A Study of LY4268989 (MORF-057) in Healthy Participants

Lilly

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: LY4268989; Drug: Midazolam

Study type: Interventional

Funder types: Industry

Identifiers

NCT06964776

MORF-057 (Other Identifier)

27387

J6E-MC-KWAC (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to measure the body's absorption and processing of the study drug, the study drug's effect on the body, safety, and tolerability with LY4268989 (MORF-57) in healthy participants, including Japanese and Chinese participants

Enrollment: 114 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Are healthy as determined by medical evaluation including medical history, physical examination, laboratory test, electrocardiograms (ECGs), and vital signs.
• Cohort 5 includes Japanese participants. To qualify, the participants must be first-generation Japanese in the US, defined as the participant's biological parents, and all the participant's biological grandparents, being of exclusive Japanese descent, and being born in Japan.
• Cohort 5 includes Chinese participants. To qualify as Chinese for this study, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China.
• Have a body mass index within the range of 18.0 to 32.0 kilogram/square meter (kilogram/m²), inclusive, at screening.

Exclusion criteria

• Have a current or recent acute, active infection. For at least 30 days before screening and up to Day 1, participants must have no symptoms or signs of confirmed or suspected infection, and must have completed any appropriate anti-infective treatment.
• Have presence of significant uncontrolled respiratory, cerebrocardiovascular, cardiovascular, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or psychiatric disorders, or abnormal laboratory values at screening that, in the opinion of the sponsor or investigator, pose an unacceptable risk to the participant if participating in the study or of interfering with the interpretation of data.
• Are immunocompromised to an extent that participation in the study would pose an unacceptable risk to the participant as determined by the investigator.
• Use or intend to use prescription or nonprescription medication, including dietary supplements, vitamins, herbal supplements, traditional Chinese medicine, or alternative medicines, within 14 days or 5 half-lives (whichever is longer), prior to dosing, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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114 participants in 7 patient groups

LY4268989 or Placebo Cohort 1 (Blinded)

Experimental group

Description:

Participants will receive LY4268989 orally or placebo single dose followed by BID administration

Treatment:

Drug: LY4268989

Drug: Placebo

LY4268989 Cohort 2 (Open-Label)

Experimental group

Description:

Participants will receive LY4268989 orally tablet (formulation compared to capsule formulation) in a fasted state

Treatment:

Drug: LY4268989

LY4268989 Cohort 3 (Open-Label)

Experimental group

Description:

Participants will receive multiple doses of LY4268989 orally BID administration with midazolam orally and intravenously (IV).

Treatment:

Drug: Midazolam

Drug: LY4268989

Drug: Midazolam

LY4268989 or Placebo Cohort 4 (Blinded)

Experimental group

Description:

Participants will receive single escalating doses of LY4268989 orally or placebo

Treatment:

Drug: LY4268989

Drug: Placebo

LY4268989 Cohort 5 (Blinded)

Experimental group

Description:

Participants will receive multiple doses of LY4268989 orally or placebo

Treatment:

Drug: LY4268989

Drug: Placebo

LY4268989 Cohort 6 (Open-Label)

Experimental group

Description:

Participants will receive LY4268989 single dose orally in a fasted and fed state

Treatment:

Drug: LY4268989

LY4268989 Cohort 7 (Open-Label)

Experimental group

Description:

Participants will receive multiple doses of LY4268989 orally BID administration in a fed state

Treatment:

Drug: LY4268989