A Safety Study of LY2886721 Multiple Doses in Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT01227252|
Recruitment Status : Completed
First Posted : October 25, 2010
Results First Posted : July 19, 2019
Last Update Posted : July 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: LY2886721 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
5 milligrams (mg) up to 35 mg, administered orally as capsules, daily for 14 days
|Placebo Comparator: Placebo||
Administered orally as capsules, daily for 14 days
- Number of Participants With Clinically Significant Effects [ Time Frame: Predose up to Day 70 ]Clinically significant effects were defined as serious and nonserious adverse events. A summary of serious and all other nonserious adverse events is located in the Reported Adverse Event module. The number of participants with at least 1 adverse event in each treatment arm is reported for this outcome measure.
- Plasma Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY2886721 [ Time Frame: Predose (Day 14) up to Day 19 ]
- Plasma Area Under the Concentration Versus Time Curve (AUC) of LY2886721 [ Time Frame: Predose (Day 14) to 24 Hours post-dose (Day 15) ]Area under the concentration versus time curve during 1 dosing interval (1 dosing interval=24 hours) at steady state (AUCτ,ss) is being reported for this outcome measure.
- Plasma Amyloid Beta (Aβ) 1-40 Concentration [ Time Frame: Predose (Day 14) up to Day 19 ]The minimum concentration (Cnadir) is being reported for this outcome measure.
- Cerebrospinal Fluid (CSF) Concentration of LY2886721 [ Time Frame: 24 Hours post-dose (Day 15) ]
- Change From Baseline to Day 15 Endpoint in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ) 1-40 Concentration [ Time Frame: Predose (Day 14), 24 Hours post-dose (Day 15) ]The Least Squares means were adjusted for baseline concentration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01227252
|United States, California|
|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.|
|Glendale, California, United States, 91206|
|Study Director:||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|