Effect of Activated Charcoal and Time of Dose on the Pharmacokinetics of LY2624803 in Healthy Subject

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01236105
First received: November 4, 2010
Last updated: November 17, 2011
Last verified: November 2011
  Purpose

The purpose of this study is to determine the effect of activated charcoal and dosing time on the absorption of LY2624803 in healthy subjects. In this crossover study, there are three treatments with a washout period of at least 7 days in between treatments. Each subject will participate in all three treatments with random assignment to the treatment sequence.


Condition Intervention Phase
Insomnia
Drug: LY2624803
Other: Activated Charcoal
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Evaluation of the Impact of Activated Charcoal and Time of Dose on the Absorption of LY2624803 in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Area Under the Concentration-Time Curve (AUC) for LY2624803 and the Metabolite LSN2797276 [ Time Frame: Predose and up to Day 4 ] [ Designated as safety issue: No ]
    AUC from time 0, extrapolated to infinity, estimated for both LY2624803 and the metabolite LSN2797276.

  • Maximum Concentration (Cmax) for LY2624803 and the Metabolite, LSN2797276, [ Time Frame: Predose and up to Day 4 ] [ Designated as safety issue: No ]
    Cmax estimated for both LY2624803 and the metabolite LSN2797276.


Secondary Outcome Measures:
  • Time to Maximum Plasma Concentration (Tmax) for LY2624803 and the Metabolite, LSN2797276 [ Time Frame: Predose and up to day 4 ] [ Designated as safety issue: No ]
    Tmax, estimated for both LY2624803 and the metabolite LSN2797276.


Enrollment: 21
Study Start Date: October 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 6 mg LY2624803 Alone Morning Dosing
Participants received 6 milligrams (mg) LY2624803 alone orally (po) at approximately 0800 hours following an overnight fast.
Drug: LY2624803
Administered orally (po), once.
Experimental: 6 mg LY2624803 Morning Dosing + Activated Charcoal
Participants received 6 mg LY2624803 po at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.
Drug: LY2624803
Administered orally (po), once.
Other: Activated Charcoal
Administered po
Experimental: 6 mg LY2624803 Alone Evening Dosing
Participants received 6 mg LY2624803 alone po at approximately 2200 hours following a 4-hour fast.
Drug: LY2624803
Administered orally (po), once.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Are overtly healthy males or females, as determined by medical history and physical examination.
  • Male subjects with female partners of child-bearing potential and female subjects of child-bearing potential, agree to use 2 reliable methods of contraception from the time of the first dose until 3 months after the last dose of study drug or are women not of child-bearing potential due to postmenopausal or permanently sterilized [for example, tubal occlusion, hysterectomy, bilateral salpingectomy]).
  • Have a body mass index (BMI) between 18.5 and 32 kilograms per square meter (kg/m2), inclusive, and a body weight of 50 kg or above at screening.
  • 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.
  • 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 governing the site.

Exclusion Criteria:

  • Are currently enrolled in, or discontinued within the last 90 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 LY2624803 or related compounds.
  • Are persons who have previously completed or withdrawn from this study or any other study investigating LY2624803.
  • 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 an abnormal blood pressure as determined by the investigator.
  • Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal (except appendectomy), endocrine, hematological, dermatological, venereal, 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.
  • Show evidence or history of postural hypotension, loss of consciousness, explained or unexplained syncope or seizure episodes or a family history of seizures. A history of a single febrile convulsion is acceptable.
  • Show evidence of significant active neuropsychiatric disease.
  • 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 medications, with the exception of vitamins and paracetamol, which cannot be safely discontinued within 7 days prior to admission.
  • Have donated blood of more than 500 milliliters (mL) within the last 3 months prior to screening.
  • Have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per week (females), and are subjects unwilling to stop alcohol consumption from 48 hours prior to admission until discharge from the unit for each treatment period, and to limit alcohol intake to a maximum of 2 units/day between treatment periods.
  • Have a history of breast cancer.
  • Are subjects with excessive xanthine consumption.
  • Exhibit any other condition, which, in the opinion of the investigator would preclude participation in the study.
  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: NCT01236105

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: NCT01236105     History of Changes
Other Study ID Numbers: 12814, I2K-MC-ZZBQ
Study First Received: November 4, 2010
Results First Received: November 17, 2011
Last Updated: November 17, 2011
Health Authority: United States: Food and Drug Administration
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 July 22, 2014