/L
Standard Deviation 0.276
|
|
Mean Glucose Concentration at Day 0
12 h
|
5.68 mmol/L
Standard Deviation 0.268
|
6.22 mmol/L
Standard Deviation 0.343
|
5.57 mmol/L
Standard Deviation 0.554
|
6.27 mmol/L
Standard Deviation 0.761
|
|
Mean Glucose Concentration at Day 0
24 h
|
5.07 mmol/L
Standard Deviation 0.314
|
4.88 mmol/L
Standard Deviation 0.264
|
4.87 mmol/L
Standard Deviation 0.273
|
4.97 mmol/L
Standard Deviation 0.288
|
SECONDARY outcome
Timeframe: Mean glucose at Day 9 after repeated once or twice daily dosingPopulation: OD=once daily; BID=twice daily.
Mean glucose concentrations (mmol/L) after repeated once or twice daily dosing with up to 10 mg emodepside or placebo at Day 9.
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
n=6 Participants
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Mean Glucose Concentration at Day 9
Predose
|
4.52 mmol/L
Standard Deviation 0.306
|
4.95 mmol/L
Standard Deviation 0.362
|
4.97 mmol/L
Standard Deviation 0.314
|
4.67 mmol/L
Standard Deviation 0.234
|
|
Mean Glucose Concentration at Day 9
1 h
|
5.10 mmol/L
Standard Deviation 0.352
|
5.98 mmol/L
Standard Deviation 1.972
|
5.65 mmol/L
Standard Deviation 0.771
|
4.80 mmol/L
Standard Deviation 0.219
|
|
Mean Glucose Concentration at Day 9
2 h
|
5.03 mmol/L
Standard Deviation 0.250
|
5.72 mmol/L
Standard Deviation 1.543
|
5.57 mmol/L
Standard Deviation 0.761
|
4.74 mmol/L
Standard Deviation 0.329
|
|
Mean Glucose Concentration at Day 9
4 h
|
4.60 mmol/L
Standard Deviation 0.363
|
4.62 mmol/L
Standard Deviation 0.377
|
5.08 mmol/L
Standard Deviation 0.662
|
4.70 mmol/L
Standard Deviation 0.374
|
|
Mean Glucose Concentration at Day 9
12 h
|
5.58 mmol/L
Standard Deviation 0.319
|
6.00 mmol/L
Standard Deviation 0.745
|
7.03 mmol/L
Standard Deviation 1.111
|
6.02 mmol/L
Standard Deviation 0.615
|
|
Mean Glucose Concentration at Day 9
24 h
|
4.92 mmol/L
Standard Deviation 0.264
|
5.10 mmol/L
Standard Deviation 0.490
|
5.17 mmol/L
Standard Deviation 0.273
|
4.82 mmol/L
Standard Deviation 0.160
|
|
Mean Glucose Concentration at Day 9
48 h
|
5.02 mmol/L
Standard Deviation 0.194
|
5.07 mmol/L
Standard Deviation 0.532
|
5.10 mmol/L
Standard Deviation 0.390
|
4.90 mmol/L
Standard Deviation 0.379
|
|
Mean Glucose Concentration at Day 9
72 h
|
4.87 mmol/L
Standard Deviation 0.350
|
5.13 mmol/L
Standard Deviation 0.589
|
5.03 mmol/L
Standard Deviation 0.308
|
5.03 mmol/L
Standard Deviation 0.280
|
|
Mean Glucose Concentration at Day 9
96 h
|
4.80 mmol/L
Standard Deviation 0.276
|
5.10 mmol/L
Standard Deviation 0.540
|
4.85 mmol/L
Standard Deviation 0.315
|
4.87 mmol/L
Standard Deviation 0.320
|
|
Mean Glucose Concentration at Day 9
120 h
|
5.00 mmol/L
Standard Deviation 0.352
|
4.98 mmol/L
Standard Deviation 0.458
|
5.05 mmol/L
Standard Deviation 0.288
|
4.90 mmol/L
Standard Deviation 0.352
|
SECONDARY outcome
Timeframe: Mean glucose at Day 30 after repeated once or twice daily dosingPopulation: OD=once daily; BID=twice daily.
Mean glucose concentrations (mmol/L) after repeated once or twice daily dosing with up to 10 mg emodepside or placebo at Day 30.
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
n=6 Participants
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Mean Glucose Concentration at Day 30
|
4.83 mmol/L
Standard Deviation 0.288
|
5.23 mmol/L
Standard Deviation 0.993
|
4.97 mmol/L
Standard Deviation 0.234
|
4.53 mmol/L
Standard Deviation 0.350
|
SECONDARY outcome
Timeframe: Mean insulin concentration at Day-1 after repeated once or twice daily dosingPopulation: OD=once daily; BID=twice daily.
Mean insulin concentration (pmol/L) after repeated once or twice daily dosing with up to 10 mg emodepside or placebo at Day -1.
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
n=6 Participants
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Mean Insulin Concentration at Day -1
-24 h
|
29.0 pmol/L
Standard Deviation 8.60
|
25.8 pmol/L
Standard Deviation 8.11
|
33.2 pmol/L
Standard Deviation 17.90
|
32.3 pmol/L
Standard Deviation 12.31
|
|
Mean Insulin Concentration at Day -1
-23 h
|
25.8 pmol/L
Standard Deviation 3.87
|
26.2 pmol/L
Standard Deviation 7.73
|
28.0 pmol/L
Standard Deviation 11.33
|
26.5 pmol/L
Standard Deviation 8.92
|
|
Mean Insulin Concentration at Day -1
-22 h
|
24.0 pmol/L
Standard Deviation 6.69
|
25.7 pmol/L
Standard Deviation 8.91
|
28.3 pmol/L
Standard Deviation 14.50
|
33.0 pmol/L
Standard Deviation 5.73
|
|
Mean Insulin Concentration at Day -1
-20 h
|
22.7 pmol/L
Standard Deviation 6.02
|
22.7 pmol/L
Standard Deviation 7.97
|
24.3 pmol/L
Standard Deviation 9.18
|
24.5 pmol/L
Standard Deviation 12.76
|
|
Mean Insulin Concentration at Day -1
-12 h
|
129.5 pmol/L
Standard Deviation 54.14
|
157.0 pmol/L
Standard Deviation 81.51
|
204.7 pmol/L
Standard Deviation 78.37
|
136.5 pmol/L
Standard Deviation 64.30
|
SECONDARY outcome
Timeframe: Mean insulin concentration at Day 0 after repeated once or twice daily dosingPopulation: OD=once daily; BID=twice daily.
Mean insulin concentration (pmol/L) after repeated once or twice daily dosing with up to 10 mg emodepside or placebo at Day 0. Baseline=predose on Day 0.
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
n=6 Participants
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Mean Insulin Concentration at Day 0
Predose (Baseline)
|
27.8 pmol/L
Standard Deviation 15.41
|
29.3 pmol/L
Standard Deviation 5.09
|
32.2 pmol/L
Standard Deviation 14.34
|
30.5 pmol/L
Standard Deviation 12.55
|
|
Mean Insulin Concentration at Day 0
1 h
|
25.0 pmol/L
Standard Deviation 3.79
|
23.2 pmol/L
Standard Deviation 10.85
|
29.2 pmol/L
Standard Deviation 14.86
|
33.0 pmol/L
Standard Deviation 9.10
|
|
Mean Insulin Concentration at Day 0
2 h
|
24.3 pmol/L
Standard Deviation 5.20
|
25.3 pmol/L
Standard Deviation 9.99
|
36.3 pmol/L
Standard Deviation 20.39
|
31.2 pmol/L
Standard Deviation 12.89
|
|
Mean Insulin Concentration at Day 0
4 h
|
21.7 pmol/L
Standard Deviation 5.01
|
21.7 pmol/L
Standard Deviation 5.39
|
27.7 pmol/L
Standard Deviation 11.69
|
20.2 pmol/L
Standard Deviation 6.85
|
|
Mean Insulin Concentration at Day 0
12 h
|
127.2 pmol/L
Standard Deviation 67.59
|
203.2 pmol/L
Standard Deviation 83.22
|
175.3 pmol/L
Standard Deviation 64.59
|
195.0 pmol/L
Standard Deviation 88.03
|
|
Mean Insulin Concentration at Day 0
24 h
|
36.7 pmol/L
Standard Deviation 15.49
|
41.2 pmol/L
Standard Deviation 14.51
|
30.3 pmol/L
Standard Deviation 11.43
|
35.2 pmol/L
Standard Deviation 16.59
|
SECONDARY outcome
Timeframe: Mean insulin concentration at Day 9 after repeated once or twice daily dosingPopulation: OD=once daily; BID=twice daily.
Mean insulin concentration (pmol/L) after repeated once or twice daily dosing with up to 10 mg emodepside or placebo at Day 9.
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
n=6 Participants
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Mean Insulin Concentration at Day 9
Predose
|
31.5 pmol/L
Standard Deviation 8.62
|
32.7 pmol/L
Standard Deviation 15.02
|
29.2 pmol/L
Standard Deviation 10.19
|
31.3 pmol/L
Standard Deviation 9.83
|
|
Mean Insulin Concentration at Day 9
1 h
|
29.2 pmol/L
Standard Deviation 9.66
|
24.4 pmol/L
Standard Deviation 15.39
|
22.2 pmol/L
Standard Deviation 8.89
|
27.8 pmol/L
Standard Deviation 9.77
|
|
Mean Insulin Concentration at Day 9
2 h
|
27.7 pmol/L
Standard Deviation 4.84
|
31.2 pmol/L
Standard Deviation 10.53
|
30.2 pmol/L
Standard Deviation 13.91
|
29.8 pmol/L
Standard Deviation 10.26
|
|
Mean Insulin Concentration at Day 9
4 h
|
23.0 pmol/L
Standard Deviation 7.35
|
28.4 pmol/L
Standard Deviation 13.24
|
19.5 pmol/L
Standard Deviation 9.12
|
21.8 pmol/L
Standard Deviation 6.37
|
|
Mean Insulin Concentration at Day 9
12 h
|
147.2 pmol/L
Standard Deviation 77.58
|
143.0 pmol/L
Standard Deviation 113.7
|
215.8 pmol/L
Standard Deviation 128.1
|
215.7 pmol/L
Standard Deviation 151.8
|
|
Mean Insulin Concentration at Day 9
24 h
|
34.5 pmol/L
Standard Deviation 11.88
|
36.5 pmol/L
Standard Deviation 12.24
|
32.7 pmol/L
Standard Deviation 17.44
|
36.3 pmol/L
Standard Deviation 13.03
|
|
Mean Insulin Concentration at Day 9
48 h
|
36.2 pmol/L
Standard Deviation 5.60
|
44.8 pmol/L
Standard Deviation 17.89
|
36.3 pmol/L
Standard Deviation 13.59
|
38.2 pmol/L
Standard Deviation 19.17
|
|
Mean Insulin Concentration at Day 9
72 h
|
48.3 pmol/L
Standard Deviation 23.53
|
40.7 pmol/L
Standard Deviation 13.88
|
39.8 pmol/L
Standard Deviation 15.61
|
38.7 pmol/L
Standard Deviation 14.42
|
|
Mean Insulin Concentration at Day 9
96 h
|
37.8 pmol/L
Standard Deviation 10.42
|
39.3 pmol/L
Standard Deviation 12.31
|
37.2 pmol/L
Standard Deviation 17.66
|
30.0 pmol/L
Standard Deviation 11.63
|
|
Mean Insulin Concentration at Day 9
120 h
|
39.0 pmol/L
Standard Deviation 8.63
|
42.3 pmol/L
Standard Deviation 17.92
|
36.0 pmol/L
Standard Deviation 15.24
|
33.2 pmol/L
Standard Deviation 21.68
|
SECONDARY outcome
Timeframe: Mean insulin concentration at Day 30 after repeated once or twice daily dosingPopulation: OD=once daily; BID=twice daily.
Mean insulin concentration (pmol/L) after repeated once or twice daily dosing with up to 10 mg emodepside or placebo at Day 30.
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
n=6 Participants
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Mean Insulin Concentration at Day 30
|
29.2 pmol/L
Standard Deviation 12.50
|
60.3 pmol/L
Standard Deviation 90.19
|
24.3 pmol/L
Standard Deviation 9.79
|
29.2 pmol/L
Standard Deviation 20.21
|
SECONDARY outcome
Timeframe: Mean serum glucose concentration at Day -2, before and up to 4 hours after intake of a high-glucose solutionPopulation: OD=once daily; BID=twice daily.
Oral glucose tolerance test: mean serum glucose concentration at Day -2, before and up to 4 hours after intake of a high-glucose solution, in subjects receiving repeated doses of emodepside or placebo for 10 days (Days 0-9). Baseline=pre-glucose intake on each respective day.
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
n=6 Participants
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Mean Serum Glucose Concentration at Day -2
0 h (Baseline)
|
4.72 mmol/L
Standard Deviation 0.319
|
4.92 mmol/L
Standard Deviation 0.256
|
4.97 mmol/L
Standard Deviation 0.294
|
4.78 mmol/L
Standard Deviation 0.133
|
|
Mean Serum Glucose Concentration at Day -2
1 h
|
8.78 mmol/L
Standard Deviation 1.659
|
7.03 mmol/L
Standard Deviation 0.301
|
7.00 mmol/L
Standard Deviation 0.867
|
6.48 mmol/L
Standard Deviation 1.450
|
|
Mean Serum Glucose Concentration at Day -2
2 h
|
5.98 mmol/L
Standard Deviation 1.512
|
5.05 mmol/L
Standard Deviation 0.589
|
5.48 mmol/L
Standard Deviation 0.608
|
4.95 mmol/L
Standard Deviation 0.965
|
|
Mean Serum Glucose Concentration at Day -2
4 h
|
4.57 mmol/L
Standard Deviation 0.979
|
3.95 mmol/L
Standard Deviation 0.622
|
4.22 mmol/L
Standard Deviation 0.371
|
4.53 mmol/L
Standard Deviation 0.294
|
SECONDARY outcome
Timeframe: Mean serum glucose concentration at Day 1, before and up to 4 hours after intake of a high-glucose solutionPopulation: OD=once daily; BID=twice daily.
Oral glucose tolerance test: mean serum glucose concentration at Day 1, before and up to 4 hours after intake of a high-glucose solution, in subjects receiving repeated doses of emodepside or placebo for 10 days (Days 0-9). Baseline=pre-glucose intake on each respective day.
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
n=6 Participants
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Mean Serum Glucose Concentration at Day 1
Predose (Baseline)
|
5.07 mmol/L
Standard Deviation 0.314
|
4.88 mmol/L
Standard Deviation 0.264
|
4.87 mmol/L
Standard Deviation 0.273
|
4.97 mmol/L
Standard Deviation 0.228
|
|
Mean Serum Glucose Concentration at Day 1
1 h
|
10.10 mmol/L
Standard Deviation 1.170
|
12.37 mmol/L
Standard Deviation 2.826
|
12.03 mmol/L
Standard Deviation 0.989
|
7.58 mmol/L
Standard Deviation 2.242
|
|
Mean Serum Glucose Concentration at Day 1
2 h
|
6.17 mmol/L
Standard Deviation 1.600
|
7.95 mmol/L
Standard Deviation 1.653
|
9.25 mmol/L
Standard Deviation 2.740
|
5.88 mmol/L
Standard Deviation 1.174
|
|
Mean Serum Glucose Concentration at Day 1
4 h
|
3.95 mmol/L
Standard Deviation 0.339
|
3.65 mmol/L
Standard Deviation 0.362
|
4.02 mmol/L
Standard Deviation 0.204
|
4.15 mmol/L
Standard Deviation 0.575
|
SECONDARY outcome
Timeframe: Mean serum glucose concentration at Day 8, before and up to 4 hours after intake of a high-glucose solutionPopulation: OD=once daily; BID=twice daily.
Oral glucose tolerance test: mean serum glucose concentration at Day 8, before and up to 4 hours after intake of a high-glucose solution, in subjects receiving repeated doses of emodepside or placebo for 10 days (Days 0-9). Baseline=pre-glucose intake on each respective day.
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
n=6 Participants
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Mean Serum Glucose Concentration at Day 8
Predose (Baseline)
|
4.87 mmol/L
Standard Deviation 0.314
|
5.10 mmol/L
Standard Deviation 0.533
|
4.90 mmol/L
Standard Deviation 0.303
|
4.83 mmol/L
Standard Deviation 0.258
|
|
Mean Serum Glucose Concentration at Day 8
1 h
|
10.02 mmol/L
Standard Deviation 1.857
|
11.75 mmol/L
Standard Deviation 4.574
|
11.27 mmol/L
Standard Deviation 2.738
|
7.77 mmol/L
Standard Deviation 1.679
|
|
Mean Serum Glucose Concentration at Day 8
2 h
|
7.05 mmol/L
Standard Deviation 1.533
|
8.98 mmol/L
Standard Deviation 4.311
|
8.97 mmol/L
Standard Deviation 2.837
|
5.52 mmol/L
Standard Deviation 0.783
|
|
Mean Serum Glucose Concentration at Day 8
4 h
|
3.93 mmol/L
Standard Deviation 0.965
|
4.12 mmol/L
Standard Deviation 0.933
|
4.52 mmol/L
Standard Deviation 0.806
|
4.13 mmol/L
Standard Deviation 0.197
|
SECONDARY outcome
Timeframe: Mean serum glucose concentration at Day 120, before and up to 4 hours after intake of a high-glucose solutionPopulation: OD=once daily; BID=twice daily.
Oral glucose tolerance test: mean serum glucose concentration at Day 120, before and up to 4 hours after intake of a high-glucose solution, in subjects receiving repeated doses of emodepside or placebo for 10 days (Days 0-9). Baseline=pre-glucose intake on each respective day. Note: At Day 120, serum glucose concentration was only measured in Cohort 3 (10 mg BID)
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Mean Serum Glucose Concentration at Day 120
0 h (Baseline)
|
4.93 mmol/L
Standard Deviation 0.294
|
—
|
—
|
—
|
|
Mean Serum Glucose Concentration at Day 120
1 h
|
8.12 mmol/L
Standard Deviation 2.542
|
—
|
—
|
—
|
|
Mean Serum Glucose Concentration at Day 120
2 h
|
6.08 mmol/L
Standard Deviation 0.540
|
—
|
—
|
—
|
|
Mean Serum Glucose Concentration at Day 120
4 h
|
4.26 mmol/L
Standard Deviation 0.305
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Mean serum insulin concentration at Day -2, before and up to 4 hours after intake of a high-glucose solutionPopulation: OD=once daily; BID=twice daily.
Oral glucose tolerance test: mean serum insulin concentration at Day -2, before and up to 4 hours after intake of a high-glucose solution, in subjects receiving repeated doses of emodepside or placebo for 10 days (Days 0-9). Baseline=pre-glucose intake on each respective day.
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
n=6 Participants
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Mean Serum Insulin Concentration at Day -2
0 h (Baseline)
|
24.5 pmol/L
Standard Deviation 13.81
|
25.7 pmol/L
Standard Deviation 8.55
|
27.0 pmol/L
Standard Deviation 14.00
|
29.0 pmol/L
Standard Deviation 14.68
|
|
Mean Serum Insulin Concentration at Day -2
1 h
|
334.8 pmol/L
Standard Deviation 207.66
|
305.3 pmol/L
Standard Deviation 65.59
|
306.7 pmol/L
Standard Deviation 180.00
|
338.3 pmol/L
Standard Deviation 189.61
|
|
Mean Serum Insulin Concentration at Day -2
2 h
|
174.7 pmol/L
Standard Deviation 206.08
|
103.7 pmol/L
Standard Deviation 32.38
|
136.0 pmol/L
Standard Deviation 70.52
|
186.8 pmol/L
Standard Deviation 83.55
|
|
Mean Serum Insulin Concentration at Day -2
4 h
|
44.3 pmol/L
Standard Deviation 72.56
|
17.2 pmol/L
Standard Deviation 6.11
|
20.8 pmol/L
Standard Deviation 7.44
|
21.8 pmol/L
Standard Deviation 9.33
|
SECONDARY outcome
Timeframe: Mean serum insulin concentration at Day 1, before and up to 4 hours after intake of a high-glucose solutionPopulation: OD=once daily; BID=twice daily.
Oral glucose tolerance test: mean serum insulin concentration at Day 1, before and up to 4 hours after intake of a high-glucose solution, in subjects receiving repeated doses of emodepside or placebo for 10 days (Days 0-9). Baseline=pre-glucose intake on each respective day.
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
n=6 Participants
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Mean Serum Insulin Concentration at Day 1
Predose (Baseline)
|
36.7 pmol/L
Standard Deviation 15.49
|
41.2 pmol/L
Standard Deviation 14.51
|
30.3 pmol/L
Standard Deviation 11.43
|
35.2 pmol/L
Standard Deviation 16.59
|
|
Mean Serum Insulin Concentration at Day 1
1 h
|
312.2 pmol/L
Standard Deviation 153.67
|
288.8 pmol/L
Standard Deviation 171.44
|
332.2 pmol/L
Standard Deviation 228.84
|
606.7 pmol/L
Standard Deviation 157.35
|
|
Mean Serum Insulin Concentration at Day 1
2 h
|
268.5 pmol/L
Standard Deviation 107.14
|
377.3 pmol/L
Standard Deviation 224.73
|
336.2 pmol/L
Standard Deviation 165.71
|
238.0 pmol/L
Standard Deviation 165.06
|
|
Mean Serum Insulin Concentration at Day 1
4 h
|
28.8 pmol/L
Standard Deviation 22.35
|
30.8 pmol/L
Standard Deviation 12.35
|
35.7 pmol/L
Standard Deviation 4.59
|
33.8 pmol/L
Standard Deviation 19.56
|
SECONDARY outcome
Timeframe: Mean serum insulin concentration at Day 8, before and up to 4 hours after intake of a high-glucose solutionPopulation: OD=once daily; BID=twice daily.
Oral glucose tolerance test: mean serum insulin concentration at Day 8, before and up to 4 hours after intake of a high-glucose solution, in subjects receiving repeated doses of emodepside or placebo for 10 days (Days 0-9). Baseline=pre-glucose intake on each respective day.
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
n=6 Participants
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Mean Serum Insulin Concentration at Day 8
Predose (Baseline)
|
32.5 pmol/L
Standard Deviation 9.85
|
39.3 pmol/L
Standard Deviation 22.59
|
34.5 pmol/L
Standard Deviation 15.83
|
33.8 pmol/L
Standard Deviation 12.94
|
|
Mean Serum Insulin Concentration at Day 8
1 h
|
302.5 pmol/L
Standard Deviation 145.61
|
286.8 pmol/L
Standard Deviation 179.53
|
225.3 pmol/L
Standard Deviation 148.93
|
690.5 pmol/L
Standard Deviation 342.10
|
|
Mean Serum Insulin Concentration at Day 8
2 h
|
337.0 pmol/L
Standard Deviation 110.23
|
225.7 pmol/L
Standard Deviation 101.02
|
229.8 pmol/L
Standard Deviation 79.00
|
238.3 pmol/L
Standard Deviation 92.34
|
|
Mean Serum Insulin Concentration at Day 8
4 h
|
63.0 pmol/L
Standard Deviation 86.69
|
63.3 pmol/L
Standard Deviation 83.32
|
36.8 pmol/L
Standard Deviation 21.17
|
21.7 pmol/L
Standard Deviation 19.97
|
SECONDARY outcome
Timeframe: Mean serum insulin concentration at Day 120, before and up to 4 hours after intake of a high-glucose solutionPopulation: OD=once daily; BID=twice daily.
Oral glucose tolerance test: mean serum insulin concentration at Day 120, before and up to 4 hours after intake of a high-glucose solution, in subjects receiving repeated doses of emodepside or placebo for 10 days (Days 0-9). Baseline=pre-glucose intake on each respective day. Note: At Day 120, serum glucose concentration was only measured in Cohort 3 (10 mg BID)
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Mean Serum Insulin Concentration at Day 120
0 h (Baseline)
|
28.0 pmol/L
Standard Deviation 13.74
|
—
|
—
|
—
|
|
Mean Serum Insulin Concentration at Day 120
1 h
|
417.8 pmol/L
Standard Deviation 379.72
|
—
|
—
|
—
|
|
Mean Serum Insulin Concentration at Day 120
2 h
|
152.8 pmol/L
Standard Deviation 114.92
|
—
|
—
|
—
|
|
Mean Serum Insulin Concentration at Day 120
4 h
|
18.8 pmol/L
Standard Deviation 11.39
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Drug-related AEs were reported throughout the studyPopulation: OD=once daily; BID=twice daily.
Subjects presenting drug-related treatment-emergent adverse events listed by preferred term. Note: subjects with ≥1 adverse event are counted only once per preferred term.
Outcome measures
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 Participants
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 Participants
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
n=6 Participants
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Drug-related Adverse Events
Visual impairment
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Drug-related Adverse Events
Euphoric mood
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Drug-related Adverse Events
Nervousness
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Drug-related Adverse Events
Dizziness
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1: 5mg EMODEPSIDE OD
Cohort 2: 10mg EMODEPSIDE OD
Cohort 3: 10mg EMODEPSIDE BID
Placebo Group
Serious adverse events
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 participants at risk
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 participants at risk
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 participants at risk
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
n=6 participants at risk
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Anal fistula
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
Infections and infestations
Anal abscess
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
Other adverse events
| Measure |
Cohort 1: 5mg EMODEPSIDE OD
n=6 participants at risk
6 subjects with LSF emodepside 5mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 2: 10mg EMODEPSIDE OD
n=6 participants at risk
6 subjects with LSF emodepside 10mg, OD
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Cohort 3: 10mg EMODEPSIDE BID
n=6 participants at risk
6 subjects with LSF emodepside 10mg, BID
LSF emodepside (BAY 44-4400) oral solution (1mg/mL)
|
Placebo Group
n=6 participants at risk
6 subjects with matching placebo (2 subjects per dose group)
|
|---|---|---|---|---|
|
Surgical and medical procedures
Sebaceous cyst excision
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
Immune system disorders
Allergy to animal
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
General disorders
Fatigue
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
General disorders
Malaise
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
General disorders
Medical device site erythema
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
Psychiatric disorders
Euphoric mood
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
16.7%
1/6 • Number of events 2 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
Psychiatric disorders
Nervousness
|
16.7%
1/6 • Number of events 2 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
Investigations
Hepatitis E antibody positive
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 3 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
33.3%
2/6 • Number of events 4 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Number of events 2 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
Eye disorders
Visual impairment
|
33.3%
2/6 • Number of events 3 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
16.7%
1/6 • Number of events 2 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
50.0%
3/6 • Number of events 3 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
Eye disorders
Vision blurred
|
16.7%
1/6 • Number of events 2 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
33.3%
2/6 • Number of events 2 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
Skin and subcutaneous tissue disorders
Acne
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
Infections and infestations
Nasopharyngitis
|
50.0%
3/6 • Number of events 3 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
50.0%
3/6 • Number of events 3 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
Infections and infestations
Ear infection
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
16.7%
1/6 • Number of events 2 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
Infections and infestations
Tonsilitis
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
|
Infections and infestations
Urethritis
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
16.7%
1/6 • Number of events 1 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
0.00%
0/6 • Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place