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HealthyPhase 1NCT04014361

A Study of LY3154885 in Healthy Participants

A Phase 1 study testing LY3154885 - Capsule, Itraconazole and LY3154885 - Tablet in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

Terminated

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

Official record
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Trial summary

The main purpose of this study is to learn more about the safety and side effects of LY3154885 when given by mouth to healthy participants. The study will have up to four parts. Each participant will enroll in only one part. The study will last up to 70 days for each participant, including screening and follow-up. Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
LY3154885 - Capsule, Itraconazole and LY3154885 - Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteUnited States
Study dates
9 Aug 2019to 9 Feb 2020
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 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Are overtly healthy males or females, as determined by medical history and physical examination
  • Male participants:
  • Men, regardless of their fertility status, with partners who are nonpregnant women of childbearing potential, must agree to either remain abstinent (if this is their preferred and usual lifestyle) or use condoms with spermicide as well as 1 additional highly effective (<1% failure rate) method of contraception or effective method of contraception (such as diaphragms with spermicide) for 3 months following dosing
  • Men with pregnant partners should use condoms with spermicide during intercourse for the duration of the study or for 3 months following dosing, whichever is longer
  • Men who are in exclusively same-sex relationships (as their preferred and usual lifestyle) or with female partners of non-childbearing potential are not required to use contraception
  • Men should refrain from sperm donation for the duration of the study or for 3 months following the last dose of study drug, whichever is longer
Show all 15Show fewer
  • Female participants of non-childbearing potential, including those who are:
  • Infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, bilateral salpingectomy, confirmed tubal ligation, or tubal occlusion) or congenital anomaly such as Müllerian agenesis; or
  • Postmenopausal, defined as 1 of the following:
  • A woman at least 50 years of age with an intact uterus, not on hormone replacement therapy, who has had either:
  • Cessation of menses for at least 1 year; or
  • At least 6 months of spontaneous amenorrhea with a follicle-stimulating hormone level ≥40 milli-international units per milliliter (mIU/mL) at screening
  • A woman at least 55 years of age, not on hormone replacement therapy, who has had at least 6 months of spontaneous amenorrhea; or
  • A woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy
  • Have a body mass index (BMI) of 18.0 to 35.0 kilograms per square meter (kg/m²), inclusive

Who cannot join

  • Have a marked baseline prolongation of/corrected QT (QTc) interval (for example, repeated demonstration of a QTcB interval >450 milliseconds [msec] for males or >470 msec for females);
  • A history of additional risk factors for Torsades de Pointes (for example, heart failure, hypokalemia, family history of Long QT Syndrome);
  • The use of concomitant medications that prolong the QT/QTc interval
  • Have an abnormal blood pressure (BP) (taken after the participant has been in a supine position for at least 5 minutes) for the population, as determined by a systolic BP >140 millimeters of mercury (mmHg) or a diastolic BP >90 mmHg at screening or a preexisting history of hypertension. Up to 2 additional measurements may be taken after an appropriate resting interval at screening to confirm eligibility
  • Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (such as Cushing syndrome, hyperthyroidism, 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 (IMP); or of interfering with the interpretation of data
  • Have a history of or current significant psychiatric disorders

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Covance

    Dallas, Texas, 75247

Other trials in United States

About this study

Official title: Single- and Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study With LY3154885 in Healthy Subjects

The main purpose of this study is to learn more about the safety and side effects of LY3154885 when given by mouth to healthy participants. The study will have up to four parts. Each participant will enroll in only one part. The study will last up to 70 days for each participant, including screening and follow-up.

Conditions
Healthy
Being tested
LY3154885 - Capsule, Placebo - Capsule, Itraconazole, LY3154885 - Tablet

What participants receive

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

  • LY3154885 - CapsuleDrug

    Administered orally.

  • Placebo - CapsuleDrug

    Administered orally.

  • ItraconazoleDrug

    Administered orally.

  • LY3154885 - TabletDrug

    Administered orally.

Study groups in NCT04014361
Study groupRoleWhat they receive
LY3154885 - Part AExperimental15, 45, 100, 200, 300 or 375 milligrams (mg) LY3154885 administered orally in two of three study periods.
Receives: Drug: LY3154885 - Capsule
Placebo - Part APlacebo comparatorPlacebo administered orally in one of three study periods.
Receives: Drug: Placebo - Capsule
45 mg LY3154885 + Itraconazole - Part BExperimental45 mg LY3154885 administered orally in period 1 followed by 200 mg Itraconazole administered orally on 10 consecutive days and then 45 mg LY3154885 co-administered with 200 mg itraconazole orally during period 2.
Receives: Drug: LY3154885 - Capsule; Drug: Itraconazole
Placebo + Itraconazole - Part BPlacebo comparatorPlacebo administered orally during period 1 followed by 200 mg Itraconazole administered orally on 10 consecutive days and then placebo co-administered with 200 mg itraconazole orally during period 2.
Receives: Drug: Placebo - Capsule; Drug: Itraconazole
LY3154885 - Part CExperimentalPart C was not initiated.
Receives: Drug: LY3154885 - Capsule
Placebo - Part CPlacebo comparatorPart C was not initiated.
Receives: Drug: Placebo - Capsule
LY3154885 - Part DExperimentalPart D was not initiated.
Receives: Drug: LY3154885 - Capsule; Drug: LY3154885 - Tablet

What is being measured

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

  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 AE from this study that results in one of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, 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 one of the other outcomes listed in the definition above. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.

    Measured: Baseline through Study Completion (Up to 5 Months)

Secondary outcomes (6)

  1. Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154885

    Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154885

    Measured: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post dose

  2. Part B: PK: Maximum Concentration (Cmax) of LY3154885

    Part B: PK: Maximum Concentration (Cmax) of LY3154885

    Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post dose; Day 14: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72 and 96 hours post dose.

  3. Part A, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885

    Part A, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885

    Measured: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post dose

  4. Part B, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885

    Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post dose; Day 14: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72 and 96 hours post dose.

  5. Part A, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY3154885

    Part A, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY3154885

    Measured: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post dose

  6. Part B, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY3154885

    Part B, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY3154885

    Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post dose; Day 14: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72 and 96 hours post dose.

Timeline

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

  1. First posted10 Jul 2019
  2. Study start9 Aug 2019
  3. Primary completion9 Feb 2020
  4. Study completion9 Feb 2020

Why it stopped: HUAA study is terminated early due to a business decision.

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
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04014361
Sponsor's protocol ID
17051
Other IDs
J1Z-MC-HUAA
Status last verified
Aug 2023
First submitted
9 Jul 2019
Last updated
12 Mar 2024
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 LY3154885 - Capsule, Itraconazole and LY3154885 - Tablet 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 15 inclusion and 6 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 12 Mar 2024. 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. 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 12 Mar 2024). 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 through Study Completion (Up to 5 Months)). 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 NCT04014361.

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 12 Mar 2024.

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