Healthy Volunteers Clinical Trial
Official title:
Safety, Tolerability, and Pharmacokinetics of Multiple Novel Insulin Lispro Formulations
| Verified date | September 2015 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Singapore: Health Sciences Authority |
| Study type | Interventional |
The purposes of this study are to determine:
- Part A
- How quickly your body absorbs, breaks down and gets rid of the different
formulations of insulin lispro compared to insulin lispro alone formulation.
- The safety of insulin lispro in different formulations and any side effects that
might be associated with it.
- Part B:
- How much insulin lispro from different dose ranges is found in the bloodstream
using a test insulin lispro formulation (selected from Part A).
- The safety of insulin lispro in different formulations and any side effects that
might be associated with it.
Participants may only enroll in one part. The study is expected to last up to 10 weeks for
each part.
| Status | Completed |
| Enrollment | 54 |
| Est. completion date | September 2015 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 21 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Overtly healthy males or females (nonchildbearing potential and with absent cyclical hormonal changes), as determined by medical history and physical examination Exclusion Criteria: - Have a fasting plasma glucose less than or equal to (=) 4.0 millimole per liter (mmol/L) at screening |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Singapore | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Singapore |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
Singapore,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Part A and B: Pharmacokinetics: Area Under The Concentration Curve (AUC) of LY275585 | Predose through day 1 in each period | No |
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