Trial Outcomes & Findings for A Study of Lasmiditan in Healthy Chinese Participants (NCT NCT04081324)
NCT ID: NCT04081324
Last Updated: 2021-07-01
Results Overview
PK: Area Under the Concentration Versus Time Curve from time zero to infinity AUC(0-∞) of Lasmiditan after single dose (Day 1).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose
Results posted on
2021-07-01
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received placebo administered orally on Day 1 and repeated doses on Days 4 to 10 (7 days of dosing).
|
50 Milligram (mg) Lasmiditan
Participants received 50 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 50 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
|
100 mg Lasmiditan
Participants received 100 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 100 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
|
200 mg Lasmiditan
Participants received 200 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 200 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
10
|
10
|
10
|
|
Overall Study
Received At Least One Dose of Study Drug
|
6
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
6
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Lasmiditan in Healthy Chinese Participants
Baseline characteristics by cohort
| Measure |
Placebo
n=6 Participants
Participants received placebo administered orally on Day 1 and repeated doses on Days 4 to 10 (7 days of dosing).
|
50 mg Lasmiditan
n=10 Participants
Participants received 50 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 50 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
|
100 mg Lasmiditan
n=10 Participants
Participants received 100 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 100 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
|
200 mg Lasmiditan
n=10 Participants
Participants received 200 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 200 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
31.20 years
STANDARD_DEVIATION 9.75 • n=99 Participants
|
31.90 years
STANDARD_DEVIATION 5.82 • n=107 Participants
|
33.40 years
STANDARD_DEVIATION 4.88 • n=206 Participants
|
30.00 years
STANDARD_DEVIATION 5.66 • n=7 Participants
|
31.70 years
STANDARD_DEVIATION 6.19 • n=31 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
27 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
36 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
36 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
China
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
36 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dosePopulation: All randomized participants who received at least one dose of study drug and had evaluable pharmacokinetic data.
PK: Area Under the Concentration Versus Time Curve from time zero to infinity AUC(0-∞) of Lasmiditan after single dose (Day 1).
Outcome measures
| Measure |
50 mg Lasmiditan
n=10 Participants
Participants received 50 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 50 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
|
100 mg Lasmiditan
n=10 Participants
Participants received 100 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 100 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
|
200 mg Lasmiditan
n=10 Participants
Participants received 200 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 200 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-∞) of Lasmiditan
|
385 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 48
|
829 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 34
|
1990 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 34
|
PRIMARY outcome
Timeframe: Day 1 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, and 24 hours post-dose) and Day 10 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose)Population: All randomized participants who received at least one dose of study drug and had evaluable pharmacokinetic data.
PK: AUCτ of of Lasmiditan was calculated based on the of Lasmiditan plasma concentration time curve from time 0 hour (hr) to time 24 hr (tau \[τ\]) when Lasmiditan was administered after single dose (day 1) and multiple doses (Day 10).
Outcome measures
| Measure |
50 mg Lasmiditan
n=10 Participants
Participants received 50 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 50 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
|
100 mg Lasmiditan
n=10 Participants
Participants received 100 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 100 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
|
200 mg Lasmiditan
n=10 Participants
Participants received 200 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 200 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
|
|---|---|---|---|
|
PK: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of of Lasmiditan
Day 1
|
378 ng*h/mL
Geometric Coefficient of Variation 47
|
809 ng*h/mL
Geometric Coefficient of Variation 34
|
1950 ng*h/mL
Geometric Coefficient of Variation 34
|
|
PK: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of of Lasmiditan
Day 10
|
429 ng*h/mL
Geometric Coefficient of Variation 36
|
898 ng*h/mL
Geometric Coefficient of Variation 28
|
2140 ng*h/mL
Geometric Coefficient of Variation 33
|
PRIMARY outcome
Timeframe: Day 1 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, and 24 hours post-dose) and Day 10 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose)Population: All randomized participants who received at least one dose of study drug and had evaluable pharmacokinetic data.
PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan after single dose (day 1) and multiple doses (Day 10).
Outcome measures
| Measure |
50 mg Lasmiditan
n=10 Participants
Participants received 50 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 50 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
|
100 mg Lasmiditan
n=10 Participants
Participants received 100 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 100 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
|
200 mg Lasmiditan
n=10 Participants
Participants received 200 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 200 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
|
|---|---|---|---|
|
PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan
Day 1
|
69.6 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 48
|
154 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 37
|
359 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 33
|
|
PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan
Day 10
|
78.8 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 50
|
187 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 28
|
394 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 37
|
PRIMARY outcome
Timeframe: Day 1 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, and 24 hours post-dose) and Day 10 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose)Population: All randomized participants who received at least one dose of study drug and had evaluable pharmacokinetic data.
PK: Time to Maximum Observed Plasma Concentration (tmax) of Lasmiditan after single dose (Day 1) and multiple doses (Day 10).
Outcome measures
| Measure |
50 mg Lasmiditan
n=10 Participants
Participants received 50 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 50 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
|
100 mg Lasmiditan
n=10 Participants
Participants received 100 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 100 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
|
200 mg Lasmiditan
n=10 Participants
Participants received 200 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 200 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
|
|---|---|---|---|
|
PK: Time to Maximum Observed Plasma Concentration (Tmax) of Lasmiditan
Day 1
|
1.50 hours (h)
Interval 0.5 to 2.5
|
1.50 hours (h)
Interval 0.5 to 2.5
|
1.50 hours (h)
Interval 1.0 to 2.97
|
|
PK: Time to Maximum Observed Plasma Concentration (Tmax) of Lasmiditan
Day 10
|
1.75 hours (h)
Interval 0.5 to 2.5
|
1.50 hours (h)
Interval 1.0 to 2.0
|
1.50 hours (h)
Interval 0.5 to 2.5
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
50 mg Lasmiditan
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
100 mg Lasmiditan
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
200 mg Lasmiditan
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=6 participants at risk
Participants received placebo administered orally on Day 1 and repeated doses on Days 4 to 10 (7 days of dosing).
|
50 mg Lasmiditan
n=10 participants at risk
Participants received 50 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 50 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
|
100 mg Lasmiditan
n=10 participants at risk
Participants received 100 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 100 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
|
200 mg Lasmiditan
n=10 participants at risk
Participants received 200 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 200 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrioventricular block first degree
|
16.7%
1/6 • Number of events 2 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
20.0%
2/10 • Number of events 2 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Sinus bradycardia
|
16.7%
1/6 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
50.0%
5/10 • Number of events 6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
50.0%
5/10 • Number of events 10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
20.0%
2/10 • Number of events 2 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 2 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
20.0%
2/10 • Number of events 3 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 3 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
30.0%
3/10 • Number of events 11 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
20.0%
2/10 • Number of events 2 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
16.7%
1/6 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
30.0%
3/10 • Number of events 3 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Puncture site swelling
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood pressure decreased
|
16.7%
1/6 • Number of events 2 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
30.0%
3/10 • Number of events 5 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood pressure increased
|
16.7%
1/6 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Body temperature increased
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 4 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 2 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Heart rate decreased
|
16.7%
1/6 • Number of events 4 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
60.0%
6/10 • Number of events 10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
60.0%
6/10 • Number of events 16 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
20.0%
2/10 • Number of events 2 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Heart rate increased
|
16.7%
1/6 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
20.0%
2/10 • Number of events 2 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Lymphocyte percentage decreased
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
20.0%
2/10 • Number of events 2 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil percentage decreased
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil percentage increased
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Protein urine present
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Red blood cells urine positive
|
16.7%
1/6 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Urinary casts
|
16.7%
1/6 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
20.0%
2/10 • Number of events 2 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
20.0%
2/10 • Number of events 2 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Number of events 2 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
50.0%
5/10 • Number of events 11 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
50.0%
5/10 • Number of events 13 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 3 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
30.0%
3/10 • Number of events 7 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
90.0%
9/10 • Number of events 29 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
20.0%
2/10 • Number of events 2 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal disorder
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline, Up to 4 months
All randomized participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60