Trial Outcomes & Findings for A Safety Study of LY3493269 in Healthy Participants (NCT NCT04498390)
NCT ID: NCT04498390
Last Updated: 2025-01-14
Results Overview
An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Baseline through Day 43
Results posted on
2025-01-14
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received placebo once daily (QD) administered orally over 3 consecutive study days.
|
Cohort 1: 8 Milligrams (mg) LY3493269 + 500 mg C10
Participants received 8 mg LY3493269 + 500 mg permeation enhancer sodium caprate(C10) QD administered orally over 3 consecutive study days.
|
Cohort 2: 24 mg LY3493269 + 500 mg C10
Participants received 24 mg LY3493269 + 500 mg C10 QD administered orally over 3 consecutive study days.
|
Cohort 3: 48 mg LY3493269 + 500 mg C10
Participants received 48 mg LY3493269 + 500 mg C10 QD administered orally over 3 consecutive study days.
|
Cohort 4: 24 mg LY3493269 + 250 mg C10
Participants received 24 mg LY3493269 + 250 mg C10 QD administered orally over 3 consecutive study days.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
Received at Least One Dose of Study Drug
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
7
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo once daily (QD) administered orally over 3 consecutive study days.
|
Cohort 1: 8 Milligrams (mg) LY3493269 + 500 mg C10
Participants received 8 mg LY3493269 + 500 mg permeation enhancer sodium caprate(C10) QD administered orally over 3 consecutive study days.
|
Cohort 2: 24 mg LY3493269 + 500 mg C10
Participants received 24 mg LY3493269 + 500 mg C10 QD administered orally over 3 consecutive study days.
|
Cohort 3: 48 mg LY3493269 + 500 mg C10
Participants received 48 mg LY3493269 + 500 mg C10 QD administered orally over 3 consecutive study days.
|
Cohort 4: 24 mg LY3493269 + 250 mg C10
Participants received 24 mg LY3493269 + 250 mg C10 QD administered orally over 3 consecutive study days.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Safety Study of LY3493269 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Placebo
n=8 Participants
Participants received placebo once daily (QD) administered orally over 3 consecutive study days.
|
Cohort 1: 8 mg LY3493269 + 500 mg C10
n=8 Participants
Participants received 8 milligrams (mg) LY3493269 + 500 mg permeation enhancer sodium caprate(C10) QD administered orally over 3 consecutive study days.
|
Cohort 2: 24 mg LY3493269 + 500 mg C10
n=8 Participants
Participants received 24 mg LY3493269 + 500 mg C10 QD administered orally over 3 consecutive study days.
|
Cohort 3: 48 mg LY3493269 + 500 mg C10
n=8 Participants
Participants received 48 mg LY3493269 + 500 mg C10 QD administered orally over 3 consecutive study days.
|
Cohort 4: 24 mg LY3493269 + 250 mg C10
n=8 Participants
Participants received 24 mg LY3493269 + 250 mg C10 QD administered orally over 3 consecutive study days.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
41.3 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
44.9 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
44.8 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
44.9 years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
43.9 years
STANDARD_DEVIATION 8.1 • n=21 Participants
|
43.9 years
STANDARD_DEVIATION 8.6 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
Singapore
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 43Population: All randomized participants who received at least one dose of study drug.
An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received placebo once daily (QD) administered orally over 3 consecutive study days.
|
8 mg LY3493269 + 500 mg C10
n=8 Participants
Participants received 8 milligrams (mg) LY3493269 + 500 mg permeation enhancer sodium caprate(C10) QD administered orally over 3 consecutive study days.
|
24 mg LY3493269 + 500 mg C10
n=8 Participants
Participants received 24 mg LY3493269 + 500 mg C10 QD administered orally over 3 consecutive study days.
|
48 mg LY3493269 + 500 mg C10
n=8 Participants
Participants received 48 mg LY3493269 + 500 mg C10 QD administered orally over 3 consecutive study days.
|
24 mg LY3493269 + 250 mg C10
n=8 Participants
Participants received 24 mg LY3493269 + 250 mg C10 QD administered orally over 3 consecutive study days.
|
|---|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 2. 6, 8, 12 and Day 2 predose; Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hours post dose, Day 4, pre-dosePopulation: All randomized participants received at least 1 full dose of LY3493269 and had evaluable PK sample. Participants may have been excluded from the PK summary statistics and statistical analysis if they had an adverse event of vomiting that occurred at or before 2 times median time to maximum observed drug Concentration (tmax)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3493269. Note: 1. 24 hour timepoint for Day 1 is the Day 2 pre-dose timepoint, which is the reason why Day 2 pre-dose is included in the timeframe. 2. 24 hour timepoint for Day 3 is the Day 4 pre-dose timepoint, which is the reason why Day 4 pre-dose is included in the timeframe.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received placebo once daily (QD) administered orally over 3 consecutive study days.
|
8 mg LY3493269 + 500 mg C10
n=7 Participants
Participants received 8 milligrams (mg) LY3493269 + 500 mg permeation enhancer sodium caprate(C10) QD administered orally over 3 consecutive study days.
|
24 mg LY3493269 + 500 mg C10
n=8 Participants
Participants received 24 mg LY3493269 + 500 mg C10 QD administered orally over 3 consecutive study days.
|
48 mg LY3493269 + 500 mg C10
n=8 Participants
Participants received 48 mg LY3493269 + 500 mg C10 QD administered orally over 3 consecutive study days.
|
24 mg LY3493269 + 250 mg C10
Participants received 24 mg LY3493269 + 250 mg C10 QD administered orally over 3 consecutive study days.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3493269 From Day 1 and Day 3 Doses
Day 1
|
11.7 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 176
|
39.9 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 248
|
80.8 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 359
|
68.2 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 97
|
—
|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3493269 From Day 1 and Day 3 Doses
Day 3
|
17.7 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 149
|
49.1 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 449
|
41.9 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 157
|
69.4 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 263
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and Day 2 predose; Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hours post dose, Day 4, pre-dosePopulation: All randomized participants received at least 1 full dose of LY3493269 and had evaluable PK sample. Participants may have been excluded from the PK summary statistics and statistical analysis if they had an adverse event of vomiting that occurred at or before 2 times median time to maximum observed drug Concentration (tmax).
PK: Area Under the Concentration Versus Time Curve From Zero to 24 (AUC\[0-24\]) of LY3493269 From Day 1 and Day 3 Doses Note: 1. 24 hour timepoint for Day 1 is the Day 2 pre-dose timepoint, which is the reason why Day 2 pre-dose is included in the timeframe. 2. 24 hour timepoint for Day 3 is the Day 4 pre-dose timepoint, which is the reason why Day 4 pre-dose is included in the timeframe.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants received placebo once daily (QD) administered orally over 3 consecutive study days.
|
8 mg LY3493269 + 500 mg C10
n=7 Participants
Participants received 8 milligrams (mg) LY3493269 + 500 mg permeation enhancer sodium caprate(C10) QD administered orally over 3 consecutive study days.
|
24 mg LY3493269 + 500 mg C10
n=8 Participants
Participants received 24 mg LY3493269 + 500 mg C10 QD administered orally over 3 consecutive study days.
|
48 mg LY3493269 + 500 mg C10
n=8 Participants
Participants received 48 mg LY3493269 + 500 mg C10 QD administered orally over 3 consecutive study days.
|
24 mg LY3493269 + 250 mg C10
Participants received 24 mg LY3493269 + 250 mg C10 QD administered orally over 3 consecutive study days.
|
|---|---|---|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Zero to 24 (AUC[0-24]) of LY3493269 From Day 1 and Day 3 Doses
Day 1
|
170 Nanograms hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 185
|
601 Nanograms hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 310
|
1180 Nanograms hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 381
|
1080 Nanograms hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 104
|
—
|
|
PK: Area Under the Concentration Versus Time Curve From Zero to 24 (AUC[0-24]) of LY3493269 From Day 1 and Day 3 Doses
Day 3
|
302 Nanograms hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 139
|
868 Nanograms hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 381
|
746 Nanograms hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 156
|
1340 Nanograms hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 276
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
8 mg LY3493269 + 500 mg C10
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
24 mg LY3493269 + 500 mg C10
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
48 mg LY3493269 + 500 mg C10
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
24 mg LY3493269 + 250 mg C10
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=8 participants at risk
Participants received placebo once daily (QD) administered orally over 3 consecutive study days.
|
8 mg LY3493269 + 500 mg C10
n=8 participants at risk
Participants received 8 milligrams (mg) LY3493269 + 500 mg permeation enhancer sodium caprate(C10) QD administered orally over 3 consecutive study days.
|
24 mg LY3493269 + 500 mg C10
n=8 participants at risk
Participants received 24 mg LY3493269 + 500 mg C10 QD administered orally over 3 consecutive study days.
|
48 mg LY3493269 + 500 mg C10
n=8 participants at risk
Participants received 48 mg LY3493269 + 500 mg C10 QD administered orally over 3 consecutive study days.
|
24 mg LY3493269 + 250 mg C10
n=8 participants at risk
Participants received 24 mg LY3493269 + 250 mg C10 QD administered orally over 3 consecutive study days.
|
|---|---|---|---|---|---|
|
General disorders
Medical device site pain
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
General disorders
Medical device site pruritus
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
|
General disorders
Medical device site reaction
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
25.0%
2/8 • Number of events 2 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
General disorders
Pyrexia
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
|
Injury, poisoning and procedural complications
Scratch
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
25.0%
2/8 • Number of events 2 • Baseline Up To 43 Days
|
|
Investigations
Amylase increased
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
Investigations
Blood pressure increased
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
Investigations
Lipase increased
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/8 • Baseline Up To 43 Days
|
25.0%
2/8 • Number of events 2 • Baseline Up To 43 Days
|
50.0%
4/8 • Number of events 4 • Baseline Up To 43 Days
|
25.0%
2/8 • Number of events 2 • Baseline Up To 43 Days
|
37.5%
3/8 • Number of events 3 • Baseline Up To 43 Days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Baseline Up To 43 Days
|
50.0%
4/8 • Number of events 5 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
25.0%
2/8 • Number of events 2 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
Nervous system disorders
Migraine
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
Eye disorders
Eye pain
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
25.0%
2/8 • Number of events 2 • Baseline Up To 43 Days
|
25.0%
2/8 • Number of events 2 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
37.5%
3/8 • Number of events 3 • Baseline Up To 43 Days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
2/8 • Number of events 2 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 3 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • Baseline Up To 43 Days
|
37.5%
3/8 • Number of events 5 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
25.0%
2/8 • Number of events 2 • Baseline Up To 43 Days
|
25.0%
2/8 • Number of events 4 • Baseline Up To 43 Days
|
37.5%
3/8 • Number of events 3 • Baseline Up To 43 Days
|
25.0%
2/8 • Number of events 2 • Baseline Up To 43 Days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
25.0%
2/8 • Number of events 10 • Baseline Up To 43 Days
|
25.0%
2/8 • Number of events 5 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
General disorders
Application site erythema
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
General disorders
Application site pruritus
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
General disorders
Catheter site bruise
|
25.0%
2/8 • Number of events 3 • Baseline Up To 43 Days
|
25.0%
2/8 • Number of events 2 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
25.0%
2/8 • Number of events 2 • Baseline Up To 43 Days
|
25.0%
2/8 • Number of events 2 • Baseline Up To 43 Days
|
|
General disorders
Catheter site erythema
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 2 • Baseline Up To 43 Days
|
25.0%
2/8 • Number of events 2 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
|
General disorders
Catheter site pain
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
|
General disorders
Catheter site phlebitis
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
|
General disorders
Catheter site pruritus
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
General disorders
Catheter site swelling
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
|
General disorders
Chest pain
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
|
General disorders
Medical device site erythema
|
50.0%
4/8 • Number of events 4 • Baseline Up To 43 Days
|
37.5%
3/8 • Number of events 4 • Baseline Up To 43 Days
|
87.5%
7/8 • Number of events 9 • Baseline Up To 43 Days
|
62.5%
5/8 • Number of events 5 • Baseline Up To 43 Days
|
62.5%
5/8 • Number of events 6 • Baseline Up To 43 Days
|
|
General disorders
Medical device site injury
|
0.00%
0/8 • Baseline Up To 43 Days
|
12.5%
1/8 • Number of events 1 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
0.00%
0/8 • Baseline Up To 43 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60