A Multiple Dose Study of LY3023703 in Healthy Participants

• ClinicalTrials.gov Identifier: NCT01849055
• Recruitment Status: Completed
• First Posted: May 8, 2013
• Results First Posted: December 14, 2018
• Last Update Posted: December 14, 2018
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Study Description

Brief Summary:

This is a study of LY3023703 in healthy participants. The purposes of this study are to look at safety, how well the study drug is tolerated, how much of the study drug gets into the blood stream and how long it takes the body to remove the study drug. The effects of LY3023703 on blood pressure after 28 days of dosing will be studied. Information about any side effects that occur will be collected. The study is expected to last 21 weeks.

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers	Drug: Placebo; Drug: LY3023703; Drug: Celecoxib	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3023703 in Healthy Subjects
• Study Start Date: May 2013
• Actual Primary Completion Date: December 2013
• Actual Study Completion Date: December 2013

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Placebo matching LY3023703 administered orally, once daily (QD), for 28 days	Drug: Placebo; Administered orally
Experimental: LY3023703; Escalating doses (2.5 milligram [mg] up to 30 mg) of LY3023703 administered orally, QD, for 28 days	Drug: LY3023703; Administered orally
Active Comparator: Celecoxib; 400 mg celecoxib administered orally, QD, for 28 days. (Positive control.)	Drug: Celecoxib; Administered orally

Outcome Measures

Primary Outcome Measures :

1. 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 (up to 74 Days) ]
   A summary of serious and all other non-serious adverse events (AE), regardless of possible study drug relatedness, is located in the Reported Adverse Events module.

Secondary Outcome Measures :

1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve [AUC(0-24)] of LY3023703 [ Time Frame: Post-First Dose on Days 1-28 (Time Frame: Day 1: -0.5, 1, 2, 4, 8, 12, 24 hours; Days 5, 12, 20: -0.5 hours; Day 28: -0.5, 1, 2, 4, 8, 12, 24 hours.) ]
2. Pharmacokinetics: Maximum Concentration (Cmax) of LY3023703 [ Time Frame: Post first dose on Day 1 through Day 28 (Time Frame: Day 1: -0.5, 1, 2, 4, 8, 12, 24 hours; Days 5, 12, 20: -0.5 hours; Day 28: -0.5, 1, 2, 4, 8, 12, 24 hours.) ]
3. Pharmacokinetics: Time of Maximum Concentration (Tmax) of LY3023703 [ Time Frame: Post first dose on Day 1 through Day 28 (Time Frame: Day 1: -0.5, 1, 2, 4, 8, 12, 24 hours; Days 5, 12, 20: -0.5 hours; Day 28: -0.5, 1, 2, 4, 8, 12, 24 hours.) ]
4. Change From Baseline to Day 27 in Blood Pressure (BP) [ Time Frame: Baseline, Day 27 ]
   The Day 27 change from Day -1 was analyzed by using analysis of covariance (ANCOVA) with treatment as a fixed effect and baseline Day -1 as a covariate. The treatment mean, difference to placebo, and difference to celecoxib were output with corresponding 90% confidence intervals.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Overtly healthy individuals based on the history and physical examinations as determined by the investigator
• 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 the use of any antihypertensives) or results that are judged to be not clinically significant by the investigator

Exclusion Criteria:

• Have presence of clinically significant active bleeding or history of bleeding diathesis at the time of screening
• Have presence of active peptic ulcer disease, gastro-intestinal (GI) bleeding, chronic gastritis, inflammatory bowel disease, or chronic diarrhea
• Have evidence of other chronic liver disease
• Have any use of nonsteroidal anti-inflammatory drugs (NSAIDs), celecoxib, aspirin, or acetaminophen (at doses greater than 1 gram per day [g/day] within 14 days of admission
• Have greater than 1 plus pretibial pitting edema or 2 plus ankle or pedal edema

Contacts and Locations

Locations

United States, Indiana

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, United States, 47710

Sponsors and Collaborators

Eli Lilly and Company

Investigators

• Study Director: 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

More Information

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT01849055
• Other Study ID Numbers: 14708; I6H-MC-MCBB ( Other Identifier: Eli Lilly and Company )
• First Posted: May 8, 2013
• Results First Posted: December 14, 2018
• Last Update Posted: December 14, 2018
• Last Verified: July 2018

Additional relevant MeSH terms:

Celecoxib; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase 2 Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action