A Study of LY3154885 in Healthy Participants

NCT ID: NCT04014361

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-09
• Study Completion Date: 2020-02-09

Brief 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

LY3154885 - Part A

15, 45, 100, 200, 300 or 375 milligrams (mg) LY3154885 administered orally in two of three study periods.

Group Type: EXPERIMENTAL

LY3154885 - Capsule

Intervention Type: DRUG

Administered orally.

Placebo - Part A

Placebo administered orally in one of three study periods.

Group Type: PLACEBO_COMPARATOR

Placebo - Capsule

Intervention Type: DRUG

Administered orally.

45 mg LY3154885 + Itraconazole - Part B

45 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.

Group Type: EXPERIMENTAL

LY3154885 - Capsule

Intervention Type: DRUG

Administered orally.

Itraconazole

Intervention Type: DRUG

Administered orally.

Placebo + Itraconazole - Part B

Placebo 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.

Group Type: PLACEBO_COMPARATOR

Placebo - Capsule

Intervention Type: DRUG

Administered orally.

Itraconazole

Intervention Type: DRUG

Administered orally.

LY3154885 - Part C

Part C was not initiated.

Group Type: EXPERIMENTAL

LY3154885 - Capsule

Intervention Type: DRUG

Administered orally.

Placebo - Part C

Part C was not initiated.

Group Type: PLACEBO_COMPARATOR

Placebo - Capsule

Intervention Type: DRUG

Administered orally.

LY3154885 - Part D

Part D was not initiated.

Group Type: EXPERIMENTAL

LY3154885 - Capsule

Intervention Type: DRUG

Administered orally.

LY3154885 - Tablet

Intervention Type: DRUG

Administered orally.

Interventions

LY3154885 - Capsule

Administered orally.

Intervention Type: DRUG

Placebo - Capsule

Administered orally.

Intervention Type: DRUG

Itraconazole

Administered orally.

Intervention Type: DRUG

LY3154885 - Tablet

Administered orally.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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
• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal 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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Covance

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

J1Z-MC-HUAA

Identifier Type: OTHER

Identifier Source: secondary_id

17051

Identifier Type: -

Identifier Source: org_study_id