A Safety Study of LY2886721 Multiple Doses in Healthy Subjects

NCT01227252 | Completed Phase 1 Results

• 2 other identifiers: 13734I4O-MC-BACB
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Plasma Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY2886721

  Predose (Day 14) up to Day 19

• Plasma Area Under the Concentration Versus Time Curve (AUC) of LY2886721

  Predose (Day 14) to 24 Hours post-dose (Day 15)

• Plasma Amyloid Beta (Aβ) 1-40 Concentration

  Predose (Day 14) up to Day 19

• Cerebrospinal Fluid (CSF) Concentration of LY2886721

  24 Hours post-dose (Day 15)

• Change From Baseline to Day 15 Endpoint in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ) 1-40 Concentration

  Predose (Day 14), 24 Hours post-dose (Day 15)

Study Arms (2)

LY2886721

EXPERIMENTAL

Drug: LY2886721

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

LY2886721 DRUG

5 milligrams (mg) up to 35 mg, administered orally as capsules, daily for 14 days

LY2886721

Placebo DRUG

Administered orally as capsules, daily for 14 days

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, 91206, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

N-(3-(2-amino-4a,5,7,7a-tetrahydro-4H-furo(3,4-d)(1,3)thiazin-7a-yl)-4-fluorophenyl)-5-fluoropicolinamide

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2010
• First Posted: October 25, 2010
• Study Start: December 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: July 19, 2019
• Results First Posted: July 19, 2019

Record last verified: 2019-05

Locations

US (1)