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A Multiple-dose Study of LY3031207 in Healthy Participants

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ClinicalTrials.gov Identifier: NCT01632566
Recruitment Status : Terminated (Elevation of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in some participants.)
First Posted : July 3, 2012
Results First Posted : June 27, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
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 get rid of it when given to healthy Japanese and non-Japanese participants as multiple doses. In addition, effects of 28-day oral dosing of LY3031207 on the amount of a cholesterol-lowering drug (simvastatin) that gets into the blood stream and how long the body takes to get rid of it will be determined. The effects of LY3031207 after single and 28-day dosing on blood pressure will also be studied. Information about any side effects that may occur will be collected.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Placebo Drug: LY3031207 Drug: Celecoxib Drug: Simvastatin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 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 LY3031207 in Healthy Subjects
Study Start Date : June 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Arm Intervention/treatment
Placebo Comparator: Placebo
Daily oral administration of placebo for 28 days. Dose will match corresponding LY3031207 dosage.
Drug: Placebo
Capsules administered orally

Experimental: LY3031207
Daily oral administration of 25 milligrams (mg) LY3031207 up to 450 mg LY3031207 for 28 days.
Drug: LY3031207
Administered orally

Active Comparator: Celecoxib
Daily oral administration of 400 mg celecoxib for 28 days. Positive control for LY3031207.
Drug: Celecoxib
Administered orally

LY3031207 + Simvastatin
Daily oral administration of 75 mg LY3031207 or 225 mg LY3031207 for 28 days. Single, oral 10 mg simvastatin open-label dose administered before and after 28-day dosing of LY3031207.
Drug: Simvastatin
Administered orally




Primary Outcome Measures :
  1. Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs [ Time Frame: Baseline to study completion (treatment completion and follow-up, up to 35 weeks) ]

    A treatment emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs postdose or that is present predose and becomes more severe postdose. AEs presented are of all causalities and all severities.

    A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.



Secondary Outcome Measures :
  1. Pharmacokinetics: Maximum Concentration (Cmax) of LY3031207 [ Time Frame: Predose up to 48 hours post last dose at Day 28 ]
    Maximum concentration (Cmax) of LY3031207 post-repeated once daily doses at Day 28. Day 28 results were not calculated for participants who received 225 mg LY3031207 because the study was terminated prior to participants reaching 28 days of dosing for this treatment arm.

  2. Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3031207 [ Time Frame: Predose up to 48 hours post last dose at Day 28 ]
    Area under the concentration versus time curve in a dosing interval (AUC[0-tau]) of LY3031207 post-repeated once daily doses at Day 28. Day 28 results were not calculated for participants who received 225 mg LY3031207 because the study was terminated prior to participants reaching 28 days of dosing for this treatment arm.

  3. Pharmacokinetics: Time of Maximum Concentration (Tmax) of LY3031207 [ Time Frame: Predose up to 48 hours post last dose at Day 28 ]
    Time of maximum concentration (Tmax) of LY3031207 post-repeated once daily doses at Day 28. Day 28 results were not calculated for participants who received 225 mg LY3031207 because the study was terminated prior to participants reaching 28 days of dosing for this treatment arm.

  4. Pharmacokinetics: Maximum Concentration (Cmax) of Simvastatin [ Time Frame: Predose up to 48 hours post dose at Day -3 and Day 28 ]
  5. Pharmacokinetics: Area Under the Concentration Curve (AUC) of Simvastatin [ Time Frame: Predose up to 48 hours post dose at Day -3 and Day 28 ]
    Area under the concentration versus time curve over the range of all measureable concentrations (AUC[0-tlast]) of simvastatin.

  6. Pharmacokinetics: Time of Maximum Concentration (Tmax) of Simvastatin [ Time Frame: Predose up to 48 hours post dose at Day -3 and Day 28 ]
  7. Change From Baseline to Day 28 in Urinary Prostacyclin I (PGI) Metabolite Excretion [ Time Frame: Baseline, Predose up to 12 hours prior to last dose at Day 28 ]
  8. Change From Baseline to Day 28 in Urinary Prostaglandin E (PGE) Metabolite Excretion [ Time Frame: Baseline, Predose up to time of last dose at Day 28 ]
  9. Change From Baseline to Day 28 in Urinary Thromboxane A (TXA) Metabolite Excretion [ Time Frame: Baseline, Predose up to 12 hours prior to last dose at Day 28 ]


Information from the National Library of Medicine

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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, including first generation Japanese
  • Body mass index between 17.0 and 32.0 kilograms per square meter (kg/m^2), inclusive

Exclusion Criteria:

  • Have known allergies to LY3031207 or any components of the formulation, simvastatin or related compounds (other 3-Hydroxy-3-Methyl-Glutaryl-CoA [HMG CoA] reductase inhibitors), celecoxib, or sulfonamides. Participants with known aspirin allergy or allergic reaction to nonsteroidal anti-inflammatory drugs (NSAIDs) should also be excluded

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): NCT01632566


Locations
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United States, Hawaii
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.
Honolulu, Hawaii, United States
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: NCT01632566     History of Changes
Other Study ID Numbers: 14284
I5W-EW-LBCB ( Other Identifier: Eli Lilly and Company )
First Posted: July 3, 2012    Key Record Dates
Results First Posted: June 27, 2019
Last Update Posted: June 27, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Simvastatin
Celecoxib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
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