Trial Outcomes & Findings for A Study of LY3478006 in Healthy Participants (NCT NCT04230122)
NCT ID: NCT04230122
Last Updated: 2021-12-06
Results Overview
Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
4 participants
Primary outcome timeframe
Baseline through study completion (up to 109 days)
Results posted on
2021-12-06
Participant Flow
Participant milestones
| Measure |
10 Milligram (mg) LY3478006 - Intravenous (IV)
Participants received single dose of 10 mg LY3478006 administered IV.
|
Placebo - IV
Participants received single dose of placebo administered IV.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
3
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
10 Milligram (mg) LY3478006 - Intravenous (IV)
Participants received single dose of 10 mg LY3478006 administered IV.
|
Placebo - IV
Participants received single dose of placebo administered IV.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
A Study of LY3478006 in Healthy Participants
Baseline characteristics by cohort
| Measure |
10 mg LY3478006 - IV
n=3 Participants
Participants received single dose of 10 mg LY3478006 administered IV.
|
Placebo - IV
n=1 Participants
Participants received single dose of placebo administered IV.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.7 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
33 years
STANDARD_DEVIATION NA • n=7 Participants
|
34.3 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through study completion (up to 109 days)Population: All randomized participants who received at least one dose of study drug.
Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.
Outcome measures
| Measure |
10 mg LY3478006 - IV
n=3 Participants
Participants received single dose of 10 mg LY3478006 administered IV.
|
Placebo - IV
n=1 Participants
Participants received single dose of placebo administered IV.
|
|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Predose; Day 1 with end of infusion, 3, 6, 12 hoursPopulation: All randomized participants who received at least one dose of study drug and had evaluable pharmacokinetic data.
Cmax of LY3478006 was evaluated.
Outcome measures
| Measure |
10 mg LY3478006 - IV
n=3 Participants
Participants received single dose of 10 mg LY3478006 administered IV.
|
Placebo - IV
Participants received single dose of placebo administered IV.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3478006
|
2.3 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 22
|
—
|
SECONDARY outcome
Timeframe: Predose; Day 1 with end of infusion, 3, 6, 12 hours; Day 2; Day 3; Day 5; Day 8; Day 10; Day 15; Day 22; Day 29; Day 43; Day 57; Day 71 and Day 85Population: All randomized participants who received at least one dose of study drug and had evaluable pharmacokinetic data.
AUC0-∞ of LY3478006 was evaluated. The unit of measure is hour\*microgram per milliliter (hr\*mcg/mL).
Outcome measures
| Measure |
10 mg LY3478006 - IV
n=3 Participants
Participants received single dose of 10 mg LY3478006 administered IV.
|
Placebo - IV
Participants received single dose of placebo administered IV.
|
|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC0-∞) of LY3478006
|
550 hr*mcg/mL
Geometric Coefficient of Variation 8.03
|
—
|
Adverse Events
10 mg LY3478006 IV
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo IV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
10 mg LY3478006 IV
n=3 participants at risk
Participants received single dose of placebo administered IV.
|
Placebo IV
n=1 participants at risk
Participants received single dose of 10 mg LY3478006 administered IV.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
100.0%
3/3 • Number of events 3 • Baseline through study completion (up to 109 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline through study completion (up to 109 days)
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
100.0%
3/3 • Number of events 3 • Baseline through study completion (up to 109 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline through study completion (up to 109 days)
All randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
10 mg LY3478006 IV
n=3 participants at risk
Participants received single dose of placebo administered IV.
|
Placebo IV
n=1 participants at risk
Participants received single dose of 10 mg LY3478006 administered IV.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Baseline through study completion (up to 109 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline through study completion (up to 109 days)
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
33.3%
1/3 • Number of events 1 • Baseline through study completion (up to 109 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline through study completion (up to 109 days)
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Number of events 1 • Baseline through study completion (up to 109 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline through study completion (up to 109 days)
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 2 • Baseline through study completion (up to 109 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline through study completion (up to 109 days)
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • Number of events 4 • Baseline through study completion (up to 109 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline through study completion (up to 109 days)
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • Baseline through study completion (up to 109 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline through study completion (up to 109 days)
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
33.3%
1/3 • Number of events 1 • Baseline through study completion (up to 109 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline through study completion (up to 109 days)
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 1 • Baseline through study completion (up to 109 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Baseline through study completion (up to 109 days)
All randomized participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER