Phase 1
Completed N=36
A Study of LY3050258 in Healthy Participants
Healthy Participants
Source: ClinicalTrials.gov NCT01929707 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jul 2018
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 and how well the body will handle a single dose of increasing strength of study drug LY3050258. Each participant will receive LY3050258 or placebo once, in each of 2 dosing periods. At least 7 days will pass between doses. This study will last approximately 45 days for each participant. Screening is required within 28 days before the start of the study.
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 LY3050258 |
0.0397; 0.0626; 0.968; 0.681; 1.77; 0.630 | — |
| SECONDARY PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3050258 |
1.60; 7.02; 17.5; 41.6; 88.5; 23.0 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy males or healthy postmenopausal females, including Japanese participants
- Have a body mass index (BMI) of 18 to 35 kilograms per square meter (kg/m^2)
Exclusion Criteria
- An abnormal sitting blood pressure as determined by the investigator
- Any abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, places the participant at an unacceptable risk for study participation
- Current use of statins within the last 3 months prior to dosing
- Current or previous use of anabolic steroids in the preceding 6 months prior to dosing
- Use of dehydroepiandrosterone, other potential over-the-counter (OTC) steroidal supplements, or other nutritional products intended to have weight-reduction and/or performance-enhancing effects within 21 days prior to dosing
Data sourced from ClinicalTrials.gov (NCT01929707). 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.