A Study of LY3526318 in Healthy Participants

Lilly

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: LY3526318; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03977974

J2D-MC-CVAA (Other Identifier)

2019-001902-80 (EudraCT Number)

17426

Details and patient eligibility

About

The main purpose of this study is to learn more about the safety and side effects of LY3526318 when given by mouth to healthy participants. The study will have two parts. Each participant will enroll in only one part. For each participant, Part A will last up to 28 days and Part B will last up to 51 days, including screening and follow-up.

Enrollment: 76 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Part A Cohorts:

- Healthy male participants (including self-reported surgically sterile males) must agree to the following:

• When engaging in sex with Women of Child-Bearing Potential (WOCBP) both the male participant and his female partner must use highly effective contraception consisting of 2 forms of birth control (1 of which must be a male barrier method such as a latex or polyurethane condom) from start of dosing throughout the clinical study period, and for 90 days after the final study drug administration
• Nonsurgically sterile male participants must not donate sperm at any time from start of dosing until 90 days beyond the administration of study drug

All Part A and Part B Cohorts:

• Female participants must be nonpregnant and not lactating, or of nonchildbearing potential (either surgically sterilized [e.g. tubal occlusion, hysterectomy, bilateral salpingectomy] or physiologically incapable of becoming pregnant, or postmenopausal with amenorrhea for at least 12 consecutive months). Healthy female participants of child-bearing potential who have a fertile male sexual partner must be willing and able to practice effective contraception from admission to 30 days after the final visit. Sexually active participants must use a combination of 2 of the following methods of contraception, including at least 1 so-called 'barrier' method:

  • Hormonal contraceptive (oral, transdermal patches, vaginal or injectable)
  • Intrauterine device with or without hormones
  • Condom ('barrier' method)
  • Diaphragm or cervical cap
  • Sexual abstinence

• Have a body mass index 18 to 32 kilograms per square meter (kg/m²)

Exclusion criteria

• Are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
• Have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, convulsions, or any clinically significant laboratory abnormality
• In the opinion of the investigator are considered to be a danger to themselves
• Have an abnormality in the 12-lead electrocardiogram (ECG)
• Have a history of clinically significant multiple or severe drug allergies or severe post treatment hypersensitivity reactions
• Have donated blood of more than 500 milliliter (mL) within the previous month
• Are unwilling to stop alcohol and caffeinated beverage consumption and smoking/use of tobacco while resident in the CRU
• Have an average weekly alcohol intake that exceeds 21 units per week (1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits
• Have an abnormal blood pressure
• Participants with a history of drug abuse
• Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer)
• Are unwilling to comply with the required dietary restrictions

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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76 participants in 4 patient groups, including a placebo group

LY3526318 - Part A

Experimental group

Description:

Single-ascending dose (SAD) 10 milligram (mg), 30 mg, 50 mg, or 300 mg LY3526318 administered orally. 100 mg LY3526318 administered orally without a meal in period 1 and 30 mg LY3526318 administered orally with a meal in period 2. 200 mg LY3526318 administered orally without a meal in period 1 and 200 mg LY3526318 administered orally with a meal in period 2. 100 mg LY3526318 Fed: Period 1: 100 mg LY3526318 administered orally 30 minutes (min) after breakfast (Fed (-30 min.)). Period 2: 100 mg LY3526318 orally 30 minutes before breakfast (Fed (+30 min.)). Period 3: 100 mg LY3526318 administered orally 60 minutes before breakfast (Fed (+60 min.)). Placebo Fed: Period 1: Placebo administered orally 30 minutes after breakfast (Fed (-30 min.)). Period 2: Placebo administered orally 30 minutes before breakfast (Fed (+30 min.)). Period 3: Placebo administered orally 60 minutes before breakfast (Fed (+60 min.)).

Treatment:

Drug: LY3526318

Placebo - Part A

Placebo Comparator group

Description:

Participants received placebo administered orally once.

Treatment:

Drug: Placebo

LY3526318 - Part B

Experimental group

Description:

Multiple-ascending dose (MAD): 30 mg LY3526318 once daily (QD): Participants received 30 mg LY3526318 QD administered orally for 14 days. MAD: 60 mg LY3526318 QD: Participants received 60 mg LY3526318 QD administered orally for 14 days. MAD: 100 mg LY352631 QD: Participants received 100 mg LY3526318 QD administered orally for 14 days.

Treatment:

Drug: LY3526318

Placebo - Part B

Placebo Comparator group

Description:

Participants received placebo QD orally for 14 days.

Treatment:

Drug: Placebo