A Study of LY3509754 in Healthy Non-Japanese and Japanese Participants

NCT04586920 | Terminated Phase 1 Results FDA Drug

• 3 other identifiers: 17797J3D-MC-FNAA2020-003957-30
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

Brief Summary

The main purpose of this study in healthy participants is to learn more about the safety of LY3509754 and any side effects that might be associated with it. Blood tests will be performed to check how much LY3509754 gets into the bloodstream and how long it takes the body to eliminate it.

Conditions

Healthy

Outcome Measures

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

  An SAE is any adverse event (AE) from the study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e., immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported here. A summary of SAEs and other non-serious AEs, regardless of causality, will be reported in the Reported Adverse Events module.

  Baseline up to Day 26

Secondary Outcomes (4)

• Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3509754 in Parts A and B

  Part A: Pre-dose (P), 0.5,1,2,3,4,5,6,8,12,16,24,36,48,72,96 hours (h) post Day 1 dose. Part B: P,0.5,1,2,3,4,6,8,12,16,24,36,48,72,96 h post Day 1 dose; P,0.5,1,2,3,4,6,8,12,16,24,36,48,72,96,120,144,168 h Post Day 10 dose.

• PK: Cmax of LY3509754 in Parts C and D

  Part C-Cohorts 1 and 3: P,0.5,1,2,3,4,6,8,12,16,24,48,72,96 h Post Day 14 dose. Part C-Cohort 2: P,0.5,1,2,3,4,5,6,8,12,16,24 h Post Day 14 dose. Part D: P,0.5,1,2,3,4,6,8,12,16,24,48,72,96 h Post Day 14 dose.

• PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours Post-dose AUC(0-24) of LY3509754 in Parts A and B

  Part A: P, 0.5,1,2,3,4,5,6,8,12,16,24 h post Day 1 dose. Part B: P,0.5,1,2,3,4,6,8,12,16,24 h post Day 1 dose; P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 10 dose.

• PK: AUC(0-24) of LY3509754 in Parts C and D

  Part C-Cohorts 1 and 3: P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 14 dose. Part C-Cohort 2: P,0.5,1,2,3,4,5,6,8,12,16,24 h Post Day 14 dose. Part D: P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 14 dose.

Study Arms (8)

LY3509754 - Part A

EXPERIMENTAL

Escalating doses of 10, 30, 100, 300, 1000, and 2000 milligrams (mg) of LY3509754 were administered orally.

Drug: LY3509754

Placebo - Part A

PLACEBO COMPARATOR

Placebo was administered orally.

Drug: Placebo

LY3509754 plus Itraconazole - Part B

EXPERIMENTAL

10 mg of LY3509754 and 200 mg of Itraconazole were administered orally.

Drug: LY3509754; Drug: Itraconazole

Placebo plus Itraconazole - Part B

PLACEBO COMPARATOR

Placebo and 200 mg Itraconazole were administered orally.

Drug: Placebo; Drug: Itraconazole

LY3509754 plus Midazolam - Part C

EXPERIMENTAL

Multiple doses of LY3509754 (100, 300, and 1000 mg) were administered orally. Some participants also received 1.2 mg midazolam orally.

Drug: LY3509754; Drug: Midazolam

Placebo plus Midazolam - Part C

PLACEBO COMPARATOR

Multiple doses of placebo were administered orally. Some participants also received 1.2 mg midazolam orally.

Drug: Placebo; Drug: Midazolam

LY3509754 (Japanese) - Part D

EXPERIMENTAL

Multiple doses of LY3509754 (400 and 1000 mg) were administered orally to Japanese participants.

Drug: LY3509754

Placebo (Japanese) - Part D

PLACEBO COMPARATOR

Placebo was administered orally to Japanese participants.

Drug: Placebo

Interventions

LY3509754 DRUG

Administered orally

LY3509754 (Japanese) - Part D; LY3509754 - Part A; LY3509754 plus Itraconazole - Part B; LY3509754 plus Midazolam - Part C

Placebo DRUG

Administered orally

Placebo (Japanese) - Part D; Placebo - Part A; Placebo plus Itraconazole - Part B; Placebo plus Midazolam - Part C

Itraconazole DRUG

Administered orally

LY3509754 plus Itraconazole - Part B; Placebo plus Itraconazole - Part B

Midazolam DRUG

Administered orally

LY3509754 plus Midazolam - Part C; Placebo plus Midazolam - Part C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overtly healthy males or females, as determined by medical history and physical examination.
• Body mass index (BMI) within the range of 18 to 35 kilograms per meter squared (kg/m²) in Parts A, B, and C. In Part D (Japanese participants), body weight between 50 and 85 kg and BMI within the range of 18 to 28 kg/m².

You may not qualify if:

• Have previously completed or withdrawn from this study or any other study investigating LY3509754, and have previously received LY3509754.
• Women of childbearing potential are excluded from the trial.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Covance Dallas

Dallas, Texas, 75247, United States

Location

Related Publications (1)

• Datta-Mannan A, Regev A, Coutant DE, Dropsey AJ, Foster J, Jones S, Poorbaugh J, Schmitz C, Wang E, Woodman ME. Safety, Tolerability, and Pharmacokinetics of an Oral Small Molecule Inhibitor of IL-17A (LY3509754): A Phase I Randomized Placebo-Controlled Study. Clin Pharmacol Ther. 2024 May;115(5):1152-1161. doi: 10.1002/cpt.3185. Epub 2024 Jan 31.

  PMID: 38294091 DERIVED

MeSH Terms

Interventions

Itraconazole; Midazolam

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Terminated \[Terminated due to safety findings\].

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 14, 2020
• Study Start: October 20, 2020
• Primary Completion: October 14, 2022
• Study Completion: October 14, 2022
• Last Updated: January 3, 2025
• Results First Posted: January 3, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)