A Study of LY3867070 in Healthy Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LY3867070, Placebo.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single- and Multiple-Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of LY3867070 in Healthy Participants
Overview
The purpose of this study is to evaluate how well LY3867070 is tolerated and what side effects may occur in healthy participants. The study drug will be administered orally. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.
Interventions
- Drug LY3867070
Administered orally - Drug Placebo
Administered orally
Primary outcome measures
- Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) Considered by the Investigator to be Related to Study Drug Administration [Time frame: Baseline up to Approximately Week 7]
- 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 Approximately Week 7]
- Number of Participants with One or More Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration [Time frame: Baseline up to Approximately Week 7]
Secondary outcome measures (3)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3867070 [Time frame: Baseline up to Approximately Week 7]
- PK: Maximum Concentration (Cmax) of LY3867070 [Time frame: Baseline up to Approximately Week 7]
- Part B Pharmacodynamic (PD): Change from Baseline in Gene Expression [Time frame: Baseline up to Approximately Week 6]
Eligibility criteria
Inclusion criteria
- Are overtly healthy as determined by medical evaluation
- Part C of the study includes only Japanese and Chinese participants
- Have a body weight greater than or equal to 45 kilogram (kg) and also body mass index 18 to 32 kilogram per square meter (kg/m²) inclusive
Exclusion criteria
- Have a history or presence of multiple or severe allergies, anaphylactic reaction to prescription or nonprescription drugs, or history of significant atopy
- Have a significant history or current thyroid disease
- Have a significant history of or current psychiatric disorders, rheumatologic, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (such as Cushing syndrome and hyperaldosteronism), hematological, or neurological disorders
- Are smokers (including electronic cigarettes) within 6 months prior to screening and unwilling to refrain from smoking for the duration of the study.
- Unwilling to undergo skin biopsies (for Part B only)
- Are unwilling to have body hair cut or shaved in cases where hair, in the investigator's opinion, could interfere with noninvasive skin patch
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 2 centers
- Anaheim Clinical Trials, LLC — Anaheim
- Fortrea Clinical Research Unit — Dallas
Identifiers
NCT: NCT07021547 · 18873 · J5H-MC-KVAA