NCT01515358

Brief Summary

The purposes of this study are to determine the safety and side effects of LY3000328, to determine how well the body will tolerate LY3000328, and to determine how long LY3000328 remains in the body.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 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

First Submitted

Initial submission to the registry

January 18, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 31, 2012

Status Verified

May 1, 2012

Enrollment Period

3 months

First QC Date

January 18, 2012

Last Update Submit

May 30, 2012

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Number of participants with one or more drug related adverse events (AEs) or any serious AEs

    Baseline to study completion (estimate 3 months)

Secondary Outcomes (3)

  • Pharmacokinetics: Area under the concentration-time curve (AUC) of LY3000328

    Pre-dose up to Day 6 post-dose

  • Pharmacokinetics: Maximum concentration (Cmax) of LY3000328

    Pre-dose up to Day 6 post-dose

  • Change in Cathepsin S (CatS) activity

    Pre-dose, up to 48 hours post-dose

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Single dose of placebo administered orally in 1 out of 3 study periods separated by at least a 7-day wash-out period between each dose.

Drug: Placebo

LY3000328

EXPERIMENTAL

Single escalating dose of up to 300 mg/kg of LY3000328 administered orally in 2 out of 3 study periods separated by at least a 7 day wash-out period between each dose.

Drug: LY3000328

Interventions

PlaceboDRUG

Administered orally

Placebo
LY3000328DRUG

Administered orally

LY3000328

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Are overtly healthy males or females, as determined by medical history and physical examination

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.

Singapore, 117597, Singapore

Location

MeSH Terms

Interventions

LY3000328

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2012

First Posted

January 24, 2012

Study Start

February 1, 2012

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

May 31, 2012

Record last verified: 2012-05

Locations

SG(1)