A Study of LY3323795 in Healthy Participants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-12

Study Completion Date

2017-07-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The main purpose of this study is to investigate the safety of LY3323795 and the effects it has on the body. The study drug or placebo (sugar pill) will be given by mouth to healthy participants. The study has three parts. Each participant may only enroll in one part. The study will last 14 to 43 days, depending on the part. Screening must be completed prior to study start.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of the Effects of Itraconazole or Carbamazepine on LY3537982 in Healthy Participants

NCT05860933

Healthy

COMPLETED PHASE1

A Study of LY3154207 in Healthy Participants

NCT02365571

Healthy Participants

COMPLETED PHASE1

A Study of LY2775240 in Healthy Participants

NCT02963779

Healthy

COMPLETED PHASE1

A Study of LY3361237 in Healthy Participants

NCT03695198

Healthy

COMPLETED PHASE1

A Safety Study of LY3372689 Given By Mouth to Healthy Participants

NCT03819270

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LY3323795 (Part A)

Participants received escalating doses of 0.3 mg (milligrams), 1 mg, 3 mg, 10 mg, 30 mg and 100 mg of LY3323795 orally.

Group Type EXPERIMENTAL

LY3323795

Intervention Type DRUG

Administered orally

Placebo (Part A)

Participants received placebo identical to LY3323795 orally.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

LY3323795 (Part B)

Participants received 6 mg, 20 mg and 80 mg of LY3323795 orally.

Group Type EXPERIMENTAL

LY3323795

Intervention Type DRUG

Administered orally

Placebo (Part B)

Participants received placebo identical to LY3323795 orally.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

LY3323795 (Part C)

Part C was not initiated due to a Lilly internal strategy decision.

Group Type EXPERIMENTAL

LY3323795

Intervention Type DRUG

Administered orally

LY3323795 + Itraconazole (Part C)

Part C was not initiated due to a Lilly internal strategy decision.

Group Type EXPERIMENTAL

LY3323795

Intervention Type DRUG

Administered orally

Itraconazole

Intervention Type DRUG

Administered orally

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LY3323795

Administered orally

Intervention Type DRUG

Itraconazole

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy males or females of non-childbearing potential at time of screening
* Have a body mass index (BMI) between 18.0 kilograms per square meter (kg/m²) and 32.0 kg/m², inclusive

Exclusion Criteria

* Have participated, within the last 30 days, in a clinical trial involving an investigational product.
* Have a QT corrected for heart rate (QTc) (using Bazett's formula) interval value of greater than 450 millisecond (msec) (males) or greater than 470 msec (females)

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes