Trial Outcomes & Findings for A Multiple-Dose Study of LY3493269 in Healthy Participants (NCT NCT05794243)
NCT ID: NCT05794243
Last Updated: 2025-01-14
Results Overview
PK: AUC (0-∞) of LY3493269
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
42 participants
Primary outcome timeframe
Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48, 72,120, 288, 624 and 960 hours (h) post-dose
Results posted on
2025-01-14
Participant Flow
The study was planned to be conducted in two parts (Part A and Part B) - * After the completion of Part A, following a preplanned review of the safety and pharmacokinetic data from Part A, it was determined that sufficient data had been obtained. Hence, the decision was made not to proceed with Part B, and the study was terminated early. * Only Part A results data are reported below.
Participant milestones
| Measure |
Part A: 4 mg LY3493269 Test Capsule 1 + 280 mg C10 (Fasted)
* Participants were administered oral doses of 4 milligram (mg) LY3493269 test capsule formulation 1, co-administered with 280 mg of sodium caprate (C10).
* This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
|
Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted)
* Participants were administered oral doses of 4 mg LY3493269 test capsule formulation 2, co-administered with 280 mg of C10.
* This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
|
Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted)
* Participants were administered oral doses of 4 mg LY3493269 reference tablet formulation, co-administered with 300 mg of salcaprozate sodium (SNAC).
* This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
15
|
15
|
|
Overall Study
Received at Least One Dose of Study Drug
|
11
|
15
|
14
|
|
Overall Study
COMPLETED
|
11
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
2
|
Reasons for withdrawal
| Measure |
Part A: 4 mg LY3493269 Test Capsule 1 + 280 mg C10 (Fasted)
* Participants were administered oral doses of 4 milligram (mg) LY3493269 test capsule formulation 1, co-administered with 280 mg of sodium caprate (C10).
* This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
|
Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted)
* Participants were administered oral doses of 4 mg LY3493269 test capsule formulation 2, co-administered with 280 mg of C10.
* This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
|
Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted)
* Participants were administered oral doses of 4 mg LY3493269 reference tablet formulation, co-administered with 300 mg of salcaprozate sodium (SNAC).
* This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
3
|
1
|
Baseline Characteristics
A Multiple-Dose Study of LY3493269 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part A: 4 mg LY3493269 Test Capsule 1 + 280 mg C10 (Fasted)
n=11 Participants
* Participants were administered oral doses of 4 mg LY3493269 test capsule formulation 1, co-administered with 280 mg of C10.
* This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
|
Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted)
n=15 Participants
* Participants were administered oral doses of 4 mg LY3493269 test capsule formulation 2, co-administered with 280 mg of C10.
* This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
|
Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted)
n=14 Participants
* Participants were administered oral doses of 4 mg LY3493269 reference tablet formulation, co-administered with 300 mg of SNAC.
* This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.9 years
STANDARD_DEVIATION 11.8 • n=99 Participants
|
42.8 years
STANDARD_DEVIATION 10.4 • n=107 Participants
|
39.4 years
STANDARD_DEVIATION 10.3 • n=206 Participants
|
41.6 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
38 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
39 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
Singapore
|
11 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48, 72,120, 288, 624 and 960 hours (h) post-dosePopulation: All enrolled participants who received at least one dose of LY3493269 and had at least one evaluable PK data.
PK: AUC (0-∞) of LY3493269
Outcome measures
| Measure |
Part A: 4 mg LY3493269 Test Capsule 1 + 280 mg C10 (Fasted)
n=11 Participants
* Participants were administered oral doses of 4 mg LY3493269 test capsule formulation 1, co-administered with 280 mg of C10.
* This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
|
Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted)
n=15 Participants
* Participants were administered oral doses of 4 mg LY3493269 test capsule formulation 2, co-administered with 280 mg of C10.
* This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
|
Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted)
n=14 Participants
* Participants were administered oral doses of 4 mg LY3493269 reference tablet formulation, co-administered with 300 mg of SNAC.
* This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
|
|---|---|---|---|
|
Part A: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3493269
|
1590 nanograms*hours per milliliter(ng*h/mL)
Geometric Coefficient of Variation 100
|
4880 nanograms*hours per milliliter(ng*h/mL)
Geometric Coefficient of Variation 58
|
12200 nanograms*hours per milliliter(ng*h/mL)
Geometric Coefficient of Variation 112
|
PRIMARY outcome
Timeframe: Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 14 and 24 hours (h) post-dosePopulation: All enrolled participants who received at least one dose of LY3493269 and had at least one evaluable PK data.
PK: AUCτ of LY3493269
Outcome measures
| Measure |
Part A: 4 mg LY3493269 Test Capsule 1 + 280 mg C10 (Fasted)
n=11 Participants
* Participants were administered oral doses of 4 mg LY3493269 test capsule formulation 1, co-administered with 280 mg of C10.
* This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
|
Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted)
n=15 Participants
* Participants were administered oral doses of 4 mg LY3493269 test capsule formulation 2, co-administered with 280 mg of C10.
* This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
|
Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted)
n=14 Participants
* Participants were administered oral doses of 4 mg LY3493269 reference tablet formulation, co-administered with 300 mg of SNAC.
* This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
|
|---|---|---|---|
|
Part A: PK: Area Under the Concentration Versus Time Curve During One Dosing Interval (AUCτ) of LY3493269
|
150 nanograms*hours per milliliter(ng*h/mL)
Geometric Coefficient of Variation 69
|
402 nanograms*hours per milliliter(ng*h/mL)
Geometric Coefficient of Variation 66
|
1220 nanograms*hours per milliliter(ng*h/mL)
Geometric Coefficient of Variation 108
|
PRIMARY outcome
Timeframe: Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 14 and 24 hours (h) post-dosePopulation: All enrolled participants who received at least one dose of LY3493269 and had at least one evaluable PK data.
Cmax of LY3493269
Outcome measures
| Measure |
Part A: 4 mg LY3493269 Test Capsule 1 + 280 mg C10 (Fasted)
n=11 Participants
* Participants were administered oral doses of 4 mg LY3493269 test capsule formulation 1, co-administered with 280 mg of C10.
* This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
|
Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted)
n=15 Participants
* Participants were administered oral doses of 4 mg LY3493269 test capsule formulation 2, co-administered with 280 mg of C10.
* This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
|
Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted)
n=14 Participants
* Participants were administered oral doses of 4 mg LY3493269 reference tablet formulation, co-administered with 300 mg of SNAC.
* This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
|
|---|---|---|---|
|
Part A: PK: Maximum Observed Drug Concentration (Cmax) of LY3493269
|
7.49 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 80
|
25.8 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 73
|
70.4 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 108
|
Adverse Events
Part A: 4 mg LY3493269 Test Capsule 1 + 280 mg C10 (Fasted)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: 4 mg LY3493269 Test Capsule 1 + 280 mg C10 (Fasted)
n=11 participants at risk
* Participants were administered oral doses of 4 mg LY3493269 test capsule formulation 1, co-administered with 280 mg of C10.
* This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
|
Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted)
n=15 participants at risk
* Participants were administered oral doses of 4 mg LY3493269 test capsule formulation 2, co-administered with 280 mg of C10.
* This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
|
Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted)
n=14 participants at risk
* Participants were administered oral doses of 4 mg LY3493269 reference tablet formulation, co-administered with 300 mg of SNAC.
* This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
9.1%
1/11 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/14 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
Other adverse events
| Measure |
Part A: 4 mg LY3493269 Test Capsule 1 + 280 mg C10 (Fasted)
n=11 participants at risk
* Participants were administered oral doses of 4 mg LY3493269 test capsule formulation 1, co-administered with 280 mg of C10.
* This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
|
Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted)
n=15 participants at risk
* Participants were administered oral doses of 4 mg LY3493269 test capsule formulation 2, co-administered with 280 mg of C10.
* This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
|
Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted)
n=14 participants at risk
* Participants were administered oral doses of 4 mg LY3493269 reference tablet formulation, co-administered with 300 mg of SNAC.
* This regimen was administered once daily on Days 1, 2, and 3, following an overnight fast.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
9.1%
1/11 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
6.7%
1/15 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/14 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
7.1%
1/14 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
9.1%
1/11 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/14 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
7.1%
1/14 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
7.1%
1/14 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Gastrointestinal disorders
Diarrhoea
|
27.3%
3/11 • Number of events 5 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/14 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
7.1%
1/14 • Number of events 2 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
1/11 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
7.1%
1/14 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Gastrointestinal disorders
Flatulence
|
9.1%
1/11 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/14 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
14.3%
2/14 • Number of events 2 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
6.7%
1/15 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/14 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
7.1%
1/14 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Application site erythema
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
6.7%
1/15 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/14 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Asthenia
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
6.7%
1/15 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/14 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Catheter site bruise
|
9.1%
1/11 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
6.7%
1/15 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
14.3%
2/14 • Number of events 3 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Catheter site erythema
|
18.2%
2/11 • Number of events 3 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
13.3%
2/15 • Number of events 2 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
14.3%
2/14 • Number of events 2 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Catheter site pain
|
18.2%
2/11 • Number of events 2 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
6.7%
1/15 • Number of events 2 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
7.1%
1/14 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Catheter site phlebitis
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
14.3%
2/14 • Number of events 2 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Catheter site swelling
|
18.2%
2/11 • Number of events 2 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
13.3%
2/15 • Number of events 3 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
7.1%
1/14 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Early satiety
|
9.1%
1/11 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/14 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Fatigue
|
9.1%
1/11 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
7.1%
1/14 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Hunger
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
20.0%
3/15 • Number of events 3 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/14 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Medical device site erythema
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
13.3%
2/15 • Number of events 3 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
7.1%
1/14 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Medical device site reaction
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
6.7%
1/15 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/14 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Pyrexia
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
7.1%
1/14 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
7.1%
1/14 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Vessel puncture site erythema
|
9.1%
1/11 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/14 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
7.1%
1/14 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Infections and infestations
COVID-19
|
9.1%
1/11 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
7.1%
1/14 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
7.1%
1/14 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.1%
1/11 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
13.3%
2/15 • Number of events 2 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
28.6%
4/14 • Number of events 4 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
1/11 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
14.3%
2/14 • Number of events 2 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
7.1%
1/14 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
7.1%
1/14 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Nervous system disorders
Headache
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
14.3%
2/14 • Number of events 2 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
7.1%
1/14 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
7.1%
1/14 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
6.7%
1/15 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
7.1%
1/14 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
6.7%
1/15 • Number of events 2 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/14 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Renal and urinary disorders
Urinary retention
|
9.1%
1/11 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/14 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/14 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
9.1%
1/11 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/14 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
7.1%
1/14 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.1%
1/11 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
7.1%
1/14 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Skin and subcutaneous tissue disorders
Acne
|
9.1%
1/11 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/14 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
7.1%
1/14 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
7.1%
1/14 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
6.7%
1/15 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/14 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/15 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
7.1%
1/14 • Number of events 1 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
|
Vascular disorders
Hot flush
|
0.00%
0/11 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
6.7%
1/15 • Number of events 2 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
0.00%
0/14 • Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place