Chronic pain chronic pain
Conditions
Interventions
LY3526318 or placebo will be given once (in Group 3 [women only] and Group 4
once per period) / once daily for 14 days as oral capsule(s) with 240
milliliters (mL) of water.
In Groups 3 and 4, all
Sponsors
Eli Lilly
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety/tolerability: AE/SAEs | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma PK: AUC, Cmax, Tmax | — |
Countries
Netherlands
Outcome results
None listed