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Trial record 35 of 36 for:    AMINOCAPROIC ACID

A Study of LY3127760 in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01968070
Recruitment Status : Completed
First Posted : October 23, 2013
Results First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: LY3127760 Drug: Celecoxib Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Single- and Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of LY3127760 in Healthy Subjects
Study Start Date : October 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Arm Intervention/treatment
Experimental: LY3127760 (Single)
Single oral dose of up to 900 milligram (mg) LY3127760 administered in up to 3 of 3 study periods.
Drug: LY3127760
Administered orally

Drug: Placebo
Administered orally

Placebo Comparator: Placebo (Single)
Single oral dose of placebo administered in up to 2 of 3 study periods. Placebo matches LY3127760 in appearance.
Drug: LY3127760
Administered orally

Drug: Placebo
Administered orally

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

Drug: Placebo
Administered orally

Placebo Comparator: Placebo (Multiple)
Multiple oral doses of placebo administered QD or BID for 28 days. Placebo matches LY3127760 in appearance.
Drug: LY3127760
Administered orally

Drug: Placebo
Administered orally

Active Comparator: Celecoxib (Multiple)
Multiple oral doses of 400 mg celecoxib administered QD for 28 days.
Drug: LY3127760
Administered orally

Drug: Celecoxib
Administered orally

Drug: Placebo
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 Day 42) ]
    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.


Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Zero to Infinity (AUC 0-∞) of Single Dose LY3127760 [ Time Frame: Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours ]
  2. PK: Maximum Observed Concentration (Cmax) of Single Dose LY3127760 [ Time Frame: Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours ]
  3. PK: Time of Maximum Observed Concentration (Tmax) of Single Dose LY3127760 [ Time Frame: Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours ]
  4. PK: Area Under the Concentration Versus Time Curve During One Dosing Interval [AUC-tau (τ)] of Multiple Doses LY3127760 [ Time Frame: Day 28: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, and 24 Hours ]
    AUC-tau (τ) where τ is 24-hours for the 20 mg, 60 mg, and 200 mg cohorts, and 12-hours for the 300 mg cohort.

  5. PK: Cmax of Multiple Doses LY3127760 [ Time Frame: Post last dose on Day 28: 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 72, and 168 Hours ]
  6. PK: Tmax of Multiple Doses LY3127760 [ Time Frame: Post-last dose on Day 28: 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 72, and 168 Hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT01968070


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01968070     History of Changes
Other Study ID Numbers: 15181
I7A-MC-EACA ( Other Identifier: Eli Lilly and Company )
First Posted: October 23, 2013    Key Record Dates
Results First Posted: June 7, 2019
Last Update Posted: June 7, 2019
Last Verified: March 2019
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