A Safety Study of LY2886721 Single Doses in Healthy Subjects

NCT01133405 | Completed Phase 1 Results

• 2 other identifiers: 13733I4O-MC-BACA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of LY2886721 single 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 (Adverse Events)

  A summary of serious adverse events and other nonserious adverse events located in Reported Adverse Event section. To assess effect of food on pharmacokinetics of LY2886721, participants in Cohort B during Period 3 (1 period=8 days) of Part 1 fasted overnight for at least 8 hours prior to receiving a single 7-milligram (mg) oral dose of LY2886721 in the fed state (Part 1 - Fed). Participants in other LY2886721 groups received LY2886721 in fasted state. Due to crossover design in Part 1, results reported by treatment; thus, participants are included in multiple arms.

  Predose to 10-14 days after final dose of study drug (up to 42 days)

Secondary Outcomes (6)

• Maximum Observed Plasma Concentration (Cmax) of LY2886721

  0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose

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

  0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose

• Pharmacodynamic Biomarker: Plasma Amyloid Beta (Aβ) 1-40 Concentration (Part 1 Only)

  0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose

• Cerebrospinal Fluid (CSF) Maximum Observed Drug Concentration (Cmax) of LY2886721 (Part 2 Only)

  Predose and up to 36 hours postdose

• Cerebrospinal Fluid (CSF) Pharmacodynamic Biomarker Amyloid Beta (Aβ) 1-40 Concentration (Part 2 Only)

  Predose and up to 36 hours postdose

Study Arms (5)

LY2886721 Part 1: Cohort A/B

EXPERIMENTAL

Single (7 milligram (mg), 15 mg, 25 mg, 35 mg) doses of LY2886721 administered orally in up to three of three study periods

Drug: LY2886721

Placebo Part 1: Cohort A/B

PLACEBO COMPARATOR

Single dose in up to 1 period

Drug: Placebo

LY2886721 Part 2: Cohort C

EXPERIMENTAL

Single 10 mg dose of LY2886721, dose determined by Part 1

Drug: LY2886721

LY2886721 Part 2: Cohort D

EXPERIMENTAL

Single 35 mg dose of LY2886721, dose determined by Part 1

Drug: LY2886721

Placebo Part 2: Cohort C/D

PLACEBO COMPARATOR

Single dose

Drug: Placebo

Interventions

LY2886721 DRUG

Oral capsules

LY2886721 Part 1: Cohort A/B; LY2886721 Part 2: Cohort C; LY2886721 Part 2: Cohort D

Placebo DRUG

Oral capsules

Placebo Part 1: Cohort A/B; Placebo Part 2: Cohort C/D

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 nonchild-bearing potential women
• years or older
• Body mass index between 18-32 kilograms per square meter (kg/m\^2)

You may not qualify if:

• Taking over-the-counter or prescription medication with the exception of vitamins or minerals or stable doses of thyroid or estrogen hormone replacement
• Smoke more than 10 cigarettes 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.

Beverly Hills, California, 90211, 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

ClinicalTrials.gov@lilly.com

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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: May 28, 2010
• Study Start: June 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: September 16, 2019
• Results First Posted: September 16, 2019

Record last verified: 2019-05

Locations

US (1)