Phase 1
Completed N=45
A Study of LY2951742 in Healthy Japanese and Caucasian Participants
Migraine Disorders
Source: ClinicalTrials.gov NCT02104765 ↗
Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — 0; 0; 0; 0 Participants
Summary
The main purpose of this study is to evaluate the safety of the study drug known as LY2951742 in healthy Japanese and Caucasians. The study will also investigate how the body processes the drug and how the drug affects the body. The study is expected to last about 5 to 7 months, depending on the arm.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2951742 |
775; 4270; 18000; 41400; 36300 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Curve, Zero to Infinity ( AUC[0-∞]) |
27600; 173000; 733000; 1520000; 757000 | — |
Eligibility Criteria
Inclusion Criteria
- Participants are either Caucasian or first generation Japanese.
- Participants' body mass index (BMI) is between 18.0 and 35.0 kilogram per meter square (kg/ m^2).
Exclusion Criteria
- Participants are heavy caffeine drinkers defined by regular intake of more than 5 cups of coffee (or equivalent in xanthine containing beverages) per day, and/or are unable or unwilling to abide by caffeine restrictions as specified in the protocol.
- Participants are smoking within the previous 6 months.
- Participants have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) prior to dosing or have received a vaccination within 1 month.
- Participants have known allergies to LY2951742, related compounds or any components of the formulation, or history of significant atopy.
- Participants are allergies to either humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone.
Data sourced from ClinicalTrials.gov (NCT02104765). 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.