A Study of LY2605541 in Healthy Participants and in the Elderly
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/18/2018 |
Start Date: | March 2013 |
End Date: | July 2013 |
Effect of Injection Site on the Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Doses of LY2605541 in Healthy Subjects, and Impact of Body Mass Index and Age on the Pharmacokinetics of LY2605541
This study will include 2 groups (cohorts) of participants:
In Cohort A, this study will look at the amount of LY2605541 that is present in the body
after it is injected in 3 different locations in the body of the same participant. At least
16 days will pass between each injection.
In Cohort B, the study will look at how the body absorbs, distributes, and disposes of
LY2605541 in participants aged 65 and over.
Participants may enroll in only one cohort.
In Cohort A, this study will look at the amount of LY2605541 that is present in the body
after it is injected in 3 different locations in the body of the same participant. At least
16 days will pass between each injection.
In Cohort B, the study will look at how the body absorbs, distributes, and disposes of
LY2605541 in participants aged 65 and over.
Participants may enroll in only one cohort.
Inclusion Criteria:
- Cohort A: are overtly healthy male or female participants, as determined by medical
history and physical examination, aged ≥18 to ≤55 years of age
- Cohort B: are male or female elderly (≥65 years of age) participants that are overtly
healthy, or have stable, chronic medical conditions (including Type 2 Diabetes
Mellitus [T2DM]) that, in the investigator's opinion, will not significantly alter the
disposition of the drug, will not place the participant at increased risk by
participating in the study, and will not interfere with interpretation of the data
- Male participants agree to use a reliable method of birth control during the study and
for 3 months following the last dose of the investigational product
- Female participants are women of child-bearing potential who test negative for
pregnancy at the time of screening based on a urine pregnancy test and agree to use a
reliable method of birth control during the study and for 1 month following the last
dose of the investigational product
- Female participants are post-menopausal women, or women not of child-bearing potential
due to surgical sterilization (at least 3 months after surgical hysterectomy, or at
least 3 months after bilateral oophorectomy or bilateral tubal ligation/occlusion with
or without hysterectomy) confirmed by medical history, or menopause
- Have a body mass index (BMI) of 18.5 to 40 kilogram per meter square (kg/m^2),
inclusive, at time of admission for Period 1
- Have given written informed consent approved by Lilly and the ethical review board
(ERB) governing the site
Exclusion Criteria:
- Are participants that intend to start a change in diet or lose weight during the
study; participants will be expected to maintain their approximate current weight
throughout the study
- Are excessive smokers (>10 cigarettes per day); participants who smoke ≤10 cigarettes
per day must be able to stop smoking while residing at the clinical research unit
(CRU)
Healthy Participants - Cohort A
- Have Type 1 Diabetes Mellitus (T1DM), Type 2 Diabetes Mellitus (T2DM), or a fasting
blood glucose (BG) >110 milligrams per deciliter (mg/dL) (6.1 millimoles per liter
[mmol/L]) with a glycated hemoglobin (HbA1c) of >6.2%
- Intend to use over-the-counter medication within the 7 days or prescription medication
within 14 days prior to dosing (apart from contraceptive medication, vitamin/mineral
supplements, occasional paracetamol, thyroxine replacement therapy, and hormone
replacement therapy). Antihypertensive and lipid lowering agents are permitted, but
must have been administered at stable dose(s) for at least 1 month.
Elderly Participants - Cohort B
- Have T1DM
- Are T2DM participants that require insulin treatment, or have a HbA1c of >10%
- Have started new chronic medication(s) or changed the dose of an existing chronic
medication <1 month prior to dosing. Participants are permitted to continue ongoing
chronic medications (for example antihypertensive agents, aspirin, non-steroidal
anti-inflammatory drugs, lipid lowering agents, thyroxine, hormone replacement
therapy, and/or oral anti-diabetic if participants have T2DM). Other stable chronic
conditions may be permitted if deemed acceptable by the investigators and Lilly
clinical pharmacologist or clinical research physician.
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