Health TrialsbyHealthPanel

A Study of LY4355756 in Healthy Participants

ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEli Lilly and Company

About this trial

The purpose of the study is to assess how LY4355756 is absorbed by the body and how safe it is to healthy participants.

There will be four inpatient stays at the clinical research unit (CRU). For Part A there will be 5 continuous days, Part B 22 continuous days, Part C 5 continuous days in each of the 3 periods, and Part D 18 continuous days in the CRU.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, electrocardiogram (ECGs), and vital signs

Have a body mass index within the range 18.0-32.0 kilograms per square meter (kg/m²) (inclusive)

Individuals assigned male at birth (AMAB) or assigned female at birth (AFAB)

Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Disqualifiers

Have presence of significant uncontrolled respiratory, cerebrocardiovascular, cardiovascular, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or psychiatric disorders, or abnormal laboratory values at screening

Have an abnormality in 12-lead ECG at screening that, in the opinion of the investigator, may increase the risk associated with participating in the study or may confound ECG data analysis

Have a diagnosis or history of malignancy within 5 years prior to screening

basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years

Trial design

Design model

Parallel

Treatments tested in this trial

  • LY4355756

    Drug

    Administered orally as capsule

  • LY4355756

    Drug

    Administered orally as tablet

  • Midazolam

    Drug

    Administered orally as liquid

Treatment groups

123 Participants
are divided into 5 treatment groups
Group A: LY4355756 Part AExperimental treatment 1 intervention
Group B: LY4355756 Part BExperimental treatment 1 intervention
Group C: LY4355756 Part CExperimental treatment 1 intervention
Group D: LY4355756 + Midazolam Part DExperimental treatment 2 interventions
Group E: Midazolam Part DExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame
Baseline up to the Safety Follow up Visit (6 months)
2

Number of Participants with One or More Treatment-Emergent Adverse Event(s) (TEAEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame
Baseline up to the Safety Follow up Visit (6 months)

Secondary outcomes

1

Pharmacokinetics (PK): Area Under the Curve (AUC) of LY4355756

Time frame
Baseline up to Day 18
2

PK: Maximum Plasma Concentration (Cmax) of LY4355756

Time frame
Baseline up to Day 18
3

PK: AUC of Midazolam

Time frame
Baseline up to Day 14
4

PK: Cmax of Midazolam

Time frame
Baseline up to Day 14

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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