A Study of LY3154885 in Healthy Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04014361
• Other study ID #: 17051
• Secondary ID: J1Z-MC-HUAA
• Status: Terminated
• Phase: Phase 1
• Start date: August 9, 2019
• Est. completion date: February 9, 2020

Study information

• Verified date: August 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: February 9, 2020
• Est. primary completion date: February 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3154885 - Capsule
Administered orally.
• Placebo - Capsule
Administered orally.
• Itraconazole
Administered orally.
• LY3154885 - Tablet
Administered orally.

Locations

Country	Name	City	State
United States	Covance	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline through Study Completion (Up to 5 Months)
Secondary	Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154885	Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154885	Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post dose
Secondary	Part B: PK: Maximum Concentration (Cmax) of LY3154885	Part B: PK: Maximum Concentration (Cmax) of LY3154885	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.
Secondary	Part A, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885	Part A, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885	Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post dose
Secondary	Part B, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885		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.
Secondary	Part A, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-8)] of LY3154885	Part A, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-8)] of LY3154885	Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post dose
Secondary	Part B, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-8)] of LY3154885	Part B, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-8)] of LY3154885	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.