Phase 1
Completed N=41
A Study of LY3053102 in Healthy Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT01736241 ↗
Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcomePrimary: Number of Participants With One or More Adverse Events (AEs) or Any Serious AEs — 5; 6; 4; 4 participants
Summary
The main purpose of this study was to evaluate the safety and tolerability of the study drug known as LY3053102 in healthy participants. The study also investigated how much of the study drug entered the blood stream and how long it took the body to dispose of the study drug. Information about any side effects that occurred was also collected. The study was expected to last approximately 8 weeks for each participant (up to 4 weeks from screening to the administration of study drug and an additional 4 weeks of follow up).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Adverse Events (AEs) or Any Serious AEs |
5; 6; 4; 4; 6; 5 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3053102 |
7.24; 16.1; 94.0; 192; 481; 1810 | — |
| SECONDARY PK: Observed Maximum Drug Concentration (Cmax) of LY3053102 |
0.0693; 0.140; 0.784; 1.68; 4.49; 16.2 | — |
| SECONDARY Number of Participants Who Developed Anti-LY3053102 Antibodies |
0; 1; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Normal blood pressure
- Female participants were not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause
- Had a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m^2), inclusive, at screening
Exclusion Criteria
- Had known allergies to LY3053102 or related compounds
- Had a history of significant disease that may have affected the actions of drugs or may pose a risk when taking the study medication
- Had a history of developing allergies, asthma, severe drug allergies (symptoms including, but not limited to, itching, red rashes, sores on the skin, scaling and shedding of skin), allergies or reactions to more than one drug, or have had bad reactions to skin creams containing corticosteroids
- Heavy smokers (more than 10 cigarettes a day)
Data sourced from ClinicalTrials.gov (NCT01736241). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.