Trial Outcomes & Findings for A Study of Imlunestrant (LY3484356) in Female Healthy Participants (NCT NCT05444556)
NCT ID: NCT05444556
Last Updated: 2025-12-12
Results Overview
PK: AUC\[0-∞\] of Digoxin
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
113 participants
Primary outcome timeframe
Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dose
Results posted on
2025-12-12
Participant Flow
Participant milestones
| Measure |
Imlunestrant + Repaglinide (Cohort 1)
Participants received:
Day 1: A single oral dose of 0.5 mg repaglinide administered alone.
Day 3: A single oral dose of 800 mg imlunestrant, followed approximately 2 hours later by 0.5 mg repaglinide, both administered orally.
|
Imlunestrant + Omeprazole & Dextromethorphan (Cohort 2)
Participants received:
Day 1: A single oral dose of 20 mg omeprazole and 30 mg dextromethorphan, administered in the morning.
Day 3: A single oral dose of 800 mg imlunestrant, followed immediately by 20 mg omeprazole and 30 mg dextromethorphan, all administered orally.
|
Imlunestrant + Quinidine (Cohort 3)
Participants received:
Day 1: A single oral dose of 400 mg imlunestrant, administered in the morning.
Days 15 to 17 and 19 to 24: Twice-daily oral doses of 200 mg quinidine, administered alone.
Day 18: A single oral dose of 400 mg imlunestrant administered in combination with 200 mg quinidine (quinidine was dosed twice on this day as part of the regular regimen).
|
Imlunestrant + Rosuvastatin & Digoxin (Cohort 4)
Participants received:
Day 1: A single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin, administered in the morning.
Day 10: A single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
32
|
27
|
|
Overall Study
Received at Least One Dose of Study Drug
|
27
|
27
|
32
|
27
|
|
Overall Study
COMPLETED
|
27
|
27
|
30
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
Imlunestrant + Repaglinide (Cohort 1)
Participants received:
Day 1: A single oral dose of 0.5 mg repaglinide administered alone.
Day 3: A single oral dose of 800 mg imlunestrant, followed approximately 2 hours later by 0.5 mg repaglinide, both administered orally.
|
Imlunestrant + Omeprazole & Dextromethorphan (Cohort 2)
Participants received:
Day 1: A single oral dose of 20 mg omeprazole and 30 mg dextromethorphan, administered in the morning.
Day 3: A single oral dose of 800 mg imlunestrant, followed immediately by 20 mg omeprazole and 30 mg dextromethorphan, all administered orally.
|
Imlunestrant + Quinidine (Cohort 3)
Participants received:
Day 1: A single oral dose of 400 mg imlunestrant, administered in the morning.
Days 15 to 17 and 19 to 24: Twice-daily oral doses of 200 mg quinidine, administered alone.
Day 18: A single oral dose of 400 mg imlunestrant administered in combination with 200 mg quinidine (quinidine was dosed twice on this day as part of the regular regimen).
|
Imlunestrant + Rosuvastatin & Digoxin (Cohort 4)
Participants received:
Day 1: A single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin, administered in the morning.
Day 10: A single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
1
|
Baseline Characteristics
A Study of Imlunestrant (LY3484356) in Female Healthy Participants
Baseline characteristics by cohort
| Measure |
Imlunestrant + Repaglinide (Cohort 1)
n=27 Participants
Participants received:
Day 1: A single oral dose of 0.5 mg repaglinide administered alone.
Day 3: A single oral dose of 800 mg imlunestrant, followed approximately 2 hours later by 0.5 mg repaglinide, both administered orally.
|
Imlunestrant + Omeprazole & Dextromethorphan (Cohort 2)
n=27 Participants
Participants received:
Day 1: A single oral dose of 20 mg omeprazole and 30 mg dextromethorphan, administered in the morning.
Day 3: A single oral dose of 800 mg imlunestrant, followed immediately by 20 mg omeprazole and 30 mg dextromethorphan, all administered orally.
|
Imlunestrant + Quinidine (Cohort 3)
n=32 Participants
Participants received:
Day 1: A single oral dose of 400 mg imlunestrant, administered in the morning.
Days 15 to 17 and 19 to 24: Twice-daily oral doses of 200 mg quinidine, administered alone.
Day 18: A single oral dose of 400 mg imlunestrant administered in combination with 200 mg quinidine (quinidine was dosed twice on this day as part of the regular regimen).
|
Imlunestrant + Rosuvastatin & Digoxin (Cohort 4)
n=27 Participants
Participants received:
Day 1: A single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin, administered in the morning.
Day 10: A single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally.
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53.3 years
STANDARD_DEVIATION 8.2 • n=9 Participants
|
52.6 years
STANDARD_DEVIATION 8.2 • n=6 Participants
|
55.9 years
STANDARD_DEVIATION 6.3 • n=9 Participants
|
54.1 years
STANDARD_DEVIATION 7.1 • n=78 Participants
|
54.1 years
STANDARD_DEVIATION 7.4 • n=16 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=9 Participants
|
27 Participants
n=6 Participants
|
32 Participants
n=9 Participants
|
27 Participants
n=78 Participants
|
113 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=9 Participants
|
19 Participants
n=6 Participants
|
23 Participants
n=9 Participants
|
14 Participants
n=78 Participants
|
78 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=9 Participants
|
8 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
13 Participants
n=78 Participants
|
35 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=78 Participants
|
2 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
7 Participants
n=78 Participants
|
19 Participants
n=16 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=9 Participants
|
21 Participants
n=6 Participants
|
27 Participants
n=9 Participants
|
19 Participants
n=78 Participants
|
90 Participants
n=16 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=78 Participants
|
2 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
|
Region of Enrollment
United States
|
27 Participants
n=9 Participants
|
27 Participants
n=6 Participants
|
32 Participants
n=9 Participants
|
27 Participants
n=78 Participants
|
113 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dosePopulation: All participants in Cohort 1 who received at least one dose of repaglinide and had evaluable PK data for this outcome.
PK: AUC\[0-∞\] of Repaglinide
Outcome measures
| Measure |
10 mg Rosuvastatin + 0.25 mg Digoxin
n=24 Participants
Participants received a single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin on Day 1.
|
400 mg Imlunestrant + 10 mg Rosuvastatin + 0.25 mg Digoxin
n=23 Participants
Participants received a single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally on Day 10.
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Repaglinide (Cohort 1)
|
13.0 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 31
|
13.6 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 31
|
PRIMARY outcome
Timeframe: Day 1 and Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dosePopulation: All participants in Cohort 1 who received at least one dose of repaglinide and had evaluable PK data for this outcome.
PK: Cmax of Repaglinide
Outcome measures
| Measure |
10 mg Rosuvastatin + 0.25 mg Digoxin
n=27 Participants
Participants received a single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin on Day 1.
|
400 mg Imlunestrant + 10 mg Rosuvastatin + 0.25 mg Digoxin
n=27 Participants
Participants received a single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally on Day 10.
|
|---|---|---|
|
PK: Maximum Observed Concentration (Cmax) of Repaglinide (Cohort 1)
|
10.5 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 38
|
9.84 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 44
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdosePopulation: All participants in Cohort 2, who received at least one dose of omeprazole and had evaluable PK data for this outcome.
PK: AUC\[0-∞\] of Omeprazole
Outcome measures
| Measure |
10 mg Rosuvastatin + 0.25 mg Digoxin
n=21 Participants
Participants received a single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin on Day 1.
|
400 mg Imlunestrant + 10 mg Rosuvastatin + 0.25 mg Digoxin
n=26 Participants
Participants received a single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally on Day 10.
|
|---|---|---|
|
PK: AUC[0-∞] of Omeprazole (Cohort 2)
|
703 ng*hr/mL
Geometric Coefficient of Variation 77
|
825 ng*hr/mL
Geometric Coefficient of Variation 74
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdosePopulation: All participants in Cohort 2, who received at least one dose of omeprazole and had evaluable PK data for this outcome.
PK: Cmax of Omeprazole
Outcome measures
| Measure |
10 mg Rosuvastatin + 0.25 mg Digoxin
n=27 Participants
Participants received a single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin on Day 1.
|
400 mg Imlunestrant + 10 mg Rosuvastatin + 0.25 mg Digoxin
n=27 Participants
Participants received a single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally on Day 10.
|
|---|---|---|
|
PK: Cmax of Omeprazole (Cohort 2)
|
316 ng/mL
Geometric Coefficient of Variation 73
|
405 ng/mL
Geometric Coefficient of Variation 57
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdosePopulation: All participants in Cohort 2, who received at least one dose of omeprazole and had evaluable PK data for this outcome.
5-hydroxyomeprazole is a major metabolite of omeprazole.
Outcome measures
| Measure |
10 mg Rosuvastatin + 0.25 mg Digoxin
n=24 Participants
Participants received a single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin on Day 1.
|
400 mg Imlunestrant + 10 mg Rosuvastatin + 0.25 mg Digoxin
n=26 Participants
Participants received a single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally on Day 10.
|
|---|---|---|
|
PK: AUC[0-∞] of Omeprazole Metabolite: 5-hydroxyomeprazole (Cohort 2)
|
571 ng*hr/mL
Geometric Coefficient of Variation 26
|
592 ng*hr/mL
Geometric Coefficient of Variation 19
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdosePopulation: All participants in Cohort 2, who received at least one dose of omeprazole and had evaluable PK data for this outcome.
5-hydroxyomeprazole is a major metabolite of omeprazole.
Outcome measures
| Measure |
10 mg Rosuvastatin + 0.25 mg Digoxin
n=27 Participants
Participants received a single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin on Day 1.
|
400 mg Imlunestrant + 10 mg Rosuvastatin + 0.25 mg Digoxin
n=27 Participants
Participants received a single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally on Day 10.
|
|---|---|---|
|
PK: Cmax of Omeprazole Metabolite: 5-hydroxyomeprazole (Cohort 2)
|
200 ng/mL
Geometric Coefficient of Variation 52
|
230 ng/mL
Geometric Coefficient of Variation 42
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdosePopulation: All Cohort 2 participants who received at least one dose of dextromethorphan and had evaluable PK data for this outcome.
PK: AUC\[0-∞\] of Dextromethorphan
Outcome measures
| Measure |
10 mg Rosuvastatin + 0.25 mg Digoxin
n=25 Participants
Participants received a single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin on Day 1.
|
400 mg Imlunestrant + 10 mg Rosuvastatin + 0.25 mg Digoxin
n=12 Participants
Participants received a single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally on Day 10.
|
|---|---|---|
|
PK: AUC[0-∞] of Dextromethorphan (Cohort 2)
|
14.7 ng*hr/mL
Geometric Coefficient of Variation 127
|
16.1 ng*hr/mL
Geometric Coefficient of Variation 111
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdosePopulation: All Cohort 2 participants who received at least one dose of dextromethorphan and had evaluable PK data for this outcome.
PK: Cmax of Dextromethorphan
Outcome measures
| Measure |
10 mg Rosuvastatin + 0.25 mg Digoxin
n=26 Participants
Participants received a single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin on Day 1.
|
400 mg Imlunestrant + 10 mg Rosuvastatin + 0.25 mg Digoxin
n=12 Participants
Participants received a single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally on Day 10.
|
|---|---|---|
|
PK: Cmax of Dextromethorphan (Cohort 2)
|
0.864 ng/mL
Geometric Coefficient of Variation 124
|
1.13 ng/mL
Geometric Coefficient of Variation 124
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdosePopulation: All Cohort 2 participants who received at least one dose of dextromethorphan and had evaluable PK data for this outcome.
Dextrorphan is a major metabolite of Dextromethorphan.
Outcome measures
| Measure |
10 mg Rosuvastatin + 0.25 mg Digoxin
n=26 Participants
Participants received a single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin on Day 1.
|
400 mg Imlunestrant + 10 mg Rosuvastatin + 0.25 mg Digoxin
n=26 Participants
Participants received a single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally on Day 10.
|
|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Tlast (AUC[0-tlast]) of Dextromethorphan Metabolite: Dextrorphan (Cohort 2)
|
11.8 ng*hr/mL
Geometric Coefficient of Variation 62
|
11.9 ng*hr/mL
Geometric Coefficient of Variation 75
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdosePopulation: All Cohort 2 participants who received at least one dose of dextromethorphan and had evaluable PK data for this outcome.
Dextrorphan is a major metabolite of Dextromethorphan.
Outcome measures
| Measure |
10 mg Rosuvastatin + 0.25 mg Digoxin
n=26 Participants
Participants received a single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin on Day 1.
|
400 mg Imlunestrant + 10 mg Rosuvastatin + 0.25 mg Digoxin
n=26 Participants
Participants received a single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally on Day 10.
|
|---|---|---|
|
PK: Cmax of Dextromethorphan Metabolite: Dextrorphan (Cohort 2)
|
1.79 ng/mL
Geometric Coefficient of Variation 50
|
1.97 ng/mL
Geometric Coefficient of Variation 56
|
PRIMARY outcome
Timeframe: Day 1 and Day 18: Predose, 1, 2, 3, 4, 5, 6 ,8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 h post dosePopulation: All cohort 3 participants who received at least one dose of imlunestrant and had evaluable PK data for this outcome.
PK: AUC\[0-∞\] of Imlunestrant
Outcome measures
| Measure |
10 mg Rosuvastatin + 0.25 mg Digoxin
n=30 Participants
Participants received a single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin on Day 1.
|
400 mg Imlunestrant + 10 mg Rosuvastatin + 0.25 mg Digoxin
n=31 Participants
Participants received a single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally on Day 10.
|
|---|---|---|
|
PK: AUC[0-∞] of Imlunestrant (Cohort 3)
|
1970 ng*hr/mL
Geometric Coefficient of Variation 66
|
1870 ng*hr/mL
Geometric Coefficient of Variation 87
|
PRIMARY outcome
Timeframe: Day 1 and Day 18: Predose, 1, 2, 3, 4, 5, 6 ,8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 h post dosePopulation: All cohort 3 participants who received at least one dose of imlunestrant and had evaluable PK data for this outcome.
PK: Cmax of Imlunestrant
Outcome measures
| Measure |
10 mg Rosuvastatin + 0.25 mg Digoxin
n=32 Participants
Participants received a single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin on Day 1.
|
400 mg Imlunestrant + 10 mg Rosuvastatin + 0.25 mg Digoxin
n=31 Participants
Participants received a single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally on Day 10.
|
|---|---|---|
|
PK: Cmax of Imlunestrant (Cohort 3)
|
61.0 ng/mL
Geometric Coefficient of Variation 82
|
54.3 ng/mL
Geometric Coefficient of Variation 81
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dosePopulation: All cohort 4 participants who received at least one dose of rosuvastatin and had evaluable PK data for this outcome.
PK: AUC\[0-∞\] of Rosuvastatin
Outcome measures
| Measure |
10 mg Rosuvastatin + 0.25 mg Digoxin
n=14 Participants
Participants received a single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin on Day 1.
|
400 mg Imlunestrant + 10 mg Rosuvastatin + 0.25 mg Digoxin
n=20 Participants
Participants received a single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally on Day 10.
|
|---|---|---|
|
PK: AUC[0-∞] of Rosuvastatin (Cohort 4)
|
29.0 ng*hr/mL
Geometric Coefficient of Variation 47
|
44.9 ng*hr/mL
Geometric Coefficient of Variation 51
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dosePopulation: All cohort 4 participants who received at least one dose of rosuvastatin and had evaluable PK data for this outcome.
PK: Cmax of Rosuvastatin
Outcome measures
| Measure |
10 mg Rosuvastatin + 0.25 mg Digoxin
n=26 Participants
Participants received a single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin on Day 1.
|
400 mg Imlunestrant + 10 mg Rosuvastatin + 0.25 mg Digoxin
n=25 Participants
Participants received a single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally on Day 10.
|
|---|---|---|
|
PK: Cmax of Rosuvastatin (Cohort 4)
|
2.99 ng/mL
Geometric Coefficient of Variation 53
|
5.08 ng/mL
Geometric Coefficient of Variation 59
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dosePopulation: All cohort 4 participants who received at least one dose of digoxin and had evaluable PK data for this outcome.
PK: AUC\[0-∞\] of Digoxin
Outcome measures
| Measure |
10 mg Rosuvastatin + 0.25 mg Digoxin
n=11 Participants
Participants received a single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin on Day 1.
|
400 mg Imlunestrant + 10 mg Rosuvastatin + 0.25 mg Digoxin
n=18 Participants
Participants received a single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally on Day 10.
|
|---|---|---|
|
PK: AUC[0-∞] of Digoxin (Cohort 4)
|
20.2 ng*hr/mL
Geometric Coefficient of Variation 23
|
28.0 ng*hr/mL
Geometric Coefficient of Variation 19
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dosePopulation: All cohort 4 participants who received at least one dose of digoxin and had evaluable PK data for this outcome.
PK: Cmax of Digoxin
Outcome measures
| Measure |
10 mg Rosuvastatin + 0.25 mg Digoxin
n=25 Participants
Participants received a single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin on Day 1.
|
400 mg Imlunestrant + 10 mg Rosuvastatin + 0.25 mg Digoxin
n=25 Participants
Participants received a single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally on Day 10.
|
|---|---|---|
|
PK: Cmax of Digoxin (Cohort 4)
|
1.17 ng/mL
Geometric Coefficient of Variation 39
|
1.88 ng/mL
Geometric Coefficient of Variation 38
|
Adverse Events
0.5 mg Repaglinide: Cohort 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
800 mg Imlunestrant + 0.5 mg Repaglinide: Cohort 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
20 mg Omeprazole + 30 mg Dextromethorphan: Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
800 mg Imlunestrant + 20 mg Omeprazole + 30 mg Dextromethorphan: Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
400 mg Imlunestrant (Day 1): Cohort 3
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
200 mg Quinidine BID (Days 15 to 17): Cohort 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
400 mg Imlunestrant + 200 mg Quinidine BID (Day 18): Cohort 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
200 mg Quinidine BID (Days 19 to 24): Cohort 3
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
10 mg Rosuvastatin + 0.25 mg Digoxin: Cohort 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
400 mg Imlunestrant + 10 mg Rosuvastatin + 0.25 mg Digoxin: Cohort 4
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0.5 mg Repaglinide: Cohort 1
n=27 participants at risk
Participants received a single oral dose of 0.5 mg repaglinide administered alone on Day 1.
|
800 mg Imlunestrant + 0.5 mg Repaglinide: Cohort 1
n=27 participants at risk
Participants received a single oral dose of 800 mg imlunestrant, followed approximately 2 hours later by 0.5 mg repaglinide, both administered orally on Day 3.
|
20 mg Omeprazole + 30 mg Dextromethorphan: Cohort 2
n=27 participants at risk
Participants received a single oral dose of 20 mg omeprazole and 30 mg dextromethorphan, administered in the morning on Day 1.
|
800 mg Imlunestrant + 20 mg Omeprazole + 30 mg Dextromethorphan: Cohort 2
n=27 participants at risk
Participants received a single oral dose of 800 mg imlunestrant, followed immediately by 20 mg omeprazole and 30 mg dextromethorphan, all administered orally on Day 3.
|
400 mg Imlunestrant (Day 1): Cohort 3
n=32 participants at risk
Participants received a single oral dose of 400 mg imlunestrant administered alone on Day 1.
|
200 mg Quinidine BID (Days 15 to 17): Cohort 3
n=32 participants at risk
Participants received twice-daily oral doses of 200 mg quinidine, administered alone from days 15 to 17.
|
400 mg Imlunestrant + 200 mg Quinidine BID (Day 18): Cohort 3
n=31 participants at risk
Participants received a single oral dose of 400 mg imlunestrant administered in combination with 200 mg quinidine (quinidine was dosed twice on this day as part of the regular regimen) on day 18.
|
200 mg Quinidine BID (Days 19 to 24): Cohort 3
n=31 participants at risk
Participants received BID oral doses of 200 mg quinidine, administered alone from Days 19 to 24.
|
10 mg Rosuvastatin + 0.25 mg Digoxin: Cohort 4
n=27 participants at risk
Participants received a single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin on Day 1.
|
400 mg Imlunestrant + 10 mg Rosuvastatin + 0.25 mg Digoxin: Cohort 4
n=26 participants at risk
Participants received a single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally on Day 10.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/27 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/27 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/27 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
3.7%
1/27 • Number of events 1 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
9.4%
3/32 • Number of events 3 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/32 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/31 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/31 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/27 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/26 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/27 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/27 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/27 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
7.4%
2/27 • Number of events 2 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/32 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
3.1%
1/32 • Number of events 1 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/31 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
6.5%
2/31 • Number of events 2 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/27 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/26 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
|
Gastrointestinal disorders
Nausea
|
3.7%
1/27 • Number of events 1 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/27 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/27 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/27 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/32 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
6.2%
2/32 • Number of events 2 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/31 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/31 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/27 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/26 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/27 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/27 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/27 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/27 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
6.2%
2/32 • Number of events 2 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/32 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/31 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/31 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/27 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/26 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/27 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/27 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/27 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/27 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
6.2%
2/32 • Number of events 2 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/32 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/31 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/31 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/27 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/26 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
|
Nervous system disorders
Headache
|
3.7%
1/27 • Number of events 1 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/27 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
11.1%
3/27 • Number of events 3 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
3.7%
1/27 • Number of events 1 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
12.5%
4/32 • Number of events 4 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
3.1%
1/32 • Number of events 1 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/31 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
6.5%
2/31 • Number of events 2 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
0.00%
0/27 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
3.8%
1/26 • Number of events 1 • Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60