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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: LY3000328

Study type: Interventional

Funder types: Industry

Identifiers

NCT01515358

I5U-MC-ANBB (Other Identifier)

14340

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 35 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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18 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

LY3000328

Experimental group

Description:

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.

Treatment:

Drug: LY3000328