Trial Outcomes & Findings for A Study of Donanemab (LY3002813) in Healthy Participants (NCT NCT05567159)
NCT ID: NCT05567159
Last Updated: 2024-10-04
Results Overview
As per the prespecified analysis, AUC\[0-4 weeks\] will be calculated as the sum of AUC0-2weeks for: * treatment period 1 and 2 (dosing days 1, 15 respectively) represented as period 2 * treatment period 3 and 4 (dosing days 29, 43 respectively) represented as period 4 * treatment period 5 and 6 (dosing days 57, 71 respectively) represented as period 6.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
42 participants
Primary outcome timeframe
Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on days 1, 15, 29, 43, 57, 71
Results posted on
2024-10-04
Participant Flow
Participant milestones
| Measure |
Donanemab
Participants received a 350 milligrams (mg) intravenous (IV) infusion of donanemab every two weeks for six treatment periods (1 to 6), each lasting two weeks. Treatments were administered on the first day of each period, i.e., days 1, 15, 29, 43, 57, and 71.
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|---|---|
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Overall Study
STARTED
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42
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Overall Study
Received at Least One IV Infusion of Donanemab
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42
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Overall Study
COMPLETED
|
34
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Overall Study
NOT COMPLETED
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8
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Reasons for withdrawal
| Measure |
Donanemab
Participants received a 350 milligrams (mg) intravenous (IV) infusion of donanemab every two weeks for six treatment periods (1 to 6), each lasting two weeks. Treatments were administered on the first day of each period, i.e., days 1, 15, 29, 43, 57, and 71.
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|---|---|
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Overall Study
Adverse Event
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4
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Overall Study
Physician Decision
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3
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Overall Study
Protocol deviation
|
1
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Baseline Characteristics
A Study of Donanemab (LY3002813) in Healthy Participants
Baseline characteristics by cohort
| Measure |
Donanemab
n=42 Participants
Participants received a 350 mg IV infusion of donanemab every two weeks for six treatment periods (1 to 6), each lasting two weeks. Treatments were administered on the first day of each period, i.e., days 1, 15, 29, 43, 57, and 71.
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|---|---|
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Age, Continuous
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28.9 years
STANDARD_DEVIATION 5.4 • n=5 Participants
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Sex: Female, Male
Female
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0 Participants
n=5 Participants
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Sex: Female, Male
Male
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42 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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14 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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28 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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10 Participants
n=5 Participants
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|
Race (NIH/OMB)
White
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28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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2 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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42 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on days 1, 15, 29, 43, 57, 71Population: All enrolled participants who received at least one IV infusion of donanemab and had evaluable PK data.
As per the prespecified analysis, AUC\[0-4 weeks\] will be calculated as the sum of AUC0-2weeks for: * treatment period 1 and 2 (dosing days 1, 15 respectively) represented as period 2 * treatment period 3 and 4 (dosing days 29, 43 respectively) represented as period 4 * treatment period 5 and 6 (dosing days 57, 71 respectively) represented as period 6.
Outcome measures
| Measure |
Donanemab
n=27 Participants
Participants received a 350 mg IV infusion of donanemab every two weeks for six treatment periods (1 to 6), each lasting two weeks. Treatments were administered on the first day of each period, i.e., days 1, 15, 29, 43, 57, and 71.
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|---|---|
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Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Four Weeks (AUC[0-4 Weeks]) of Donanemab (i.e) Period 2, Period 4, Period 6.
Period 2
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17300 microgram*hour per milliliter (μg*h/mL)
Geometric Coefficient of Variation 23
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Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Four Weeks (AUC[0-4 Weeks]) of Donanemab (i.e) Period 2, Period 4, Period 6.
Period 4
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15400 microgram*hour per milliliter (μg*h/mL)
Geometric Coefficient of Variation 32
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Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Four Weeks (AUC[0-4 Weeks]) of Donanemab (i.e) Period 2, Period 4, Period 6.
Period 6
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15500 microgram*hour per milliliter (μg*h/mL)
Geometric Coefficient of Variation 45
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PRIMARY outcome
Timeframe: Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on day 71Population: All enrolled participants who received at least one IV infusion of donanemab and had evaluable PK data.
PK: Cmax, ss of Donanemab
Outcome measures
| Measure |
Donanemab
n=27 Participants
Participants received a 350 mg IV infusion of donanemab every two weeks for six treatment periods (1 to 6), each lasting two weeks. Treatments were administered on the first day of each period, i.e., days 1, 15, 29, 43, 57, and 71.
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|---|---|
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PK: Maximum Observed Concentration During a Dosing Interval at Steady State (Cmax, ss) of Donanemab
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112 μg/mL
Geometric Coefficient of Variation 21
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PRIMARY outcome
Timeframe: Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on day 71Population: All enrolled participants who received at least one IV infusion of donanemab and had evaluable PK data.
PK: AUCτ,ss of Donanemab
Outcome measures
| Measure |
Donanemab
n=27 Participants
Participants received a 350 mg IV infusion of donanemab every two weeks for six treatment periods (1 to 6), each lasting two weeks. Treatments were administered on the first day of each period, i.e., days 1, 15, 29, 43, 57, and 71.
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|---|---|
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PK: Area Under the Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCτ,ss) of Donanemab
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7590 μg*h/mL
Geometric Coefficient of Variation 50
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Adverse Events
Donanemab
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Donanemab
n=42 participants at risk
Participants received a 350 mg IV infusion of donanemab every two weeks for six treatment periods (1 to 6), each lasting two weeks. Treatments were administered on the first day of each period, i.e., days 1, 15, 29, 43, 57, and 71.
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|---|---|
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Infections and infestations
Upper respiratory tract infection
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9.5%
4/42 • Number of events 4 • Baseline to Week 22
All enrolled participants who received at least one IV infusion of donanemab.
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Injury, poisoning and procedural complications
Infusion related reaction
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16.7%
7/42 • Number of events 12 • Baseline to Week 22
All enrolled participants who received at least one IV infusion of donanemab.
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Investigations
Blood creatine phosphokinase increased
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7.1%
3/42 • Number of events 3 • Baseline to Week 22
All enrolled participants who received at least one IV infusion of donanemab.
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Nervous system disorders
Headache
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31.0%
13/42 • Number of events 15 • Baseline to Week 22
All enrolled participants who received at least one IV infusion of donanemab.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60