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A Multiple Dose Study of LY3023703 in Healthy Participants

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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:
Information provided by (Responsible Party):
Eli Lilly and Company

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

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

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




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849055


Locations
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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
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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

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

Additional relevant MeSH terms:
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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