A Safety, Tolerability, Pharmacokinetic, and Pilot Food Effect Study of Single- and Multiple-Ascending Doses of LY3526318 in Healthy Participants
- Conditions
- Chronic painchronic pain
- Registration Number
- NL-OMON48109
- Lead Sponsor
- Eli Lilly
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 84
1. Aged 18 to 65 years, inclusive.
Part A, Cohorts 10, 50 and 100 mg (this includes males and females, males
participate in cohorts up to 100mg):
2. Healthy male participants (including self-reported surgically sterile
males), as determined through medical history and physical examination, must
agree to the following:
a. When engaging in sex with a 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.
b. 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: 10, 50, 100, 400, 800, 1000mg (females are
allowed to participate in all cohorts):
3. 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). Nonpregnancy will be confirmed for all female participants through a
serum pregnancy test at screening and at admission to the CRU and at a final
study visit. Follicle-stimulating hormone will be tested at screening for all
female participants.
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:
a. Hormonal contraceptive (oral, transdermal patches, vaginal or injectable)
b. Intrauterine device with or without hormones
c. Condom (*barrier* method)
d. Diaphragm or cervical cap
e. Sexual abstinence
Contraceptive requirements do not apply for participants who are exclusively in
same-sex relationships.
4. Have a body mass index 18 to 32 kg/m2.
5. Have given informed consent prior to any study-specific procedures.
6. Are reliable and willing to make themselves available for the duration of
the study and are willing to follow CRU-specific study procedures.
7. Have clinical laboratory test results within normal reference range for the
population or CRU, or results with acceptable deviations that are judged not
clinically significant by the investigator.
1. 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.
2. Have previously completed or withdrawn from this study or any other study
investigating this study drug.
3. 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 that, in the judgment of the investigator, indicate a medical
problem that would preclude study participation.
4. In the opinion of the investigator are considered to be a danger to
themselves, or who have answered *yes* to either Question 4 or Question 5 on
Suicidal Ideation portion of the Columbia-Suicide Severity Rating Scale
(C-SSRS); or answered yes to any of the suicide-related behaviors on the
Suicidal Behavior portion of C-SSRS; and the ideation and behavior occurred
within the past 6 months
5. Have an abnormality in the 12-lead ECG that, in the opinion of the
investigator, increases the risks associated with participating in the study.
In addition, participants with the following findings will be excluded:
a. confirmed Frederica*s corrected QT interval >450 msec for men and >470 msec
for women. One repeat ECG may be performed if required.
6. Have a history of clinically significant multiple or severe drug allergies
or severe posttreatment hypersensitivity reactions, which in the opinion of the
investigator may hamper participation in the study.
7. Are an investigator or CRU personnel directly affiliated with this study, or
are immediate family members of investigator or CRU personnel. Immediate family
is defined as a spouse, parent, child or sibling, whether biological or legally
adopted.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety/tolerability: AE/SAEs</p><br>
- Secondary Outcome Measures
Name Time Method <p>Plasma PK: AUC, Cmax, Tmax</p><br>