HealthyPhase 1NCT04586920
A Study of LY3509754 in Healthy Non-Japanese and Japanese Participants
A Phase 1 study testing LY3509754, Itraconazole and Midazolam in people with Healthy, run by Eli Lilly and Company at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3509754, Itraconazole and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Oct 2020to 14 Oct 2022
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Have previously completed or withdrawn from this study or any other study investigating LY3509754, and have previously received LY3509754.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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Covance Dallas
Dallas, Texas, 75247
About this study
Official title: A Phase 1, Randomized, Participant-and Investigator-Blind, Placebo-Controlled, Single-and Multiple-Ascending Dose, Drug-Drug Interaction and Food Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3509754 in Healthy Non-Japanese and Japanese Participants
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
- Being tested
- LY3509754, Placebo, Itraconazole, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3509754Drug
Administered orally
PlaceboDrug
Administered orally
ItraconazoleDrug
Administered orally
MidazolamDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| LY3509754 - Part A | Experimental | Escalating doses of 10, 30, 100, 300, 1000, and 2000 milligrams (mg) of LY3509754 were administered orally. Receives: Drug: LY3509754 |
| Placebo - Part A | Placebo comparator | Placebo was administered orally. Receives: Drug: Placebo |
| LY3509754 plus Itraconazole - Part B | Experimental | 10 mg of LY3509754 and 200 mg of Itraconazole were administered orally. Receives: Drug: LY3509754; Drug: Itraconazole |
| Placebo plus Itraconazole - Part B | Placebo comparator | Placebo and 200 mg Itraconazole were administered orally. Receives: 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. Receives: 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. Receives: Drug: Placebo; Drug: Midazolam |
| LY3509754 (Japanese) - Part D | Experimental | Multiple doses of LY3509754 (400 and 1000 mg) were administered orally to Japanese participants. Receives: Drug: LY3509754 |
| Placebo (Japanese) - Part D | Placebo comparator | Placebo was administered orally to Japanese participants. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to Day 26
Secondary outcomes (4)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3509754 in Parts A and B
PK: Cmax of LY3509754 in Parts A and B.
Measured: 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
PK: Cmax of LY3509754 in Parts C and D.
Measured: 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
PK: AUC(0-24) of LY3509754 in Parts A and B.
Measured: 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
PK: AUC(0-24) of LY3509754 in Parts C and D.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start20 Oct 2020
- Primary completion14 Oct 2022
- Study completion14 Oct 2022
Why it stopped: Terminated due to safety findings
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586920
- Sponsor's protocol ID
- 17797
- Other IDs
- J3D-MC-FNAA, 2020-003957-30
- Status last verified
- Nov 2024
- First submitted
- 13 Oct 2020
- Last updated
- 3 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38294091