Phase 1
N=36
A Study of LY2216684 in Participants With Impaired Hepatic Function
Depressive Disorder, Major
Bottom Line
View on ClinicalTrials.gov: NCT01241435 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Pharmacokinetics: Area Under the Concentration Curve (AUC) — 601; 742; 961; 1020 hours times nanograms/milliliter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- LY2216684 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics: Area Under the Concentration Curve (AUC) |
601; 742; 961; 1020 | — |
| PRIMARY Pharmacokinetics: Maximum Concentration (Cmax) |
46.8; 39.6; 41.9; 34.7 | — |
| PRIMARY Pharmacokinetics: Time to Maximum Concentration (Tmax) |
3.00; 3.50; 3.50; 3.50 | — |
Summary
The purpose of this study is to evaluate the effect of liver function on how much of the study drug (LY2216684) gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.
The duration of participation in this study is approximately 12 days, not including the screening visit. This study requires 1 clinic confinement of 5 days/4 nights followed by 1 out-patient follow-up visit. A screening visit is required within 30 days prior to the start of the study. This research study will be an open-label study.
The study involves a single oral dose of 18 milligrams (mg) LY2216684 given as 2 tablets.
Eligibility Criteria
Inclusion Criteria
- Male participants: Agree to use a reliable method of birth control during the study and for 3 months 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, who have used a reliable method of birth control for 6 weeks prior to administration of study drug, and who agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug or are women not of child-bearing potential due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation) or menopause (at least 1 year without menses or 6 months without menses and follicle stimulating hormone [FSH] levels greater than or equal to 40 milli-internation units per milliliter [mIU/mL]).
- Have a body mass index (BMI) of 17.0 to 35.0 kilograms per meters squared (kg/m^2), inclusive, at screening.
- Have acceptable blood pressure and pulse rate (sitting) as determined by the investigator.
- Have venous access sufficient to allow blood sampling as per the protocol.
- Are reliable and willing to make themselves available for the duration of the study and to follow study procedures.
- Have given written informed consent approved by Lilly and the institutional review board (IRB) governing the site.
Control Participants (Participants with Normal Hepatic Function):
- Are overtly healthy, as determined by medical history and physical examination.
- Have clinical laboratory test results within normal reference ranges for the investigative site or results with acceptable deviations, which are judged to be not clinically significant by the investigator, at the time of screening.
Participants with Mild, Moderate, or Severe Hepatic Impairment:
- Participants with stable liver disease (alcoholic liver disease, post-hepatitis, biliary cirrhosis, cryptogenic) classified as Child-Pugh score A, B, or C (Pugh et al. 1973).
- Clinical laboratory test results with deviations that are judged by the investigator to be compatible with the hepatic impairment of the participant or of no additional clinical significance for this study.
Exclusion Criteria
All Participants:
- 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 used in this study 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 or related compounds.
- Are persons who have previously completed or withdrawn from this study or any other study investigating LY2216684 in the past 6 months from screening.
- Have an electrocardiogram (ECG) reading considered clinically significant by the investigator or a history of significant cardiac dysrhythmia or conduction defect that, in the opinion of the investigator, increases the risks associated with participating in the study.
- Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies.
- There is evidence or history of neurological disease such as transient ischemic attack, stroke, syncope episodes, encephalitis, or meningitis, except participants with liver disease-related encephalopathy may be allowed.
- Presence of acute infection with fever.
- Are women with a positive pregnancy test or women who are lactating.
- Have lost 500 milliliters (mL) or more of blood in the 3 months prior to study entry.
- Are participants who have an average weekly alcohol intake that exceeds 21 units per week, or are unwilling to adhere to restrictions during the study (1 unit = 12 ounces [oz] or 360 mL of beer, 5 oz or 150 mL of wine, or 1.5 oz or 45 mL of distilled spirits).
- Are participants who are unwilling to adhere to study caffeine restrictions.
- Are participants who are unwilling to abide by smoking restrictions whi
Data sourced from ClinicalTrials.gov (NCT01241435). 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.