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Phase 1 Completed N=18 Treatment

A Study of LY2216684 and Warfarin in Healthy Subjects

Source: ClinicalTrials.gov NCT01263119 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of S-Warfarin — 22200; 20800 nanogram*hour per milliliter (ng*hr/mL)

Summary

The purpose of this study is to determine how warfarin might affect LY2216684 and how giving LY2216684 might affect warfarin in the body. Information about any side effects that may occur will also be collected.

Outcome Measures

OutcomeResultp-value
PRIMARY
Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of S-Warfarin
22200; 20800
PRIMARY
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of S-Warfarin
633.00; 566.57
PRIMARY
Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of S-Warfarin
3.00; 3.00 0.9551
SECONDARY
Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of R-Warfarin
43600; 38000
SECONDARY
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of R-Warfarin
669.25; 592.38
SECONDARY
Pharmacokinetics: Time to Maximum Concentration (Tmax) of R-Warfarin
3.02; 4.00 0.6094
SECONDARY
Pharmacodynamics: Area Under the Curve of the International Normalized Ratio (AUCINR) of Warfarin
155; 149
SECONDARY
Pharmacodynamics: Maximum Observed International Normalized Ratio (INRmax)
1.19; 1.14

Eligibility Criteria

Inclusion Criteria

  • Are overtly healthy, as determined by medical history and physical examination
  • Male participants - Agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug
  • Female participants - Are women of child-bearing potential who test negative for pregnancy at the time of enrollment, have used a reliable method of birth control for 6 weeks prior to administration of study drug, and agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug; or women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause (at least 1 year without menses or 6 months without menses and a follicle stimulating hormone [FSH] >40 mass International Units per milliliter [mIU/mL])
  • Have body weight >50 kilogram (kg)
  • Have 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
  • Have venous access sufficient to allow blood sampling as per the protocol
  • Have normal blood pressure and pulse rate (sitting position) as determined by the investigator
  • 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
  • Are cytochrome P450 2C9 (CYP2C9) extensive metabolizers, as determined by genotyping assessment

Exclusion Criteria

  • Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device other than the study drug, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Have known allergies to LY2216684, warfarin, or related compounds
  • Are persons who have previously completed or withdrawn from this study or any other study investigating LY2216684 within 6 months prior to screening
  • Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
  • Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
  • Have a history or show evidence of significant active neuropsychiatric disease, or have a history of suicide attempt or ideation
  • Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
  • Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies
  • Show evidence of hepatitis C and/or positive hepatitis C antibody
  • Show evidence of hepatitis B and/or positive hepatitis B surface antigen
  • Are women with a positive pregnancy test or women who are lactating
  • Intend to use over-the-counter or prescription medication (including hormonal contraceptives) within 14 days prior to dosing unless deemed acceptable by the investigator and sponsor's medical monitor
  • Use of any drugs or substances that are known to be substrates, inducers, or inhibitors of cytochrome P450 2C19 (CYP2C19) or CYP2C9 within 30 days prior to dosing
  • Have donated blood of more than 500 mL within the last month
  • Have an average weekly alcohol intake that exceeds 14 units per week, or are unwilling to stop alcohol consumption 48 hours prior to dosing in each period and while resident at the CRU (1 unit = 12 ounces [oz] or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
  • Consume 5 or more
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01263119). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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