Phase 1 Completed N=77 Randomized Double-blind Basic Science

A Study of LY3127760 in Healthy Participants

Healthy Volunteers

Source: ClinicalTrials.gov NCT01968070 ↗

Enrolled (actual)

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 purposes of this study are to evaluate the safety and how well the body handles single and multiple doses of increasing strength of study drug, LY3127760. This study includes three parts. Part 3 may be initiated at sponsor's discretion, based on data from Part 2. Participants will only enroll in 1 of the 3 study parts. This study will last approximately 7 to 13 weeks, depending on part. Screening must be completed within 28 days prior to enrollment.

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 Versus Time Curve From Zero to Infinity (AUC 0-∞) of Single Dose LY3127760	NA; 3010; 17200; 40000; 47400; 71900	—
SECONDARY PK: Maximum Observed Concentration (Cmax) of Single Dose LY3127760	264; 890; 3880; 10300; 18900; 21600	—
SECONDARY PK: Time of Maximum Observed Concentration (Tmax) of Single Dose LY3127760	2.00; 2.00; 2.00; 2.00; 1.00; 1.50	—
SECONDARY PK: Area Under the Concentration Versus Time Curve During One Dosing Interval [AUC-tau (τ)] of Multiple Doses LY3127760	1020; 4350; 11300; 19700	—
SECONDARY PK: Cmax of Multiple Doses LY3127760	301; 1210; 3650; 6170	—
SECONDARY PK: Tmax of Multiple Doses LY3127760	2.00; 1.65; 2.00; 2.00	—

Eligibility Criteria

Inclusion Criteria

Overtly healthy males or females as determined by medical history and physical examination
Male participants agree to use a reliable method of birth control during the study and 3 months following the last dose of the investigational product
Female participants not of child-bearing potential
Have a body mass index of 18.5 to 32 kilograms per square meter (kg/m^2) inclusive
Are normotensive (defined as supine systolic blood pressure [BP] less than 140 millimeters of mercury [mm Hg] and diastolic BP less than 90 mm Hg) without use of any antihypertensives

Exclusion Criteria

Have known allergies to LY3127760, related compounds or any components of the formulation, celecoxib or sulfonamides, or history of significant atopy. Participants with known aspirin allergy or allergic reactions to nonsteroidal anti-inflammatory drugs (NSAIDs) should also be excluded
Have any current or prior history of a significant gastrointestinal illness such as peptic ulcer disease, gastrointestinal (GI) bleeding, chronic gastritis, inflammatory bowel disease or chronic diarrhea
Have evidence of other chronic liver disease, including but not limited to chronic alcoholic disease, nonalcoholic steatohepatitis, recent history (within 3 months of screening) of acute viral hepatitis or chronic autoimmune hepatitis
Have used any NSAIDs, celecoxib, aspirin or acetaminophen (at doses greater than 1 gram per day), anticoagulants or antiplatelet agents within 14 days of admission

Part 2 and Part 3 only

Have 1 plus pretrial pitting edema or 2 plus ankle or pedal edema

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Data sourced from ClinicalTrials.gov (NCT01968070). 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.