A Safety Study of LY2886721 Multiple Doses in Healthy Subjects

Alzheimer's Disease Clinical Trial

Official title:

Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01227252
• Other study ID #: 13734
• Secondary ID: I4O-MC-BACB
• Status: Completed
• Phase: Phase 1
• Start date: December 2010
• Est. completion date: April 2011

Study information

• Verified date: May 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of LY2886721 multiple doses, how the body handles the drug, and the drug's effect on the body.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Healthy men and non-childbearing potential women

• Body mass index between 18.0-32.0 kilograms per square meter (kg/m^2)

• Are reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures and research unit policies

Exclusion Criteria:

• Taking over-the-counter or prescription medication with the exception of vitamins or minerals

• Smoke more than 10 cigarettes per day

• Drink more than 5 cups of caffeine containing beverages (for example, coffee, tea) per day

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• LY2886721
5 milligrams (mg) up to 35 mg, administered orally as capsules, daily for 14 days
• Placebo
Administered orally as capsules, daily for 14 days

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Clinically Significant Effects	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.	Predose up to Day 70
Secondary	Plasma Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY2886721		Predose (Day 14) up to Day 19
Secondary	Plasma Area Under the Concentration Versus Time Curve (AUC) of LY2886721	Area under the concentration versus time curve during 1 dosing interval (1 dosing interval=24 hours) at steady state (AUCt,ss) is being reported for this outcome measure.	Predose (Day 14) to 24 Hours post-dose (Day 15)
Secondary	Plasma Amyloid Beta (Aß) 1-40 Concentration	The minimum concentration (Cnadir) is being reported for this outcome measure.	Predose (Day 14) up to Day 19
Secondary	Cerebrospinal Fluid (CSF) Concentration of LY2886721		24 Hours post-dose (Day 15)
Secondary	Change From Baseline to Day 15 Endpoint in Cerebrospinal Fluid (CSF) Amyloid Beta (Aß) 1-40 Concentration	The Least Squares means were adjusted for baseline concentration.	Predose (Day 14), 24 Hours post-dose (Day 15)