A Study of LY3337641 in Japanese and Caucasian Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: LY3337641

Study type: Interventional

Funder types: Industry

Identifiers

NCT03083561

16174

I8K-JE-JPDB (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to evaluate the safety and tolerability of LY3337641 in healthy Japanese and Caucasian participants. The study will also investigate how the body processes LY3337641 and the effect of LY3337641 on the body. The study will last up to 4 weeks for each participant. Screening may occur within 28 days prior to first dose of study drug.

Enrollment: 36 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Overtly healthy Japanese or Caucasian
• Body mass index (BMI) 18.0 - 32.0 kilograms per square meter (kg/m²)

Exclusion criteria

• Are currently enrolled in a clinical trial involving an investigational product or off-label use of a drug or device or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
• Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer, if known) should have passed
• Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study or affects or confounds the QTc analysis or have Fridericia-corrected QT interval (QTcF) >450 milliseconds (msec) for males and >470 msec for females
• Have had symptomatic herpes zoster within 3 months of screening
• Have active or latent tuberculosis (TB) based on a positive medical history, examination, and/or TB test results.
• Have received live vaccine(s) within 1 month of screening or intend to during the study
• Are immunocompromised
• Have a history of constipation or have had acute constipation within 3 weeks prior to admission

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 4 patient groups, including a placebo group

LY3337641 Multiple Dose

Experimental group

Description:

Multiple doses of 30 mg LY3337641 tablet administered orally every day for two weeks, with a two week follow-up period.

Treatment:

Drug: LY3337641

Placebo Multiple Dose

Placebo Comparator group

Description:

Multiple doses of placebo administered orally every day for two weeks, with a two week follow-up period.

Treatment:

Drug: Placebo

LY3337641 Single Dose

Experimental group

Description:

Single dose of 5 mg, 80 mg and 160 mg LY3337641 tablet administered orally, with a two week follow-up period.

Treatment:

Drug: LY3337641

Placebo Single Dose

Placebo Comparator group

Description:

Single dose of placebo administered orally, with a two week follow-up period.

Treatment:

Drug: Placebo