Chronische Pijn Chronic Pain
Conditions
Interventions
Part A:
Period 1 Day 1 LY3526318 100 mg or placebo once Fasted
Period 2 Day 1 LY3526318 250 mg or placebo once Fasted
Period 3 Day 1 LY3526318 XX# mg or placebo once Fasted or after high fat
breakfa
Sponsors
Eli Lilly
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years, inclusive. 2. Healthy male participants, as determined through medical history and physical examination. a. A nonvasectomized, male participant must agree to use a condom or abstain from sexual intercourse from start of dosing until 105 days beyond the last dose of study intervention. b. No restrictions are required for a vasectomized male provided his vasectomy has been performed at least 4 months or prior to screening. A male who has been vasectomized *4 months prior to screening must follow the same restrictions as a nonvasectomized male c. Must agree not to donate sperm from start of dosing until 105 days beyond the last dose of study intervention. 3. 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 105 days beyond the last dose of study intervention. Sexually active participants must use a combination of 2 of the following methods of contraception, including at least 1 socalled *barrier* method: a. hormonal contraceptives (oral, transdermal patches, vaginal, or injectable) b. intrauterine device with or without hormones c. condom, diaphragm, or cervical cap (*barrier* method), and d. sexual abstinence. Contraceptive requirements do not apply for participants who are exclusively in a same-sex relationship. Additional guidance is provided in Section 10.4, Appendix 4. 4. Have a body mass index of 18 to 32 kg/m2, inclusive. 5. Are reliable and willing to make themselves available for the duration of the study and are willing to follow CRU-specific study procedures. 6. 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. 7. Capable of giving signed informed consent as described in Section 10.1.2, Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion criteria
Exclusion criteria: 1. 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. 2. Any abnormalities identified following a physical examination of the participant that, in the opinion of the investigator, would jeopardize the safety of the participant or interfere with study conduct if they took part in the study. 3. Positive SARS-CoV-2 virus nasopharyngeal polymerase chain reaction test at Day -1. 4. Contact with SARS-CoV-2-positive or COVID-19 patient within the last 14 days prior to admission to the CRU.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: To determine the pharmacokinetics of LY3526318 after a single oral dose administration Part B: To determine the pharmacokinetics of LY3526318 after multiple oral dose administrations | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A: To estimate the safety and tolerability of LY3526318 after single (Part A) oral administration to healthy participants To evaluate the effect of a meal on the pharmacokinetics of LY3526318 in fed versus fasted conditions Part B: To estimate the safety and tolerability of LY3526318 after multiple oral administrations to healthy participants | — |
Countries
Netherlands
Outcome results
None listed