A Study to Evaluate the Safety and Tolerability of LY3000328 in Healthy Participants

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT01515358

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Placebo Drug: LY3000328	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Single-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3000328 in Healthy Subjects

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo 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 Administered orally
Experimental: LY3000328 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 Administered orally

Arm

Intervention/Treatment

Placebo Comparator: Placebo

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

Administered orally

Experimental: LY3000328

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

Administered orally

Outcome Measures

Primary Outcome Measures

Number of participants with one or more drug related adverse events (AEs) or any serious AEs [Baseline to study completion (estimate 3 months)]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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		Singapore	117597

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT01515358

Other Study ID Numbers:

14340
I5U-MC-ANBB

First Posted:

Jan 24, 2012

Last Update Posted:

May 31, 2012

Last Verified:

May 1, 2012

Study Results

No Results Posted as of May 31, 2012