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HealthyPhase 1NCT05602675

A Drug Interaction Study of LY3871801 in Healthy Participants

A Phase 1 study testing LY3871801, Methotrexate and Warfarin in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main purpose of this study is to determine the effect of LY3871801 when administered orally on the levels of methotrexate (part 1), drug cocktail (warfarin, dextromethorphan, and midazolam) and repaglinide (part 2) in the blood stream when administered orally in healthy participants. 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?
LY3871801, Methotrexate and Warfarin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
2 Nov 2022to 29 Mar 2023
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Participants who are overtly healthy as determined by medical evaluation including medical history and physical examination.
  • Have body weight ≥ 45 kilograms (kg) and body mass index (BMI) within the range 18.5 to 40.0 kilograms per meter squared (kg/m²)
  • Male or female participants not of childbearing potential (both parts) and for part 2, female participants of child bearing potential are eligible.

Who cannot join

  • Have known allergies to LY3871801, related compounds, or any components of the formulation, or history of significant atopy.
  • Have known allergies to drugs including methotrexate, folic acid, repaglinide, warfarin, dextromethorphan, and midazolam that would pose an unacceptable risk to the participant.
  • Have an abnormal blood pressure and/or pulse rate, deemed to be clinically significant by the investigator
  • Have used or intend to use prescription or nonprescription medication
  • Have a positive (not indeterminate) QuantiFERON®-TB Gold test

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Covance Dallas

    Dallas, Texas, 75247

Other trials in United States

About this study

Official title: Evaluation of the Effect of LY3871801 on the Pharmacokinetics of CYP450 Substrates and an OAT1/3 Substrate in Healthy Participants

The main purpose of this study is to determine the effect of LY3871801 when administered orally on the levels of methotrexate (part 1), drug cocktail (warfarin, dextromethorphan, and midazolam) and repaglinide (part 2) in the blood stream when administered orally in healthy participants. The information about any adverse effects experienced will be collected and the tolerability of LY3871801 will also be evaluated. The study may last up to approximately 25 days for each participant.

Conditions
Healthy
Being tested
LY3871801, Methotrexate, Warfarin, Dextromethorphan, Midazolam

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3871801Drug

    Administered orally.

  • MethotrexateDrug

    Administered orally.

  • WarfarinDrug

    Administered orally.

  • DextromethorphanDrug

    Administered orally.

  • MidazolamDrug

    Administered orally.

  • RepaglinideDrug

    Administered orally.

Study groups in NCT05602675
Study groupRoleWhat they receive
LY3871801 + Methotrexate (Part 1)ExperimentalLY3871801 administered orally in combination with methotrexate given orally.
Receives: Drug: LY3871801; Drug: Methotrexate
LY3871801 + Repaglinide + Drug Cocktail (Part 2)ExperimentalLY3871801 administered orally in combination with repaglinide given orally and drug cocktail which includes warfarin, dextromethorphan and midazolam administered orally.
Receives: Drug: LY3871801; Drug: Warfarin; Drug: Dextromethorphan; Drug: Midazolam; Drug: Repaglinide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Methotrexate

    Part 1: PK: Cmax of Methotrexate

    Measured: Predose up to 48 hours postdose

  2. Part 1: PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Methotrexate

    Part 1: PK: AUC[0-∞] of Methotrexate

    Measured: Predose up to 48 hours postdose

  3. Part 2: PK: Cmax of Midazolam

    Part 2: PK: Cmax of Midazolam

    Measured: Predose up to 24 hours postdose

  4. Part 2: PK: AUC[0-∞] of Midazolam

    Part 2: PK: AUC[0-∞] of Midazolam

    Measured: Predose up to 24 hours postdose

  5. Part 2: PK: Cmax of S-warfarin

    Part 2: PK: Cmax of S-warfarin

    Measured: Predose up to 96 hours postdose

  6. Part 2: PK: AUC[0-∞] of S-warfarin

    Part 2: PK: AUC[0-∞] of S-warfarin

    Measured: Predose up to 96 hours postdose

  7. Part 2: PK: Cmax of Dextromethorphan

    Part 2: PK: Cmax of Dextromethorphan

    Measured: Predose up to 72 hours postdose

  8. Part 2: PK: AUC[0-∞] of Dextromethorphan

    Part 2: PK: AUC[0-∞] of Dextromethorphan

    Measured: Predose up to 72 hours postdose

  9. Part 2: PK: Cmax of Repaglinide

    Part 2: PK: Cmax of Repaglinide

    Measured: Predose up to 24 hours postdose

  10. Part 2: PK: AUC[0-∞] of Repaglinide

    Part 2: PK: AUC[0-∞] of Repaglinide

    Measured: Predose up to 24 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2022
  2. Study start2 Nov 2022
  3. Primary completion29 Mar 2023
  4. Study completion29 Mar 2023

Resources

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05602675
Sponsor's protocol ID
18336
Other IDs
J3P-MC-FTAD
Status last verified
Apr 2023
First submitted
28 Oct 2022
Last updated
18 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3871801, Methotrexate and Warfarin in people with Healthy, run by Eli Lilly and Company at 1 site 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Part 1: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Methotrexate (time frame: Predose up to 48 hours postdose). The study lists 10 primary outcomes in all. 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 NCT05602675.

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 18 Apr 2023.

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