Sponsor study identifier
Secondary identifiers
OTHER · Eli Lilly and Company
interventional
42
1 country
1
Study Start
October 4, 2022
Actual (reported)Primary Completion
July 14, 2023
Actual (reported)Study Completion
July 14, 2023
Actual (reported)The main purpose of this study is to assess how fast donanemab (LY3002813) gets into the blood stream and how long it takes the body to remove it when administered as single dose in healthy participants. The study will also evaluate the safety and tolerability of donanemab. The study will last up to approximately 22 weeks.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 14, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 3, 2022
Actual (reported)October 4, 2022
Actual (reported)October 5, 2022
Actual (reported)July 14, 2023
Actual (reported)July 14, 2023
Actual (reported)October 4, 2024
Actual (reported)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.
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.
Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on days 1, 15, 29, 43, 57, 71
PK: Maximum Observed Concentration During a Dosing Interval at Steady State (Cmax, ss) of Donanemab
PK: Cmax, ss of Donanemab
Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on day 71
PK: Area Under the Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCτ,ss) of Donanemab
PK: AUCτ,ss of Donanemab
Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on day 71
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.
Administered IV.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
ICON Early Phase Services Lenexa Center
Salt Lake City, Utah, 84124, United States
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
42 participants (actual enrollment reported by the registry).
First Submitted
October 3, 2022
First Posted
October 5, 2022
Study Start
October 4, 2022
Actual (reported)A Study of Effect of LY3556050 on Metformin in Healthy Participants
A Bioequivalence Study of Mirikizumab (LY3074828) in Healthy Participants
Contact the study team to confirm eligibility.
Primary Completion
July 14, 2023
Actual (reported)Study Completion
July 14, 2023
Actual (reported)Last Updated
October 4, 2024
Results First Posted
October 4, 2024
Record last verified: 2024-07-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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