A Study of LY3127760 in Healthy Participants

NCT01968070 | Completed Phase 1 Results

• 2 other identifiers: 15181I7A-MC-EACA
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.

  Baseline to Study Completion (Up To Day 42)

Secondary Outcomes (6)

• Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Zero to Infinity (AUC 0-∞) of Single Dose LY3127760

  Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours

• PK: Maximum Observed Concentration (Cmax) of Single Dose LY3127760

  Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours

• PK: Time of Maximum Observed Concentration (Tmax) of Single Dose LY3127760

  Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours

• PK: Area Under the Concentration Versus Time Curve During One Dosing Interval [AUC-tau (τ)] of Multiple Doses LY3127760

  Day 28: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, and 24 Hours

• PK: Cmax of Multiple Doses LY3127760

  Post last dose on Day 28: 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 72, and 168 Hours

Study Arms (5)

LY3127760 (Single)

EXPERIMENTAL

Single oral dose of up to 900 milligram (mg) LY3127760 administered in up to 3 of 3 study periods.

Drug: LY3127760; Drug: Placebo

Placebo (Single)

PLACEBO COMPARATOR

Single oral dose of placebo administered in up to 2 of 3 study periods. Placebo matches LY3127760 in appearance.

Drug: LY3127760; Drug: Placebo

LY3127760 (Multiple)

EXPERIMENTAL

Multiple ascending oral doses of up to 900 mg LY3127760 administered once or twice daily (QD or BID) for 28 days.

Drug: LY3127760; Drug: Placebo

Placebo (Multiple)

PLACEBO COMPARATOR

Multiple oral doses of placebo administered QD or BID for 28 days. Placebo matches LY3127760 in appearance.

Drug: LY3127760; Drug: Placebo

Celecoxib (Multiple)

ACTIVE COMPARATOR

Multiple oral doses of 400 mg celecoxib administered QD for 28 days.

Drug: LY3127760; Drug: Celecoxib; Drug: Placebo

Interventions

LY3127760 DRUG

Administered orally

Celecoxib (Multiple); LY3127760 (Multiple); LY3127760 (Single); Placebo (Multiple); Placebo (Single)

Celecoxib DRUG

Administered orally

Celecoxib (Multiple)

Placebo DRUG

Administered orally

Celecoxib (Multiple); LY3127760 (Multiple); LY3127760 (Single); Placebo (Multiple); Placebo (Single)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Evansville, Indiana, 47710, United States

Location

Related Publications (1)

• Jin Y, Smith C, Hu L, Coutant DE, Whitehurst K, Phipps K, McNearney TA, Yang X, Ackermann B, Pottanat T, Landschulz W. LY3127760, a Selective Prostaglandin E4 (EP4) Receptor Antagonist, and Celecoxib: A Comparison of Pharmacological Profiles. Clin Transl Sci. 2018 Jan;11(1):46-53. doi: 10.1111/cts.12497. Epub 2017 Aug 30.

  PMID: 28857461 DERIVED

MeSH Terms

Interventions

LY3127760; Celecoxib

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: October 23, 2013
• Study Start: October 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 7, 2019
• Results First Posted: June 7, 2019

Record last verified: 2019-03

Locations

US (1)