Trial Outcomes & Findings for Relative Bioavailability Study of Emodepside IR-tablets and Solution (NCT NCT03383523)
NCT ID: NCT03383523
Last Updated: 2020-03-09
Results Overview
Means AUC from zero to 7 days (AUC0-7d) = means area under the plasma concentration-time curve from time zero (pre-dose) to 7 days. To create the curve, the following PK Timepoints have been collected: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3,4,6,8,12,36,48,72,120 and 168h post dose
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
77 participants
Primary outcome timeframe
means from zero to 7 days
Results posted on
2020-03-09
Participant Flow
Potential volunteers contacted HMR by telephone or email if they were interested in the study. HMR contacted eligible volunteers who had registered an interest in doing this study to invite them to take part. Recruitment of participants started on 26 October 2017 (FSFV) and finished on 26 March 2018 (LSLV).
screening details: to check they were healthy and eligible for the study, volunteers had a full examination at screening including physical and neurological examination, vital signs, 12-lead ECG monitoring, safety blood tests (hematology, biochemistry, coagulation and urinalysis), drug screen, alcohol breath test and serology
Participant milestones
| Measure |
Part 1a - Treatment A
5 mg emodepside LSF, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1a - Treatment B
5 mg emodepside IR-tablet #406, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1a - Treatment C
5 mg emodepside IR-tablet #416, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1b - Treatment D
5 mg emodepside IR-tablet #406, fed
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1b - Treatment E
5 mg emodepside IR-tablet #416, fed
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 2 - Treatment F
2 x 5 mg emodepside IR-tablet #406, fasted (may be tested or not, depending on the results of the part 1)
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 2 - Treatment G
2 x 5 mg emodepside IR-tablet #416, fasted (may be tested or not, depending on the results of the part 1)
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
10
|
12
|
11
|
12
|
10
|
|
Overall Study
COMPLETED
|
10
|
11
|
9
|
12
|
11
|
12
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Relative Bioavailability Study of Emodepside IR-tablets and Solution
Baseline characteristics by cohort
| Measure |
Part 1a - Treatment A
n=11 Participants
5 mg emodepside LSF, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1a - Treatment B
n=11 Participants
5 mg emodepside IR-tablet #406, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1a - Treatment C
n=10 Participants
5 mg emodepside IR-tablet #416, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1b - Treatment D
n=12 Participants
5 mg emodepside IR-tablet #406, fed
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1b - Treatment E
n=11 Participants
5 mg emodepside IR-tablet #416, fed
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 2 - Treatment F
n=12 Participants
2 x 5 mg emodepside IR-tablet #406, fasted (may be tested or not, depending on the results of the part 1)
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 2 - Treatment G
n=10 Participants
2 x 5 mg emodepside IR-tablet #416, fasted (may be tested or not, depending on the results of the part 1)
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
77 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Age, Continuous
|
30 years
n=5 Participants
|
32.4 years
n=7 Participants
|
32.2 years
n=5 Participants
|
32.6 years
n=4 Participants
|
30.5 years
n=21 Participants
|
30.5 years
n=10 Participants
|
29.8 years
n=115 Participants
|
31.1 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
77 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
77 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
77 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United Kingdom
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
10 participants
n=5 Participants
|
12 participants
n=4 Participants
|
11 participants
n=21 Participants
|
12 participants
n=10 Participants
|
10 participants
n=115 Participants
|
77 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: means from zero to 7 daysMeans AUC from zero to 7 days (AUC0-7d) = means area under the plasma concentration-time curve from time zero (pre-dose) to 7 days. To create the curve, the following PK Timepoints have been collected: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3,4,6,8,12,36,48,72,120 and 168h post dose
Outcome measures
| Measure |
Part 1a - Treatment A
n=11 Participants
5 mg emodepside LSF, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1a - Treatment B
n=11 Participants
5 mg emodepside IR-tablet #406, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1a - Treatment C
n=10 Participants
5 mg emodepside IR-tablet #416, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1b - Treatment D
n=12 Participants
5 mg emodepside IR-tablet #406, fed
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1b - Treatment E
n=11 Participants
5 mg emodepside IR-tablet #416, fed
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 2 - Treatment F
n=12 Participants
2 x 5 mg emodepside IR-tablet #406, fasted (may be tested or not, depending on the results of the part 1)
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 2 - Treatment G
n=10 Participants
2 x 5 mg emodepside IR-tablet #416, fasted (may be tested or not, depending on the results of the part 1)
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
|---|---|---|---|---|---|---|---|
|
PK (AUC0-7d) of Two New Tablet Formulations of Emodepside in Comparison to the Liquid Formulation (LSF) Oral Solution.
|
1215 h.ng/ml
Geometric Coefficient of Variation 37.2
|
852 h.ng/ml
Geometric Coefficient of Variation 19.1
|
931 h.ng/ml
Geometric Coefficient of Variation 23.3
|
674 h.ng/ml
Geometric Coefficient of Variation 32.1
|
733 h.ng/ml
Geometric Coefficient of Variation 34.9
|
1609 h.ng/ml
Geometric Coefficient of Variation 35.9
|
1943 h.ng/ml
Geometric Coefficient of Variation 26.5
|
PRIMARY outcome
Timeframe: 7 daysCmax means maximum observed plasma concentration. To create the PK curve, the following PK timepoints have been collected: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3,4,6,8,12,36,48,72,120 and 168h post dose
Outcome measures
| Measure |
Part 1a - Treatment A
n=11 Participants
5 mg emodepside LSF, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1a - Treatment B
n=11 Participants
5 mg emodepside IR-tablet #406, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1a - Treatment C
n=10 Participants
5 mg emodepside IR-tablet #416, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1b - Treatment D
n=12 Participants
5 mg emodepside IR-tablet #406, fed
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1b - Treatment E
n=11 Participants
5 mg emodepside IR-tablet #416, fed
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 2 - Treatment F
n=12 Participants
2 x 5 mg emodepside IR-tablet #406, fasted (may be tested or not, depending on the results of the part 1)
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 2 - Treatment G
n=10 Participants
2 x 5 mg emodepside IR-tablet #416, fasted (may be tested or not, depending on the results of the part 1)
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
|---|---|---|---|---|---|---|---|
|
PK (Cmax) of Two New Tablet Formulations of Emodepside in Comparison to the Liquid Formulation (LSF) Oral Solution.
|
88.5 ng/ml
Geometric Coefficient of Variation 20.1
|
41.9 ng/ml
Geometric Coefficient of Variation 20.0
|
54.2 ng/ml
Geometric Coefficient of Variation 35.3
|
27.1 ng/ml
Geometric Coefficient of Variation 26.8
|
36.2 ng/ml
Geometric Coefficient of Variation 39.8
|
71.7 ng/ml
Geometric Coefficient of Variation 28.5
|
135 ng/ml
Geometric Coefficient of Variation 35.3
|
SECONDARY outcome
Timeframe: 7 daysnumber of participants with treatment-related adverse events
Outcome measures
| Measure |
Part 1a - Treatment A
n=11 Participants
5 mg emodepside LSF, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1a - Treatment B
n=11 Participants
5 mg emodepside IR-tablet #406, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1a - Treatment C
n=10 Participants
5 mg emodepside IR-tablet #416, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1b - Treatment D
n=12 Participants
5 mg emodepside IR-tablet #406, fed
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1b - Treatment E
n=11 Participants
5 mg emodepside IR-tablet #416, fed
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 2 - Treatment F
n=12 Participants
2 x 5 mg emodepside IR-tablet #406, fasted (may be tested or not, depending on the results of the part 1)
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 2 - Treatment G
n=10 Participants
2 x 5 mg emodepside IR-tablet #416, fasted (may be tested or not, depending on the results of the part 1)
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
|---|---|---|---|---|---|---|---|
|
Safety and Tolerability as Measured by Number of Participants With Treatment-related Adverse Events
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 7 daysnumber of participants with abnormal physical examination (PE) findings. Standard examination done on head, ears, eyes, nose, thyroid, lymph node, back, neck, lungs, skin, abdomen, chest. The details are listed in protocol section 8.11.3
Outcome measures
| Measure |
Part 1a - Treatment A
n=11 Participants
5 mg emodepside LSF, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1a - Treatment B
n=11 Participants
5 mg emodepside IR-tablet #406, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1a - Treatment C
n=10 Participants
5 mg emodepside IR-tablet #416, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1b - Treatment D
n=12 Participants
5 mg emodepside IR-tablet #406, fed
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1b - Treatment E
n=11 Participants
5 mg emodepside IR-tablet #416, fed
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 2 - Treatment F
n=12 Participants
2 x 5 mg emodepside IR-tablet #406, fasted (may be tested or not, depending on the results of the part 1)
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 2 - Treatment G
n=10 Participants
2 x 5 mg emodepside IR-tablet #416, fasted (may be tested or not, depending on the results of the part 1)
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
|---|---|---|---|---|---|---|---|
|
Safety and Tolerability as Measured by Number of Participants With Physical Examination Findings
number of subject with abnormal PE findings
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability as Measured by Number of Participants With Physical Examination Findings
number subject with clinically significant finding
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 7 daysNumber of participants with abnormal neurological examination (NE) findings
Outcome measures
| Measure |
Part 1a - Treatment A
n=11 Participants
5 mg emodepside LSF, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1a - Treatment B
n=11 Participants
5 mg emodepside IR-tablet #406, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1a - Treatment C
n=10 Participants
5 mg emodepside IR-tablet #416, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1b - Treatment D
n=12 Participants
5 mg emodepside IR-tablet #406, fed
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1b - Treatment E
n=11 Participants
5 mg emodepside IR-tablet #416, fed
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 2 - Treatment F
n=12 Participants
2 x 5 mg emodepside IR-tablet #406, fasted (may be tested or not, depending on the results of the part 1)
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 2 - Treatment G
n=10 Participants
2 x 5 mg emodepside IR-tablet #416, fasted (may be tested or not, depending on the results of the part 1)
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
|---|---|---|---|---|---|---|---|
|
Safety and Tolerability as Measured by Number of Participants With Neurological Examination Findings
number of subject with abnormal NE findings
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability as Measured by Number of Participants With Neurological Examination Findings
number subject with clinically significant finding
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 7 daysnumber of participants with vital signs (VS) findings. The vital signs ranges are the following Supine Systolic BP : 85-160mm HG, Supine Diastolic BP: 40-90mm HG, Supine HR: 35-100 beats/min. Details are described in the protocol section 8.11.2
Outcome measures
| Measure |
Part 1a - Treatment A
n=11 Participants
5 mg emodepside LSF, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1a - Treatment B
n=11 Participants
5 mg emodepside IR-tablet #406, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1a - Treatment C
n=10 Participants
5 mg emodepside IR-tablet #416, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1b - Treatment D
n=12 Participants
5 mg emodepside IR-tablet #406, fed
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1b - Treatment E
n=11 Participants
5 mg emodepside IR-tablet #416, fed
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 2 - Treatment F
n=12 Participants
2 x 5 mg emodepside IR-tablet #406, fasted (may be tested or not, depending on the results of the part 1)
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 2 - Treatment G
n=10 Participants
2 x 5 mg emodepside IR-tablet #416, fasted (may be tested or not, depending on the results of the part 1)
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
|---|---|---|---|---|---|---|---|
|
Safety and Tolerability as Measured by Number of Participants With Vital Signs Findings
number of subject with VS findings
|
0 participants
|
1 participants
|
2 participants
|
2 participants
|
3 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability as Measured by Number of Participants With Vital Signs Findings
number subject with clinically significant finding
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 7 daysnumber of participants with 12-lead ECG findings. The ECG reference ranges used are the following: ventricular rate: 45-100beats/min, PR interval:120-220msec, QRS:\<120msec, QTc:\<430msec
Outcome measures
| Measure |
Part 1a - Treatment A
n=11 Participants
5 mg emodepside LSF, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1a - Treatment B
n=11 Participants
5 mg emodepside IR-tablet #406, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1a - Treatment C
n=10 Participants
5 mg emodepside IR-tablet #416, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1b - Treatment D
n=12 Participants
5 mg emodepside IR-tablet #406, fed
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1b - Treatment E
n=11 Participants
5 mg emodepside IR-tablet #416, fed
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 2 - Treatment F
n=12 Participants
2 x 5 mg emodepside IR-tablet #406, fasted (may be tested or not, depending on the results of the part 1)
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 2 - Treatment G
n=10 Participants
2 x 5 mg emodepside IR-tablet #416, fasted (may be tested or not, depending on the results of the part 1)
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
|---|---|---|---|---|---|---|---|
|
Safety and Tolerability as Measured by Number of Participants With 12-lead ECG Findings
number of subject with abnormal ECG findings
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability as Measured by Number of Participants With 12-lead ECG Findings
number subject with clinically significant finding
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 7 daysnumber of participants with relevant abnormal laboratory tests results
Outcome measures
| Measure |
Part 1a - Treatment A
n=11 Participants
5 mg emodepside LSF, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1a - Treatment B
n=11 Participants
5 mg emodepside IR-tablet #406, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1a - Treatment C
n=10 Participants
5 mg emodepside IR-tablet #416, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1b - Treatment D
n=12 Participants
5 mg emodepside IR-tablet #406, fed
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1b - Treatment E
n=11 Participants
5 mg emodepside IR-tablet #416, fed
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 2 - Treatment F
n=12 Participants
2 x 5 mg emodepside IR-tablet #406, fasted (may be tested or not, depending on the results of the part 1)
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 2 - Treatment G
n=10 Participants
2 x 5 mg emodepside IR-tablet #416, fasted (may be tested or not, depending on the results of the part 1)
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
|---|---|---|---|---|---|---|---|
|
Safety and Tolerability as Measured by Number of Participants With Clinical Laboratory Tests Findings
number subject with clinically significant finding
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety and Tolerability as Measured by Number of Participants With Clinical Laboratory Tests Findings
number of subject with abnormal lab values
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Part 1a - Treatment A
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1a - Treatment B
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1a - Treatment C
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1b - Treatment D
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1b - Treatment E
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2 - Treatment F
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2 - Treatment G
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1a - Treatment A
n=11 participants at risk
5 mg emodepside LSF, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1a - Treatment B
n=11 participants at risk
5 mg emodepside IR-tablet #406, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1a - Treatment C
n=10 participants at risk
5 mg emodepside IR-tablet #416, fasted
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1b - Treatment D
n=12 participants at risk
5 mg emodepside IR-tablet #406, fed
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 1b - Treatment E
n=11 participants at risk
5 mg emodepside IR-tablet #416, fed
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 2 - Treatment F
n=12 participants at risk
2 x 5 mg emodepside IR-tablet #406, fasted (may be tested or not, depending on the results of the part 1)
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
Part 2 - Treatment G
n=10 participants at risk
2 x 5 mg emodepside IR-tablet #416, fasted (may be tested or not, depending on the results of the part 1)
Emodepside (BAY 44-4400): 2 tablets compared to the liquid formulation
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
9.1%
1/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
8.3%
1/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
27.3%
3/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
20.0%
2/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
9.1%
1/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
10.0%
1/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
10.0%
1/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
|
Infections and infestations
nasopharyngitis
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
9.1%
1/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
10.0%
1/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
9.1%
1/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
|
Eye disorders
visual impairment
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
10.0%
1/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
10.0%
1/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
|
General disorders
catheter site
|
9.1%
1/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
|
Skin and subcutaneous tissue disorders
pigmentation disorder
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
9.1%
1/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
10.0%
1/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
10.0%
1/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
|
Nervous system disorders
presyncope
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
9.1%
1/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
|
Nervous system disorders
somnolence
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
9.1%
1/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
9.1%
1/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
9.1%
1/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
|
Gastrointestinal disorders
toothache
|
9.1%
1/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
10.0%
1/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
|
Gastrointestinal disorders
abdominal disconfort
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
10.0%
1/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
|
General disorders
feeling of relaxation
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/11 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
0.00%
0/12 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
10.0%
1/10 • Adverse Events (AEs) were reported from screening (up to 28 days before dosing) up to Follow up visit (7 days after dosing)
|
Additional Information
Jean Yves Gillon
Drugs for Neglected Diseases Initiative
Phone: +41229069232
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee There is an agreement between the PI and the sponsor that restricts the PI's rights to discuss or publish trial results after the trial is completed.
- Publication restrictions are in place
Restriction type: OTHER