A Study of LY2140023 in Healthy Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01609218
First received: May 29, 2012
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

The study will evaluate effect of activated charcoal on absorption of LY2140023. The study involves a single dose of 80 milligrams (mg) LY2140023 taken as 1 tablet by mouth two times during study (once with activated charcoal, once without activated charcoal). This study will last approximately 16 days not including screening. Screening is required within 30 days prior to study entry.


Condition Intervention Phase
Healthy Volunteer Study
Drug: LY2140023
Drug: Aqueous activated charcoal
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Study to Evaluate the Impact of Activated Charcoal on the Absorption of LY2140023 in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Pharmacokinetics: Maximum observed plasma concentration (Cmax) of LY2140023 [ Time Frame: Up to 24 hours after administration of study drug ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area under the concentration versus time curve from zero to last time point with a measurable concentration (AUC[0-inf]) of LY2140023 [ Time Frame: Up to 24 hours after administration of study drug ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Maximum observed plasma concentration (Cmax) of LY404039 (active moiety) [ Time Frame: Up to 24 hours after administration of study drug ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area under the concentration versus time curve from zero to last time point with a measurable concentration (AUC[0-inf]) of LY404039 (active moiety) [ Time Frame: Up to 24 hours after administration of study drug ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: May 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 80 mg LY2140023
Single oral dose of 80 mg LY2140023 administered alone
Drug: LY2140023
80 mg tablet LY2140023 monohydrate, administered orally
Experimental: 80 mg LY2140023 + 75 g aqueous activated charcoal
Single oral dose of 80 mg LY2140023 followed 1 hour later by single oral dose of 75 g aqueous activated charcoal
Drug: LY2140023
80 mg tablet LY2140023 monohydrate, administered orally
Drug: Aqueous activated charcoal
75 g aqueous activated charcoal, mixed with water and administered orally

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • are 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 for 3 months following the last dose of LY2140023, and agree not to donate sperm for 3 months following the last dose of LY2140023
  • female participants:

    • of childbearing potential, who test negative for pregnancy at screening and who agree to use a reliable method of birth control during the study and for 3 months following the last dose of LY2140023
    • of non-childbearing potential; postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy or confirmed tubal occlusion (not tubal ligation). Postmenopausal is defined as spontaneous amenorrhea for at least 12 months, and a plasma follicle-stimulating hormone (FSH) level >40 milli-international units per milliliter(mIU/mL), unless the participant is taking hormone replacement therapy • have given written informed consent approved by Lilly and the chosen ethical review board (ERB)

Exclusion Criteria:

  • are currently enrolled in, have completed or discontinued within the last 90 days from, a clinical trial involving an investigational product other than the investigational product 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 LY2140023 or LY404039, related compounds, activated charcoal, or any components of the formulation
  • are participants who have previously withdrawn from this study or any other study investigating LY2140023 after receiving at least 1 dose of LY2140023
  • show evidence or any history of significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, depression)
  • have increased risk of seizures based on a history of:
  • one or more seizures (except for a single simple febrile seizure [lacking focality and lasting less than 15 minutes, not associated with a central nervous system (CNS) infection or severe metabolic disturbance] as a child between ages 6 months to 5 years)
  • head trauma with loss of consciousness or a post-concussive syndrome within 1 year or lifetime history of head trauma with persistent neurological deficit (focal or diffuse)
  • CNS infection, uncontrolled migraine or transient ischemic attack (TIA) within 1 year; stroke with persistent neurological deficit (focal or diffuse), uncontrolled migraine is defined as migraine attacks that produce headache lasting up to 72 hours and are often accompanied by associated symptoms (nausea, photophobia, and phonophobia) that impair well-being and disrupt social functioning. TIA is defined as "mini-stroke" caused by temporary disturbance of blood supply to an area of the brain, which results in a sudden, brief decrease in brain function
  • CNS infection with persistent neurological deficit (focal or diffuse)
  • brain surgery
  • electroencephalogram (EEG) with paroxysmal (epileptiform) activity (isolated spikes waves, repetitive bursts of sharp waves, paroxysmal activity, frank seizures, spike-wave complexes, or sharp-slow wave complexes, or as locally defined)
  • brain structural lesion, including developmental abnormalities, as determined by examination or imaging studies (except hydrocephalus treated by shunt and without neurological deficit)
  • show evidence of active renal disease (for example, diabetic renal disease, polycystic kidney disease) or creatinine clearance less than 90 milliliters per minute (mL/min) as determined by the Cockroft Gault formula
  • show evidence or any history of known substance dependence or abuse at any time (according to Diagnostic and Statistical Manual of Mental Disorders [DSM-IV] diagnosis), or regularly use known drugs of abuse and/or show positive findings on urinary drug screening
  • have a clinically significant abnormality in the neurological examination
  • participants judged prior to randomization to be at suicidal risk by the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609218

Locations
United Kingdom
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.
Leeds, West Yorkshire, United Kingdom, LS2 9LH
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01609218     History of Changes
Other Study ID Numbers: 12858, H8Y-MC-HBCZ
Study First Received: May 29, 2012
Last Updated: October 4, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Charcoal
Antidotes
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014