A Study of LY3031207 in Healthy Subjects

NCT01449630 | Completed Phase 1 Results

• 2 other identifiers: 14283I5W-EW-LBCA
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I study of LY3031207 in healthy subjects. The purposes of this study are to look at safety, how well the study drug is tolerated, and how much of the study drug gets into the blood stream and how long it takes the body to get rid of it when given to humans. Information about any side effects that may occur will also be collected. Subjects will participate in the study for approximately 3 months. This study is for research purposes only and is not intended to treat any medical condition.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of Participants With 1 or More Drug Related Adverse Events (AE) or Any Serious AE

  AEs that were considered possibly related to study drug, in the opinion of the investigator, were reported. A summary of serious and all other non-serious AEs, regardless of possible drug relatedness, is located in the Reported Adverse Event module.

  Baseline, up to 4 months

Secondary Outcomes (6)

• Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of LY3031207

  Predose, 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, 96, 144 hours post dose

• Pharmacokinetics: Maximum Concentration (Cmax) of LY3031207

  Predose, 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, 96, 144 hours post dose

• Pharmacodynamics: Percent Change From Baseline of Ex Vivo Whole Blood Prostaglandin E (PGE) Synthesis After Lipopolysaccharide (LPS) Stimulation

  Predose, 0.5, 1, 2, 8, 24 and 144 hours post dose.

• Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostaglandin E(2) Metabolite (PGEM)

  0 to 2, 2 to 4, 4 to 6, 6 to 12 and 12 to 24 hours post dose

• Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostacyclin Metabolite (PGIM)

  0 to 2, 2 to 4, 4 to 6, and 6 to 12 hours post dose

Study Arms (3)

LY3031207

EXPERIMENTAL

Participants received escalating doses of 5 mg (milligrams), 25 mg, 75 mg, 225 mg, 450 mg and 900 mg of LY3031207 capsule orally.

Drug: LY3031207

Placebo

PLACEBO COMPARATOR

Single dose of placebo administered orally in up to two occasions separated by at least a 3 week wash-out period between each dose.

Drug: Placebo

Celecoxib

ACTIVE COMPARATOR

Single 400mg dose of celecoxib administered orally on one occasion.

Drug: Celecoxib

Interventions

LY3031207 DRUG

Administered orally

LY3031207

Placebo DRUG

Administered orally

Placebo

Celecoxib DRUG

Administered orally

Celecoxib

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male subjects agree to use a reliable method of birth control during the study and for 3 months following the last dose of the investigational product
• Women not of child-bearing potential due to surgical sterilization (at least 6 weeks after surgical bilateral oophorectomy with or without hysterectomy or at least 6 weeks after tubal ligation) confirmed by medical history or menopause
• Menopausal women include women with either spontaneous amenorrhea for at least 12 months, not induced by a medical condition such as anorexia nervosa and not taking medications during the amenorrhea that induced the amenorrhea (for example \[e.g.\], oral contraceptives, hormones, gonadotropin-releasing hormone, antiestrogens, selective estrogen receptor modulators, or chemotherapy) or spontaneous amenorrhea for 6 to 12 months and a follicle-stimulating hormone level greater than 40 milli-International Unit (mIU/mL)
• Overtly healthy based on the history and physical examinations as determined by the investigator
• Between body mass index (BMI) of 18.5 and 32.0 kilogram per meter squared (kg/m\^2), inclusive
• Normotensive defined as supine systolic blood pressure (BP) \<140 of millimeter mercury (mmHg), and diastolic BP \<90 mmHg, without the use of any antihypertensives, or results that are judged to be not clinically significant by the Investigator. Blood pressure may be retested up to 2 additional times, under well rested conditions
• Clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
• Ex vivo whole blood prostaglandin E(PGE) synthesis after lipopolysaccharide (LPS) stimulation of no less than 5 nanograms/milliliter (ng/mL).
• Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
• Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site

You may not qualify if:

• Are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product or unapproved use of a drug with a short half-life, or within 5 half-life of an investigational product with a half-life longer than 5 days, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
• Have known allergies to LY3031207 or any components of the formulation, celecoxib or sulfonamides. Subjects with known aspirin allergy or allergic reaction to non-steroidal anti-inflammatory drugs (NSAIDs) should also be excluded
• Are persons who have previously completed or withdrawn from this study or any other study investigating LY3031207 and who have previously received the investigational product
• Have an abnormality in the 12-lead Electrocardiogram (ECG), including QTc interval with Bazett's correction \>450 millisecond (msec) for men and \>470 msec for women or an abnormality that, in the opinion of the investigator, increases the risks associated with participating in the study. Electrocardiogram may be repeated after 5 minutes resting quietly, if the subject's heart rate is \>75 beats per minute
• History of, within the last 2 years, or presence of active cardiovascular disease, including acute myocardial infarction, unstable angina, congestive heart failure, stroke, or transient ischemic attack
• Presence of clinically significant active bleeding or history of bleeding diathesis at the time of screening
• Presence of active peptic ulcer disease, Gastrointestinal (GI) bleeding, chronic gastritis, inflammatory bowel disease, chronic diarrhea, or positive H. pylori serology
• Evidence of hepatitis C and/or positive hepatitis C antibody
• Evidence of hepatitis B and/or positive hepatitis B surface antigen
• Evidence of other chronic liver disease, including chronic alcoholic disease; non-alcoholic steatohepatitis; recent (within 3 months of screening) history of acute viral hepatitis; or subjects with known Gilbert Syndrome
• History of active neuropsychiatric disease
• Evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies
• Regularly use of known drugs of abuse and/or show positive findings on urinary drug screening
• Are women with a positive pregnancy test or women who are lactating
• Intended use of over-the-counter medications or prescription medication within 14 days prior to dosing, this includes but is not limited to antihypertensives, diuretics, antiplatelet or anticoagulant drugs, and antidepressants

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

MeSH Terms

Interventions

LY3031207; 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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2011
• First Posted: October 10, 2011
• Study Start: October 24, 2011
• Primary Completion: April 2, 2012
• Study Completion: April 2, 2012
• Last Updated: July 5, 2019
• Results First Posted: July 5, 2019

Record last verified: 2019-06

Locations

US (1)