A Safety, Tolerability and Pharmacokinetic Study of Single and Multiple Doses of LY3526318 in Healthy Participants
- Conditions
- Chronische PijnChronic Pain
- Registration Number
- NL-OMON50998
- Lead Sponsor
- Eli Lilly
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part A: To determine the pharmacokinetics of LY3526318 after a single oral dose<br /><br>administration<br /><br>Part B: To determine the pharmacokinetics of LY3526318 after multiple oral dose<br /><br>administrations</p><br>
- Secondary Outcome Measures
Name Time Method <p>Part A: To estimate the safety and tolerability of LY3526318 after single (Part<br /><br>A) oral administration to healthy participants<br /><br>To evaluate the effect of a meal on the pharmacokinetics of LY3526318 in fed<br /><br>versus fasted conditions<br /><br>Part B: To estimate the safety and tolerability of LY3526318 after multiple<br /><br>oral administrations to healthy participants</p><br>