Trial Outcomes & Findings for A Study of Selpercatinib (LY3527723) in Healthy Participants (NCT NCT05338515)
NCT ID: NCT05338515
Last Updated: 2025-05-18
Results Overview
Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Baseline up to Day 8
Results posted on
2025-05-18
Participant Flow
Participant milestones
| Measure |
320 Milligram (mg) Selpercatinib
Participants received a single oral dose of 320 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
640 mg Selpercatinib
Participants received a single oral dose of 640 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
720 mg Selpercatinib
Participants received a single oral dose of 720 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
|
Overall Study
Received at Least One Dose of Study Drug
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Selpercatinib (LY3527723) in Healthy Participants
Baseline characteristics by cohort
| Measure |
320 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 320 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
640 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 640 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
720 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 720 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.8 years
STANDARD_DEVIATION 7.19 • n=93 Participants
|
36.7 years
STANDARD_DEVIATION 10.69 • n=4 Participants
|
39.3 years
STANDARD_DEVIATION 9.99 • n=27 Participants
|
37.9 years
STANDARD_DEVIATION 8.91 • n=483 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 8Population: All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.
Outcome measures
| Measure |
320 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 320 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
640 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 640 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
720 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 720 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: AUC0-t is calculated using the linear trapezoidal with linear interpolation method.
Outcome measures
| Measure |
320 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 320 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
640 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 640 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
720 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 720 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib
|
35900 nanogram*hour per milliliter (ng*h/ mL)
Geometric Coefficient of Variation 59.7
|
50460 nanogram*hour per milliliter (ng*h/ mL)
Geometric Coefficient of Variation 46.5
|
60960 nanogram*hour per milliliter (ng*h/ mL)
Geometric Coefficient of Variation 50.7
|
SECONDARY outcome
Timeframe: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: AUC0-24 was calculated using the linear trapezoidal with linear interpolation method.
Outcome measures
| Measure |
320 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 320 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
640 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 640 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
720 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 720 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
|---|---|---|---|
|
PK: Area Under the Concentration-time Curve, From Time 0 to Hour 24 (AUC0-24) of Selpercatinib
|
21280 ng*h/ mL
Geometric Coefficient of Variation 79.8
|
30680 ng*h/ mL
Geometric Coefficient of Variation 50.5
|
36450 ng*h/ mL
Geometric Coefficient of Variation 58.3
|
SECONDARY outcome
Timeframe: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: AUC0-inf was calculated as AUC0-inf = AUC0-t + (Clast/Kel) where Clast is the last observed/measured concentration and Kel is the apparent terminal elimination rate constant, which represents the fraction of drug eliminated per unit time.
Outcome measures
| Measure |
320 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 320 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
640 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 640 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
720 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 720 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
|---|---|---|---|
|
PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib
|
36080 nanogram*hour per milliliter (ng*h/ mL)
Geometric Coefficient of Variation 59.7
|
50770 nanogram*hour per milliliter (ng*h/ mL)
Geometric Coefficient of Variation 46.7
|
61380 nanogram*hour per milliliter (ng*h/ mL)
Geometric Coefficient of Variation 50.7
|
SECONDARY outcome
Timeframe: Predose -168 hours post dosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: Percent of AUC0-inf extrapolated was calculated as (1-AUC0-t/AUC0-inf) \*100.
Outcome measures
| Measure |
320 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 320 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
640 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 640 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
720 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 720 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
|---|---|---|---|
|
PK: Percent of AUC0-inf Extrapolated (AUC%Extrap) of Selpercatinib
|
0.5159 percentage
Standard Deviation 0.44688
|
0.6238 percentage
Standard Deviation 0.29008
|
0.6869 percentage
Standard Deviation 0.29427
|
SECONDARY outcome
Timeframe: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: CL/F was calculated as Dose/(AUC0-inf).
Outcome measures
| Measure |
320 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 320 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
640 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 640 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
720 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 720 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
|---|---|---|---|
|
PK: Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Selpercatinib
|
10.16 Liters per Hour (L/h)
Standard Deviation 6.3442
|
13.62 Liters per Hour (L/h)
Standard Deviation 5.5060
|
12.79 Liters per Hour (L/h)
Standard Deviation 5.2828
|
SECONDARY outcome
Timeframe: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: Cmax was taken directly from bioanalytical data.
Outcome measures
| Measure |
320 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 320 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
640 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 640 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
720 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 720 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
|---|---|---|---|
|
PK: Maximum Observed Concentration (Cmax) of Selpercatinib
|
2282 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 88.6
|
3316 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 56.3
|
3745 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 55.2
|
SECONDARY outcome
Timeframe: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: Tmax was time to reach Cmax. If the maximum value occurs at more than one time point, Tmax is defined as the first time point with this value taken from clinical database as the difference in the time of administration and the time of the blood draw which is associated with the Cmax.
Outcome measures
| Measure |
320 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 320 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
640 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 640 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
720 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 720 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
|---|---|---|---|
|
PK: Time to Reach Cmax (Tmax) of Selpercatinib
|
2.001 hour
Interval 1.5 to 3.0
|
1.999 hour
Interval 1.03 to 2.51
|
2.753 hour
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: Apparent terminal elimination rate constant; represents the fraction of drug eliminated per unit time calculated by linear least squares regression analysis using the maximum number of points in the terminal log linear phase (e.g., three or more non zero plasma concentrations).
Outcome measures
| Measure |
320 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 320 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
640 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 640 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
720 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 720 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
|---|---|---|---|
|
PK: Apparent First-order Terminal Elimination Rate Constant (Kel) of Selpercatinib
|
0.03122 1/hour (1/h)
Standard Deviation 0.0094408
|
0.02607 1/hour (1/h)
Standard Deviation 0.0054791
|
0.02562 1/hour (1/h)
Standard Deviation 0.0040999
|
SECONDARY outcome
Timeframe: Predose (within 30 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: Vz/F calculated as Dose/(AUC0-inf x Kel).
Outcome measures
| Measure |
320 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 320 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
640 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 640 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
720 mg Selpercatinib
n=6 Participants
Participants received a single oral dose of 720 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
|---|---|---|---|
|
PK: Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Selpercatinib
|
328.7 Liter
Standard Deviation 156.37
|
526.3 Liter
Standard Deviation 219.99
|
487.0 Liter
Standard Deviation 158.59
|
Adverse Events
320 mg Selpercatinib
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
640 mg Selpercatinib
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
720 mg Selpercatinib
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
320 mg Selpercatinib
n=6 participants at risk
Participants received a single oral dose of 320 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
640 mg Selpercatinib
n=6 participants at risk
Participants received a single oral dose of 640 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
720 mg Selpercatinib
n=6 participants at risk
Participants received a single oral dose of 720 mg selpercatinib on Day 1, preceded by an overnight fast of at least 10 hours, followed by a fast from food (not including water) for at least 4 hours post dose.
|
|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Ulcer
|
16.7%
1/6 • Number of events 1 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to Day 8
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 Day 8
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Burning sensation
|
16.7%
1/6 • Number of events 1 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/6 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
1/6 • Number of events 1 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/6 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline up to Day 8
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline up to Day 8
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