Overview

This trial is active, not recruiting.

Condition healthy volunteers
Treatments ly3050258, placebo
Phase phase 1
Sponsor Eli Lilly and Company
Start date June 2014
End date December 2014
Trial size 120 participants
Trial identifier NCT02121834, 14936, I6R-MC-DLAB

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose basic science
Arm
(Experimental)
Daily dose of LY3050258 for 28 days.
ly3050258
placebo
(Placebo Comparator)
Daily dose of placebo matching LY3050258 for 28 days.
ly3050258
placebo

Primary Outcomes

Measure
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
time frame: Baseline to study completion (approximately 14 weeks)

Secondary Outcomes

Measure
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Multiple Doses of LY3050258
time frame: Baseline through 4 weeks
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Multiple Doses of LY3127760
time frame: Baseline through 4 weeks

Eligibility Criteria

Male or female participants from 30 years up to 80 years old.

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

Additional Information

Official title A Multiple-Dose, Dose Escalation, Safety, Tolerability, and Pharmacokinetic Study of LY3050258
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.