Trial Outcomes & Findings for A Ph1 Study in Healthy Male Japanese and Caucasian After Single and Multiple Doses of D5884(Omega-3-carboxylic Acids) (NCT NCT02209766)
NCT ID: NCT02209766
Last Updated: 2016-05-17
Results Overview
Number of patients with treatment-emergent adverse events (TEAEs), by treatment (Safety Analysis Set)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
86 participants
Primary outcome timeframe
from first dosing (Day1) until follow-up (Day25)
Results posted on
2016-05-17
Participant Flow
86 male subjects were screened.
Of the 86 subjects, 43 did not meet the inclusion/exclusion criteria, 14 decided not to participate in the study and 5 had other reasons for declining participation in the study.
Participant milestones
| Measure |
2 g D5884 Japanese
Single dose followed by once daily for 14 consecutive days
|
2 g D5884 Japanese Placebo
Single dose followed by once daily for 14 consecutive days
|
4 g D5884 Japanese
Single dose followed by once daily for 14 consecutive days
|
4g D5844 Japanese Placebo
Single dose followed by once daily for 14 consecutive days
|
4g D5884 Caucasian
Single dose followed by once daily for 14 consecutive days
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
6
|
3
|
6
|
|
Overall Study
COMPLETED
|
6
|
3
|
6
|
2
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
2 g D5884 Japanese
Single dose followed by once daily for 14 consecutive days
|
2 g D5884 Japanese Placebo
Single dose followed by once daily for 14 consecutive days
|
4 g D5884 Japanese
Single dose followed by once daily for 14 consecutive days
|
4g D5844 Japanese Placebo
Single dose followed by once daily for 14 consecutive days
|
4g D5884 Caucasian
Single dose followed by once daily for 14 consecutive days
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Ph1 Study in Healthy Male Japanese and Caucasian After Single and Multiple Doses of D5884(Omega-3-carboxylic Acids)
Baseline characteristics by cohort
| Measure |
2 g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4 g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4 g D5884 Caucasian
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
Placebo Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
26.7 years
STANDARD_DEVIATION 8.71 • n=93 Participants
|
28.3 years
STANDARD_DEVIATION 6.15 • n=4 Participants
|
34.0 years
STANDARD_DEVIATION 5.25 • n=27 Participants
|
32.3 years
STANDARD_DEVIATION 6.12 • n=483 Participants
|
30.3 years
STANDARD_DEVIATION 6.93 • n=36 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
24 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
18 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
|
Weight
|
60.42 kg
STANDARD_DEVIATION 8.109 • n=93 Participants
|
69.08 kg
STANDARD_DEVIATION 7.059 • n=4 Participants
|
72.92 kg
STANDARD_DEVIATION 10.169 • n=27 Participants
|
62.63 kg
STANDARD_DEVIATION 6.371 • n=483 Participants
|
66.26 kg
STANDARD_DEVIATION 9.078 • n=36 Participants
|
|
BMI
|
20.67 kg/m^2
STANDARD_DEVIATION 0.852 • n=93 Participants
|
22.67 kg/m^2
STANDARD_DEVIATION 1.517 • n=4 Participants
|
22.55 kg/m^2
STANDARD_DEVIATION 1.724 • n=27 Participants
|
21.40 kg/m^2
STANDARD_DEVIATION 1.370 • n=483 Participants
|
21.82 kg/m^2
STANDARD_DEVIATION 1.559 • n=36 Participants
|
PRIMARY outcome
Timeframe: from first dosing (Day1) until follow-up (Day25)Number of patients with treatment-emergent adverse events (TEAEs), by treatment (Safety Analysis Set)
Outcome measures
| Measure |
2g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4g D5885 Caucasian
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
Placebo Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
|---|---|---|---|---|
|
Number of Patients With Treatment-emergent Adverse Events (TEAEs), by Treatment (Safety Analysis Set)
TEAEs
|
2 subjects
|
2 subjects
|
5 subjects
|
2 subjects
|
|
Number of Patients With Treatment-emergent Adverse Events (TEAEs), by Treatment (Safety Analysis Set)
TEAEs leading to discontinued
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Number of Patients With Treatment-emergent Adverse Events (TEAEs), by Treatment (Safety Analysis Set)
Serious TEAEs
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: Day1-3, 4, 7, 11, 14, 17-18 and 25Outcome measures
| Measure |
2g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4g D5885 Caucasian
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
Placebo Japanese
Single dose followed by once daily for 14 consecutive days
|
|---|---|---|---|---|
|
Cmax in Plasma Baseline-adjusted Total Eicosapentaenoic Acid (EPA), Single Dose
|
82.22 μg/mL
Geometric Coefficient of Variation 45.10
|
220.0 μg/mL
Geometric Coefficient of Variation 17.70
|
158.1 μg/mL
Geometric Coefficient of Variation 34.98
|
—
|
SECONDARY outcome
Timeframe: Day1-3, 4, 7, 11, 14, 17-18 and 25Outcome measures
| Measure |
2g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4g D5885 Caucasian
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
Placebo Japanese
Single dose followed by once daily for 14 consecutive days
|
|---|---|---|---|---|
|
Tmax in Plasma Baseline-adjusted Total EPA, Single Dose
|
5.50 h
Interval 5.0 to 6.0
|
5.00 h
Interval 5.0 to 6.0
|
6.00 h
Interval 5.0 to 8.0
|
—
|
SECONDARY outcome
Timeframe: Day1-3, 4, 7, 11, 14, 17-18 and 25Outcome measures
| Measure |
2g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4g D5885 Caucasian
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
Placebo Japanese
Single dose followed by once daily for 14 consecutive days
|
|---|---|---|---|---|
|
Cmax in Plasma Baseline-adjusted Total Docosahexaenoic Acid (DHA), Single Dose
|
32.04 μg/mL
Geometric Coefficient of Variation 69.51
|
90.10 μg/mL
Geometric Coefficient of Variation 21.50
|
63.63 μg/mL
Geometric Coefficient of Variation 46.12
|
—
|
SECONDARY outcome
Timeframe: Day1-3, 4, 7, 11, 14, 17-18 and 25Outcome measures
| Measure |
2g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4g D5885 Caucasian
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
Placebo Japanese
Single dose followed by once daily for 14 consecutive days
|
|---|---|---|---|---|
|
Tmax in Plasma Baseline-adjusted Total DHA, Single Dose
|
5.00 h
Interval 4.0 to 6.0
|
5.00 h
Interval 5.0 to 6.0
|
5.00 h
Interval 5.0 to 6.0
|
—
|
SECONDARY outcome
Timeframe: Day1-3, 4, 7, 11, 14, 17-18 and 25Outcome measures
| Measure |
2g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4g D5885 Caucasian
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
Placebo Japanese
Single dose followed by once daily for 14 consecutive days
|
|---|---|---|---|---|
|
Cmax in Plasma Baseline-adjusted Total EPA, Multiple Dose
|
157.4 μg/mL
Geometric Coefficient of Variation 32.73
|
314.8 μg/mL
Geometric Coefficient of Variation 26.09
|
238.8 μg/mL
Geometric Coefficient of Variation 33.21
|
—
|
SECONDARY outcome
Timeframe: Day1-3, 4, 7, 11, 14, 17-18 and 25Outcome measures
| Measure |
2g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4g D5885 Caucasian
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
Placebo Japanese
Single dose followed by once daily for 14 consecutive days
|
|---|---|---|---|---|
|
Tmax in Plasma Baseline-adjusted Total EPA, Multiple Dose
|
5.00 h
Interval 5.0 to 6.0
|
5.50 h
Interval 5.0 to 6.0
|
5.00 h
Interval 5.0 to 7.0
|
—
|
SECONDARY outcome
Timeframe: Day1-3, 4, 7, 11, 14, 17-18 and 25Outcome measures
| Measure |
2g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4g D5885 Caucasian
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
Placebo Japanese
Single dose followed by once daily for 14 consecutive days
|
|---|---|---|---|---|
|
Cmax in Plasma Baseline-adjusted Total DHA, Multiple Dose
|
58.47 μg/mL
Geometric Coefficient of Variation 49.15
|
88.21 μg/mL
Geometric Coefficient of Variation 89.54
|
101.1 μg/mL
Geometric Coefficient of Variation 34.06
|
—
|
SECONDARY outcome
Timeframe: Day1-3, 4, 7, 11, 14, 17-18 and 25Outcome measures
| Measure |
2g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4g D5885 Caucasian
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
Placebo Japanese
Single dose followed by once daily for 14 consecutive days
|
|---|---|---|---|---|
|
Tmax in Plasma Baseline-adjusted Total DHA, Multiple Dose
|
5.00 h
Interval 5.0 to 6.0
|
6.00 h
Interval 5.0 to 6.0
|
5.00 h
Interval 5.0 to 6.0
|
—
|
SECONDARY outcome
Timeframe: Day1-3, 4, 7, 11, 14, 17-18 and 25Outcome measures
| Measure |
2g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4g D5885 Caucasian
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
Placebo Japanese
Single dose followed by once daily for 14 consecutive days
|
|---|---|---|---|---|
|
AUC(0-tau) in Plasma Baseline-adjusted Total DHA, Multiple Dose
|
531.2 μg*h/mL
Geometric Coefficient of Variation 75.81
|
621.9 μg*h/mL
Geometric Coefficient of Variation 278.9
|
1044 μg*h/mL
Geometric Coefficient of Variation 48.00
|
—
|
SECONDARY outcome
Timeframe: Day1-3, 4, 7, 11, 14, 17-18 and 25Outcome measures
| Measure |
2g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4g D5885 Caucasian
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
Placebo Japanese
Single dose followed by once daily for 14 consecutive days
|
|---|---|---|---|---|
|
AUC(0-tau) in Plasma Baseline-adjusted Total EPA, Multiple Dose
|
2072 μg*h/mL
Geometric Coefficient of Variation 39.29
|
4067 μg*h/mL
Geometric Coefficient of Variation 43.52
|
3136 μg*h/mL
Geometric Coefficient of Variation 28.93
|
—
|
SECONDARY outcome
Timeframe: Day1-3, 4, 7, 11, 14, 17-18 and 25Outcome measures
| Measure |
2g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4g D5885 Caucasian
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
Placebo Japanese
Single dose followed by once daily for 14 consecutive days
|
|---|---|---|---|---|
|
AUC(0-tau) in Plasma Baseline-adjusted Total Docosahexaenoic Acid (DHA), Single Dose
|
138.2 μg*h/mL
Geometric Coefficient of Variation 80.07
|
432.9 μg*h/mL
Geometric Coefficient of Variation 39.97
|
783.2 μg*h/mL
Geometric Coefficient of Variation 78.67
|
—
|
SECONDARY outcome
Timeframe: Day1-3, 4, 7, 11, 14, 17-18 and 25Outcome measures
| Measure |
2g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4g D5884 Japanese
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
4g D5885 Caucasian
n=6 Participants
Single dose followed by once daily for 14 consecutive days
|
Placebo Japanese
Single dose followed by once daily for 14 consecutive days
|
|---|---|---|---|---|
|
AUC(0-tau) in Plasma Baseline-adjusted Total Eicosapentaenoic Acid (EPA), Single Dose
|
1108 μg*h/mL
Geometric Coefficient of Variation 38.37
|
2213 μg*h/mL
Geometric Coefficient of Variation 31.67
|
2105 μg*h/mL
Geometric Coefficient of Variation 25.70
|
—
|
Adverse Events
2 g D4884 Japanese
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
4 g D4884 Japanese
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
4 g D4884 Caucasian
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo Japanese
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
2 g D4884 Japanese
n=6 participants at risk
|
4 g D4884 Japanese
n=6 participants at risk
|
4 g D4884 Caucasian
n=6 participants at risk
|
Placebo Japanese
n=6 participants at risk
Single dose followed by once daily for 14 consecutive days
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.
|
83.3%
5/6 • Number of events 5 • AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.
|
0.00%
0/6 • AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.
|
|
General disorders
Feeling abnormal
|
0.00%
0/6 • AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.
|
0.00%
0/6 • AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.
|
0.00%
0/6 • AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.
|
|
Investigations
ALT increased
|
33.3%
2/6 • Number of events 2 • AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.
|
33.3%
2/6 • Number of events 2 • AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.
|
|
Investigations
AST increased
|
16.7%
1/6 • Number of events 1 • AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.
|
0.00%
0/6 • AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.
|
0.00%
0/6 • AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.
|
0.00%
0/6 • AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.
|
0.00%
0/6 • AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.
|
0.00%
0/6 • AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.
|
0.00%
0/6 • AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.
|
0.00%
0/6 • AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.
|
16.7%
1/6 • Number of events 1 • AEs will be collected from randomisation, throughout the treatment period and including the follow-up period. SAEs will be recorded from the time of informed consent.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60