Phase 1
Completed N=63
A Study of LY3050258 in Healthy Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT02121834 ↗
Enrolled (actual)
63
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
This is a multiple dose study of LY3050258 in healthy men and postmenopausal women. This study will evaluate the safety and how well the body tolerates LY3050258. It will last approximately 14 weeks with a 2 week follow-up appointment after the last treatment with study drug.
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): Area Under the Concentration Curve During One Dosing Interval at Steady State (AUC τ,ss) of Multiple Doses of LY3050258 |
14.5; 24.1; 55.6; 70.0; 84.5 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Concentration (Cmax) of Multiple Doses of LY3050258 |
0.899; 1.35; 3.58; 4.51; 4.99 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy males or healthy postmenopausal females, including Japanese participants
- Body mass index (BMI) of 18 and 35 kilograms per square meter (kg/m^2), inclusive
Exclusion Criteria
- Abnormal siting blood pressure as determined by the investigator
- Abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, places the participant at an unacceptable risk for study participation
- Aspartate aminotransferase (AST) or alkaline phosphatase (ALT) greater than 2 times the upper limit of normal (ULN)
- Skin condition that in the opinion of the investigator makes the participant unsuitable for study participation
- Current use of statins within the last 3 months prior to dosing
- Current use or previous use of anabolic steroids in the preceding 6 months prior to dosing
- Use of dehydroepiandrosterone, other potential over-the-counter 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 (NCT02121834). 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.