Clinical trial NCT07021547: A Study of LY3867070 in Healthy Participants
Official title: A Single- and Multiple-Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of LY3867070 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2025-06-15
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parts A, B, and C are parallel. Part D is open-label fixed-sequence. Part E is crossover.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


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 capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational medicinal product; or of interfering with the interpretation of data
* Have used, or intend to use, prescription or nonprescription medication (including dietary supplements, vitamins, herbal supplements such as St. John's wort, traditional Chinese medicine, or alternative medicines), or any medications known to be strong inhibitors and inducers of the genes CYP1A1, CYP1A2, CYP2B6, CYP3A4 and CYP2C19, within 14 days prior to dosing of any study intervention until end of study assessments are complete
* 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

Primary outcomes:
measure: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline up to Approximately Week 7
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline up to Approximately Week 7
measure: Number of Participants with One or More Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline up to Approximately Week 7
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3867070
timeFrame: Baseline up to Approximately Week 7
measure: PK: Maximum Concentration (Cmax) of LY3867070
timeFrame: Baseline up to Approximately Week 7
measure: Part B Pharmacodynamic (PD): Change from Baseline in CYP1A1 Gene Expression
timeFrame: Baseline up to Approximately Week 6
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Dallas
country: United States
facility: Fortrea Clinical Research Unit
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: