Clinical trial NCT03977974: A Study of LY3526318 in Healthy Participants
Official title: A Safety, Tolerability, Pharmacokinetic, and Pilot Food Effect Study of Single- and Multiple-Ascending Doses of LY3526318 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-06-06
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through Study Completion (Part A: Day 38; Part B: Day 51)
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3526318
timeFrame: Part A: Predose on Day 1 through Day 3; Part B: Predose on Day 1 through Day 15
measure: PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
timeFrame: Part A: Predose on Day 1 through Day 3; Part B: Predose on Day 1 through Day 15
measure: PK: Time to Cmax (Tmax) of LY3526318
timeFrame: Part A: Predose on Day 1 through Day 3; Part B: Predose on Day 1 through Day 15
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: