Trial Outcomes & Findings for A Study of LY3526318 in Healthy Women (NCT NCT04183283)
NCT ID: NCT04183283
Last Updated: 2025-10-06
Results Overview
CA-induced DBF was measured by laser doppler imaging (LDI). Least Squares (LS) mean was determined by analysis of variance (ANOVA) model with treatment, period, sequence, time and treatment\*time interaction as fixed factors and subject within sequence as a random factor.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
3 hours post LY3526318 dose (pre-CA challenge), 3.3 hours post LY3526318 dose (post-CA challenge)
Results posted on
2025-10-06
Participant Flow
Participant milestones
| Measure |
Sequence 1: Placebo,10 mg LY3526318,100 mg LY3526318,30 mg LY3526318
Period 1: Participant received placebo orally.
Period 2: Participants received 10 milligrams (mg) LY3526318 orally.
Period 3: Participants received 100 mg LY3526318 orally.
Period 4: Participants received 30 mg LY3526318 orally.
|
Sequence 2: 10 mg LY3526318,30 mg LY3526318, Placebo,100 mg LY3526318
Period 1: Participant received 10 mg LY3526318 orally.
Period 2: Participants received 30 mg LY3526318 orally.
Period 3: Participants received Placebo orally.
Period 4: Participants received 100 mg LY3526318 orally.
|
Sequence 3: 30 mg LY3526318,100 mg LY3526318,10 mg LY3526318, Placebo
Period 1: Participant received 30 mg LY3526318 orally.
Period 2: Participants received 100 mg LY3526318 orally.
Period 3: Participants received 10 mg LY3526318 orally.
Period 4: Participants received Placebo orally.
|
Sequence 4: 100 mg LY3526318, Placebo, 30 mg LY3526318,10 mg LY3526318
Period 1: Participant received 100 mg LY3526318 orally.
Period 2: Participants received Placebo orally.
Period 3: Participants received 30 mg LY3526318 orally.
Period 4: Participants received 10 mg LY3526318 orally.
|
|---|---|---|---|---|
|
Period 1
STARTED
|
4
|
4
|
4
|
4
|
|
Period 1
Received at Least One Dose of Study Drug
|
4
|
4
|
4
|
4
|
|
Period 1
COMPLETED
|
4
|
3
|
4
|
4
|
|
Period 1
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Washout 1(14 Days)
STARTED
|
4
|
3
|
4
|
4
|
|
Washout 1(14 Days)
COMPLETED
|
4
|
3
|
4
|
3
|
|
Washout 1(14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
|
Period 2
STARTED
|
4
|
3
|
4
|
3
|
|
Period 2
COMPLETED
|
4
|
3
|
4
|
3
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout 2 (14 Days)
STARTED
|
4
|
3
|
4
|
3
|
|
Washout 2 (14 Days)
COMPLETED
|
4
|
3
|
4
|
3
|
|
Washout 2 (14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
4
|
3
|
4
|
4
|
|
Period 3
COMPLETED
|
4
|
3
|
4
|
4
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout 3 (14 Days)
STARTED
|
4
|
3
|
4
|
4
|
|
Washout 3 (14 Days)
COMPLETED
|
4
|
3
|
4
|
4
|
|
Washout 3 (14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 4
STARTED
|
4
|
3
|
4
|
4
|
|
Period 4
COMPLETED
|
4
|
3
|
4
|
4
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1: Placebo,10 mg LY3526318,100 mg LY3526318,30 mg LY3526318
Period 1: Participant received placebo orally.
Period 2: Participants received 10 milligrams (mg) LY3526318 orally.
Period 3: Participants received 100 mg LY3526318 orally.
Period 4: Participants received 30 mg LY3526318 orally.
|
Sequence 2: 10 mg LY3526318,30 mg LY3526318, Placebo,100 mg LY3526318
Period 1: Participant received 10 mg LY3526318 orally.
Period 2: Participants received 30 mg LY3526318 orally.
Period 3: Participants received Placebo orally.
Period 4: Participants received 100 mg LY3526318 orally.
|
Sequence 3: 30 mg LY3526318,100 mg LY3526318,10 mg LY3526318, Placebo
Period 1: Participant received 30 mg LY3526318 orally.
Period 2: Participants received 100 mg LY3526318 orally.
Period 3: Participants received 10 mg LY3526318 orally.
Period 4: Participants received Placebo orally.
|
Sequence 4: 100 mg LY3526318, Placebo, 30 mg LY3526318,10 mg LY3526318
Period 1: Participant received 100 mg LY3526318 orally.
Period 2: Participants received Placebo orally.
Period 3: Participants received 30 mg LY3526318 orally.
Period 4: Participants received 10 mg LY3526318 orally.
|
|---|---|---|---|---|
|
Period 1
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Washout 1(14 Days)
Positive Drug Screen
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of LY3526318 in Healthy Women
Baseline characteristics by cohort
| Measure |
All Participants
n=16 Participants
Sequence 1:
Period 1: Participant received placebo orally.
Period 2: Participants received 10 mg LY3526318 orally.
Period 3: Participants received 100 mg LY3526318 orally.
Period 4: Participants received 30 mg LY3526318 orally.
Sequence 2:
Period 1: Participant received 10 mg LY3526318 orally.
Period 2: Participants received 30 mg LY3526318 orally.
Period 3: Participants received Placebo orally.
Period 4: Participants received 100 mg LY3526318 orally.
Sequence 3:
Period 1: Participant received 30 mg LY3526318 orally.
Period 2: Participants received 100 mg LY3526318 orally.
Period 3: Participants received 10 mg LY3526318 orally.
Period 4: Participants received Placebo orally.
Sequence 4:
Period 1: Participant received 100 mg LY3526318 orally.
Period 2: Participants received Placebo orally.
Period 3: Participants received 30 mg LY3526318 orally.
Period 4: Participants received 10 mg LY3526318 orally.
|
|---|---|
|
Age, Continuous
|
29 years
STANDARD_DEVIATION 6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Belgium
|
16 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 hours post LY3526318 dose (pre-CA challenge), 3.3 hours post LY3526318 dose (post-CA challenge)Population: All participants who received LY3526318 or placebo at least once and had at least one reliable post-dose pharmacodynamic measurement.
CA-induced DBF was measured by laser doppler imaging (LDI). Least Squares (LS) mean was determined by analysis of variance (ANOVA) model with treatment, period, sequence, time and treatment\*time interaction as fixed factors and subject within sequence as a random factor.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participant received Placebo orally.
|
10 mg LY3526318
n=16 Participants
Participant received 10 mg LY3526318 orally.
|
30 mg LY3526318
n=15 Participants
Participant received 30 mg LY3526318 orally.
|
100 mg LY3526318
n=15 Participants
Participant received 100 mg LY3526318 orally.
|
|---|---|---|---|---|
|
Decrease in Cinnamaldehyde (CA)-Induced Dermal Blood Flow (DBF) Relative to Placebo Measured by Laser Doppler Imaging (LDI) at 3 Hours Post-dose (LDI)
Ring/CA Concentration (conc): Vehicle, Type: Region of Interest (ROI)
|
-9.46 Perfusion unit
Standard Error 6.45
|
-6.96 Perfusion unit
Standard Error 6.45
|
-14.82 Perfusion unit
Standard Error 6.45
|
-7.78 Perfusion unit
Standard Error 6.45
|
|
Decrease in Cinnamaldehyde (CA)-Induced Dermal Blood Flow (DBF) Relative to Placebo Measured by Laser Doppler Imaging (LDI) at 3 Hours Post-dose (LDI)
Ring/CA conc: Vehicle, Type: Entire Image
|
-14.22 Perfusion unit
Standard Error 3.28
|
-15.1 Perfusion unit
Standard Error 3.28
|
-12.34 Perfusion unit
Standard Error 3.28
|
-13.57 Perfusion unit
Standard Error 3.28
|
|
Decrease in Cinnamaldehyde (CA)-Induced Dermal Blood Flow (DBF) Relative to Placebo Measured by Laser Doppler Imaging (LDI) at 3 Hours Post-dose (LDI)
Ring/CA conc: 3%, Type: Region of Interest) ROI
|
811.66 Perfusion unit
Standard Error 98.22
|
757.83 Perfusion unit
Standard Error 98.22
|
771.15 Perfusion unit
Standard Error 98.22
|
758.66 Perfusion unit
Standard Error 98.22
|
|
Decrease in Cinnamaldehyde (CA)-Induced Dermal Blood Flow (DBF) Relative to Placebo Measured by Laser Doppler Imaging (LDI) at 3 Hours Post-dose (LDI)
Ring/CA conc: 3%, Type: Entire Image
|
213.82 Perfusion unit
Standard Error 37.75
|
177.17 Perfusion unit
Standard Error 37.75
|
191.32 Perfusion unit
Standard Error 37.75
|
179.95 Perfusion unit
Standard Error 37.75
|
|
Decrease in Cinnamaldehyde (CA)-Induced Dermal Blood Flow (DBF) Relative to Placebo Measured by Laser Doppler Imaging (LDI) at 3 Hours Post-dose (LDI)
Ring/CA conc: 10% , Type: Region of Interest (ROI)
|
1264.46 Perfusion unit
Standard Error 88.61
|
1233.80 Perfusion unit
Standard Error 88.61
|
1165.69 Perfusion unit
Standard Error 88.61
|
1049.57 Perfusion unit
Standard Error 88.61
|
|
Decrease in Cinnamaldehyde (CA)-Induced Dermal Blood Flow (DBF) Relative to Placebo Measured by Laser Doppler Imaging (LDI) at 3 Hours Post-dose (LDI)
Ring/CA conc: 10% , Type: Entire Image
|
610.17 Perfusion unit
Standard Error 65.79
|
606.28 Perfusion unit
Standard Error 65.79
|
419.15 Perfusion unit
Standard Error 65.79
|
357.93 Perfusion unit
Standard Error 65.79
|
SECONDARY outcome
Timeframe: 3 hours post LY3526318 dose (pre-CA challenge), 3.3 hours post LY3526318 dose (post-CA challenge)Population: All participants who received LY3526318 or placebo at least once and had at least one reliable post-dose pharmacodynamic measurement.
CA-induced DBF was measured by LSCI. LS mean was determined by ANOVA model with treatment, period, sequence, time and treatment\*time interaction as fixed factors and subject within sequence as a random factor.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participant received Placebo orally.
|
10 mg LY3526318
n=16 Participants
Participant received 10 mg LY3526318 orally.
|
30 mg LY3526318
n=15 Participants
Participant received 30 mg LY3526318 orally.
|
100 mg LY3526318
n=15 Participants
Participant received 100 mg LY3526318 orally.
|
|---|---|---|---|---|
|
Decrease in CA-induced Dermal Blood Flow (DBF) Relative to Placebo Measured by Laser Speckle Contrast Imaging (LSCI) at 3 Hours Post-dose (LSCI)
Ring/CA conc: Vehicle, Type: Region of Interest (ROI)
|
-18.60 Perfusion unit
Standard Error 3.49
|
-18.66 Perfusion unit
Standard Error 3.49
|
-19.19 Perfusion unit
Standard Error 3.49
|
-16.07 Perfusion unit
Standard Error 3.49
|
|
Decrease in CA-induced Dermal Blood Flow (DBF) Relative to Placebo Measured by Laser Speckle Contrast Imaging (LSCI) at 3 Hours Post-dose (LSCI)
Ring/CA conc: Vehicle, Type: Entire Image
|
-13.50 Perfusion unit
Standard Error 3.61
|
-14.79 Perfusion unit
Standard Error 3.61
|
-12.06 Perfusion unit
Standard Error 3.61
|
-11.66 Perfusion unit
Standard Error 3.61
|
|
Decrease in CA-induced Dermal Blood Flow (DBF) Relative to Placebo Measured by Laser Speckle Contrast Imaging (LSCI) at 3 Hours Post-dose (LSCI)
Ring/CA conc: 3%, Type: Region of Interest (ROI)
|
217.47 Perfusion unit
Standard Error 26.49
|
199.09 Perfusion unit
Standard Error 26.49
|
214.50 Perfusion unit
Standard Error 26.49
|
2017.36 Perfusion unit
Standard Error 26.49
|
|
Decrease in CA-induced Dermal Blood Flow (DBF) Relative to Placebo Measured by Laser Speckle Contrast Imaging (LSCI) at 3 Hours Post-dose (LSCI)
Ring/CA conc: 3%, Type: Entire Image
|
61.23 Perfusion unit
Standard Error 12.13
|
49.92 Perfusion unit
Standard Error 12.13
|
58.04 Perfusion unit
Standard Error 12.13
|
50.77 Perfusion unit
Standard Error 12.13
|
|
Decrease in CA-induced Dermal Blood Flow (DBF) Relative to Placebo Measured by Laser Speckle Contrast Imaging (LSCI) at 3 Hours Post-dose (LSCI)
Ring/CA conc: 10%, Type: Region of Interest (ROI)
|
306.68 Perfusion unit
Standard Error 16.98
|
313.96 Perfusion unit
Standard Error 16.98
|
285.98 Perfusion unit
Standard Error 16.98
|
271.90 Perfusion unit
Standard Error 16.98
|
|
Decrease in CA-induced Dermal Blood Flow (DBF) Relative to Placebo Measured by Laser Speckle Contrast Imaging (LSCI) at 3 Hours Post-dose (LSCI)
Ring/CA conc: 10%, Type: Entire Image
|
165.07 Perfusion unit
Standard Error 19.74
|
175.09 Perfusion unit
Standard Error 19.74
|
111.44 Perfusion unit
Standard Error 19.74
|
85.57 Perfusion unit
Standard Error 19.74
|
SECONDARY outcome
Timeframe: Predose, 3 hours and 24 hours after each LY3526318 dose (days 1 through 50)Population: All participants who received at least one dose of study drug and had evaluable PK data.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3526318
Outcome measures
| Measure |
Placebo
n=16 Participants
Participant received Placebo orally.
|
10 mg LY3526318
n=15 Participants
Participant received 10 mg LY3526318 orally.
|
30 mg LY3526318
n=15 Participants
Participant received 30 mg LY3526318 orally.
|
100 mg LY3526318
Participant received 100 mg LY3526318 orally.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3526318
|
NA nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Measurement results were below Lower Limit of Quantification.
|
NA nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Measurement results were below Lower Limit of Quantification.
|
NA nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Measurement results were below Lower Limit of Quantification.
|
—
|
SECONDARY outcome
Timeframe: Predose, 3 hours and 24 hours after each LY3526318 dose (days 1 through 50)Population: All participants who received at least one dose of study drug and had evaluable PK data.
PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
Outcome measures
| Measure |
Placebo
n=16 Participants
Participant received Placebo orally.
|
10 mg LY3526318
n=15 Participants
Participant received 10 mg LY3526318 orally.
|
30 mg LY3526318
n=15 Participants
Participant received 30 mg LY3526318 orally.
|
100 mg LY3526318
Participant received 100 mg LY3526318 orally.
|
|---|---|---|---|---|
|
PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
|
NA micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation NA
Measurement results were below Lower Limit of Quantification.
|
NA micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation NA
Measurement results were below Lower Limit of Quantification.
|
NA micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation NA
Measurement results were below Lower Limit of Quantification.
|
—
|
SECONDARY outcome
Timeframe: 3 hours and 24 hours post dosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Plasma Concentrations of LY3526318 at 3 and 24 Hours
Outcome measures
| Measure |
Placebo
n=16 Participants
Participant received Placebo orally.
|
10 mg LY3526318
n=15 Participants
Participant received 10 mg LY3526318 orally.
|
30 mg LY3526318
n=15 Participants
Participant received 30 mg LY3526318 orally.
|
100 mg LY3526318
Participant received 100 mg LY3526318 orally.
|
|---|---|---|---|---|
|
Plasma Concentrations of LY3526318 at 3 and 24 Hours
3 Hours
|
231.4 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 71.4
|
627.1 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 92.2
|
3669.6 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 55.3
|
—
|
|
Plasma Concentrations of LY3526318 at 3 and 24 Hours
24 Hours
|
64.9 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 70.5
|
138.0 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 123.8
|
854.0 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 84.4
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
LY3526318 10 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
LY3526318 30 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
LY3526318 100 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=14 participants at risk
Participants received Placebo orally.
|
LY3526318 10 mg
n=16 participants at risk
Participants received 10 mg LY3526318 orally.
|
LY3526318 30 mg
n=15 participants at risk
Participants received 30 mg LY3526318 orally.
|
LY3526318 100 mg
n=15 participants at risk
Participants received 100 mg LY3526318 orally.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/14 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
1/14 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
6.2%
1/16 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Pyuria
|
14.3%
2/14 • Number of events 2 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/14 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/14 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
6.2%
1/16 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
7.1%
1/14 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound
|
7.1%
1/14 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
7.1%
1/14 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/14 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
6.2%
1/16 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/14 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.1%
1/14 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
35.7%
5/14 • Number of events 6 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
12.5%
2/16 • Number of events 3 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
13.3%
2/15 • Number of events 2 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
13.3%
2/15 • Number of events 2 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
7.1%
1/14 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
7.1%
1/14 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Leukocyturia
|
7.1%
1/14 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
12.5%
2/16 • Number of events 2 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
14.3%
2/14 • Number of events 2 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
18.8%
3/16 • Number of events 3 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
13.3%
2/15 • Number of events 2 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
6.7%
1/15 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Diastolic hypotension
|
0.00%
0/14 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
6.2%
1/16 • Number of events 1 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All participants who received at least one dose of study drug.
|
0.00%
0/15 • Baseline Up To 50 Days
All 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