Trial Outcomes & Findings for A Study of Galcanezumab (LY2951742) in Healthy Chinese Participants (NCT NCT04085289)
NCT ID: NCT04085289
Last Updated: 2021-06-15
Results Overview
Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
8, 24, 48, 96, 120, 168, 216, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360 hours post-dose
Results posted on
2021-06-15
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received a single Subcutaneous (SC) dose of Placebo.
|
120 mg Galcanezumab SC
Participants received a single SC dose of 120 milligram (mg) Galcanezumab.
|
240 mg Galcanezumab SC
Participants received a single SC dose of 240 mg Galcanezumab.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
12
|
12
|
|
Overall Study
Received at Least One Dose of Study Drug
|
6
|
12
|
12
|
|
Overall Study
COMPLETED
|
6
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Participants received a single Subcutaneous (SC) dose of Placebo.
|
120 mg Galcanezumab SC
Participants received a single SC dose of 120 milligram (mg) Galcanezumab.
|
240 mg Galcanezumab SC
Participants received a single SC dose of 240 mg Galcanezumab.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Galcanezumab (LY2951742) in Healthy Chinese Participants
Baseline characteristics by cohort
| Measure |
Placebo
n=6 Participants
Participants received a single Subcutaneous (SC) dose of Placebo.
|
120 mg Galcanezumab SC
n=12 Participants
Participants received a single SC dose of 120 milligram (mg) Galcanezumab.
|
240 mg Galcanezumab SC
n=12 Participants
Participants received a single SC dose of 240 mg Galcanezumab.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
26.70 years
STANDARD_DEVIATION 4.18 • n=5 Participants
|
26.80 years
STANDARD_DEVIATION 6.03 • n=7 Participants
|
28.80 years
STANDARD_DEVIATION 4.09 • n=5 Participants
|
27.60 years
STANDARD_DEVIATION 4.91 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
23 Participants
n=4 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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
30 Participants
n=4 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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
30 Participants
n=4 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
|
|
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
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
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
|
|
Region of Enrollment
China
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8, 24, 48, 96, 120, 168, 216, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360 hours post-dosePopulation: All randomized participants who received at least one dose of Galcanezumab.
Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab.
Outcome measures
| Measure |
120 mg Galcanezumab SC
n=12 Participants
Participants received a single SC dose of 120 milligram (mg) Galcanezumab.
|
240 mg Galcanezumab SC
n=12 Participants
Participants received a single SC dose of 240 mg Galcanezumab.
|
|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab
|
12.6 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 23
|
27.2 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 23
|
PRIMARY outcome
Timeframe: 8, 24, 48, 96, 120, 168, 216, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360 hours post-dosePopulation: All randomized participants who received at least one dose of Galcanezumab.
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC\[0-∞\]) of Galcanezumab.
Outcome measures
| Measure |
120 mg Galcanezumab SC
n=12 Participants
Participants received a single SC dose of 120 milligram (mg) Galcanezumab.
|
240 mg Galcanezumab SC
n=12 Participants
Participants received a single SC dose of 240 mg Galcanezumab.
|
|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Galcanezumab
|
558 micrograms*day per milliliter(μg*day/mL)
Geometric Coefficient of Variation 36
|
1190 micrograms*day per milliliter(μg*day/mL)
Geometric Coefficient of Variation 27
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
120 mg Galcanezumab SC
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
240 mg Galcanezumab SC
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=6 participants at risk
Participants received a single Subcutaneous (SC) dose of Placebo.
|
120 mg Galcanezumab SC
n=12 participants at risk
Participants received a single SC dose of 120 milligram (mg) Galcanezumab.
|
240 mg Galcanezumab SC
n=12 participants at risk
Participants received a single SC dose of 240 mg Galcanezumab.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
Placebo
n=6 participants at risk
Participants received a single Subcutaneous (SC) dose of Placebo.
|
120 mg Galcanezumab SC
n=12 participants at risk
Participants received a single SC dose of 120 milligram (mg) Galcanezumab.
|
240 mg Galcanezumab SC
n=12 participants at risk
Participants received a single SC dose of 240 mg Galcanezumab.
|
|---|---|---|---|
|
Eye disorders
Dry eye
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Eye pain
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 3 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Asthenia
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
2/12 • Number of events 2 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site reaction
|
16.7%
1/6 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 2 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Swelling face
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
4/12 • Number of events 6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
2/12 • Number of events 2 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
3/12 • Number of events 3 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
41.7%
5/12 • Number of events 5 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
2/12 • Number of events 2 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Bacterial test
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood pressure decreased
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood pressure increased
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
3/12 • Number of events 8 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 2 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Heart rate increased
|
16.7%
1/6 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
2/12 • Number of events 2 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Lymphocyte percentage decreased
|
16.7%
1/6 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Monocyte percentage increased
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Neutrophil percentage increased
|
16.7%
1/6 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Protein urine present
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
2/12 • Number of events 2 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Urinary casts present
|
16.7%
1/6 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
2/12 • Number of events 3 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
White blood cell count decreased
|
16.7%
1/6 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
White blood cells urine positive
|
16.7%
1/6 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
2/12 • Number of events 2 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/2 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
2/6 • Number of events 2 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
2/12 • Number of events 2 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
2/12 • Number of events 2 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
3/12 • Number of events 3 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
1/12 • Number of events 1 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline through Study Completion (Up To 20 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60