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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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Have previously completed or withdrawn from this study or any other study investigating LY3509754, and have previously received LY3509754.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

Other trials in United States

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

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 groups in NCT04586920
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.

20 Oct 202014 Oct 2022

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04586920
Acronym / sponsor ID: 17797
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated due to safety findings
Enrolment: 104 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 20 Oct 2020 (actual)
Primary completion: 14 Oct 2022 (actual)
Study completion: 14 Oct 2022 (actual)
First posted: 14 Oct 2020 (actual)
Results: Posted 3 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
LY3509754 - Part A	Experimental	Drug: LY3509754Escalating doses of 10, 30, 100, 300, 1000, and 2000 milligrams (mg) of LY3509754 were administered orally.
Placebo - Part A	Placebo comparator	Drug: PlaceboPlacebo was administered orally.
LY3509754 plus Itraconazole - Part B	Experimental	Drug: LY3509754, Drug: Itraconazole10 mg of LY3509754 and 200 mg of Itraconazole were administered orally.
Placebo plus Itraconazole - Part B	Placebo comparator	Drug: Placebo, Drug: ItraconazolePlacebo and 200 mg Itraconazole were administered orally.
LY3509754 plus Midazolam - Part C	Experimental	Drug: LY3509754, Drug: MidazolamMultiple doses of LY3509754 (100, 300, and 1000 mg) were administered orally. Some participants also received 1.2 mg midazolam orally.
Placebo plus Midazolam - Part C	Placebo comparator	Drug: Placebo, Drug: MidazolamMultiple doses of placebo were administered orally. Some participants also received 1.2 mg midazolam orally.
LY3509754 (Japanese) - Part D	Experimental	Drug: LY3509754Multiple doses of LY3509754 (400 and 1000 mg) were administered orally to Japanese participants.
Placebo (Japanese) - Part D	Placebo comparator	Drug: PlaceboPlacebo was administered orally to Japanese participants.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY3509754Administered orally	Drug	LY3509754 (Japanese) - Part D, LY3509754 - Part A, LY3509754 plus Itraconazole - Part B, LY3509754 plus Midazolam - Part C
PlaceboAdministered orally	Drug	Placebo (Japanese) - Part D, Placebo - Part A, Placebo plus Itraconazole - Part B, Placebo plus Midazolam - Part C
ItraconazoleAdministered orally	Drug	LY3509754 plus Itraconazole - Part B, Placebo plus Itraconazole - Part B
MidazolamAdministered orally	Drug	LY3509754 plus Midazolam - Part C, Placebo plus Midazolam - Part C

Primary outcome

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 Day 26
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.

4 secondary outcomes

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

Results and safety

Results posted to the registry on 3 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A - Placebo (Fasted)	10	10
Part A - Placebo (Fed)	2	2
Part A - 10 Milligram (mg) LY3509754 (Fasted)	6	6
Part A - 30 mg LY3509754 (Fasted)	6	6
Part A - 100 mg LY3509754 (Fasted)	6	6
Part A - 300 mg LY3509754 (Fasted and Fed)	9	9
Part A - 1000 mg LY3509754 (Fasted)	6	5
Part A - 2000 mg LY3509754 (Fasted)	6	4
Part B - Placebo + 200 mg Itraconazole (Day 10)	3	3
Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10)	8	6
Part C - QD [Cohorts 1 and 3]	4	4
Part C - 100 mg LY3509754 QD [Cohort 1]	6	5
Part C - Placebo QD + 1.2 mg Midazolam [Cohort 2]	2	2
Part C - 300 mg LY3509754 QD + 1.2 mg Midazolam [Cohort 2]	8	7
Part C - 1000 mg LY3509754 QD [Cohort 3]	6	6
Part D (Japanese) - Placebo QD	4	4
Part D (Japanese) - 400 mg LY3509754 QD	6	6
Part D (Japanese) - 1000 mg LY3509754 QD	6	6

Primary outcome: 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 Day 26. Count of participants. Unit: Participants

Measure	Part A - Placebo (Fasted) n = 10	Part A - Placebo (Fed) n = 2	Part A - 10 Milligram (mg) LY3509754 (Fasted) n = 6	Part A - 30 mg LY3509754 (Fasted) n = 6	Part A - 100 mg LY3509754 (Fasted) n = 6	Part A - 300 mg LY3509754 (Fasted) n = 9	Part A - 300 mg LY3509754 (Fed) n = 9	Part A - 1000 mg LY3509754 (Fasted) n = 6	Part A - 2000 mg LY3509754 (Fasted) n = 6	Part B - Placebo Alone (Day 1) n = 3	Part B - Placebo + 200 mg Itraconazole (Day 10) n = 3	Part B - 200 mg Itraconazole (Days 4 to 13) n = 11	Part B - 10 mg LY3509754 Alone (Day 1) n = 8	Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10) n = 8	Part C - Placebo QD [Cohorts 1 and 3] n = 4	Part C - 100 mg LY3509754 QD [Cohort 1] n = 6	Part C - 1.2 mg Midazolam (Day -2) [Cohort 2] n = 10	Part C - Placebo QD (Days 1 to 14) [Cohort 2] n = 2	Part C - 300 mg LY3509754 QD (Days 1 to 14) [Cohort 2] n = 8	Part C - Placebo QD + 1.2 mg Midazolam (Day 15) [Cohort 2] n = 2	Part C - 300 mg LY3509754 QD + 1.2 mg Midazolam (Day 15) [Cohort 2] n = 8	Part C - 1000 mg LY3509754 QD [Cohort 3] n = 6	Part D (Japanese) - Placebo QD n = 4	Part D (Japanese) - 400 mg LY3509754 QD n = 6	Part D (Japanese) - 1000 mg LY3509754 QD n = 6
Value	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Population analysed: All participants who received at least one dose of study drug.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to Up To Day 26. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A - Placebo (Fasted)	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Part A - Placebo (Fed)	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Part A - 10 Milligram (mg) LY3509754 (Fasted)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Part A - 30 mg LY3509754 (Fasted)	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Part A - 100 mg LY3509754 (Fasted)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Part A - 300 mg LY3509754 (Fasted)	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Part A - 300 mg LY3509754 (Fed)	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9
Part A - 1000 mg LY3509754 (Fasted)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Part A - 2000 mg LY3509754 (Fasted)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Part B - Placebo Alone (Day 1)	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Part B - Placebo + 200 mg Itraconazole (Day 10)	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Part B - 200 mg Itraconazole (Days 4 to 13)	0 of 11 (0%)	4 of 11 (36.4%)	0 of 11
Part B - 10 mg LY3509754 Alone (Day 1)	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10)	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8
Part C - Placebo QD [Cohorts 1 and 3]	0 of 4 (0%)	1 of 4 (25%)	0 of 4
Part C - 100 mg LY3509754 QD [Cohort 1]	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part C - 1.2 mg Midazolam (Day -2) [Cohort 2]	0 of 10 (0%)	1 of 10 (10%)	0 of 10
Part C - Placebo QD (Days 1 to 14) [Cohort 2]	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Limitations and caveats (from the sponsor): Terminated \[Terminated due to safety findings\].

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38294091Datta-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.
Individual participant dataSharing planned: No

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 Day 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04586920, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.