NCT01534273

Brief Summary

The purpose of this phase I study in healthy participants will be to evaluate the safety and tolerability of LY2886721 single and multiple doses, to evaluate how the body handles the drug, and to evaluate the drug's effect on the body.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 16, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
7.2 years until next milestone

Results Posted

Study results publicly available

August 28, 2019

Completed
Last Updated

August 28, 2019

Status Verified

July 1, 2019

Enrollment Period

5 months

First QC Date

February 13, 2012

Results QC Date

May 13, 2019

Last Update Submit

July 22, 2019

Conditions

Healthy Volunteers

Keywords

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Clinically Significant Effects

    Data presented are the number of participants who experienced treatment-emergent adverse events. A summary of serious adverse events and other non-serious adverse events, regardless of causality is reported in the Adverse Events module.

    Predose up to Day 23

Secondary Outcomes (6)

  • Pharmacokinetics: Plasma Maximum Observed Concentration (Cmax) of LY2886721

    Day 1 predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose

  • Pharmacokinetics: Plasma Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of LY2886721

    Day 1 predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose

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

    Day 14 predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours postdose

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

    Day 14 predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours postdose

  • Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid 1-40 Concentration at Day 15

    Baseline, Day 15

  • +1 more secondary outcomes

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Single oral dose and/or once daily (QD) oral dosing for 14 consecutive days

Drug: Placebo

35 mg LY2886721

EXPERIMENTAL

QD oral dosing for 14 consecutive days

Drug: LY2886721

70 mg LY2886721

EXPERIMENTAL

Single oral dose or single oral dose followed by QD oral dosing for 14 consecutive days

Drug: LY2886721

140 mg LY2886721

EXPERIMENTAL

Single oral dose

Drug: LY2886721

Interventions

LY2886721DRUG

Administered orally.

140 mg LY288672135 mg LY288672170 mg LY2886721
PlaceboDRUG

Administered orally.

Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy men and non-childbearing potential women
  • Body mass index (BMI) between 18.0 and 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Cognitive Dysfunction

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)

Cognition DisordersNeurocognitive DisordersMental 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

February 13, 2012

First Posted

February 16, 2012

Study Start

February 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 28, 2019

Results First Posted

August 28, 2019

Record last verified: 2019-07

Locations

US(1)