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

NCT ID: NCT01236105

Last Updated: 2011-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2010-12-31

Brief Summary

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.

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

6 mg LY2624803 Alone Morning Dosing

Participants received 6 milligrams (mg) LY2624803 alone orally (po) at approximately 0800 hours following an overnight fast.

Group Type: EXPERIMENTAL

LY2624803

Intervention Type: DRUG

Administered orally (po), once.

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.

Group Type: EXPERIMENTAL

LY2624803

Intervention Type: DRUG

Administered orally (po), once.

Activated Charcoal

Intervention Type: OTHER

Administered po

6 mg LY2624803 Alone Evening Dosing

Participants received 6 mg LY2624803 alone po at approximately 2200 hours following a 4-hour fast.

Group Type: EXPERIMENTAL

LY2624803

Intervention Type: DRUG

Administered orally (po), once.

Interventions

LY2624803

Administered orally (po), once.

Intervention Type: DRUG

Activated Charcoal

Administered po

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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

Countries

United Kingdom

Other Identifiers

I2K-MC-ZZBQ

Identifier Type: OTHER

Identifier Source: secondary_id

12814

Identifier Type: -

Identifier Source: org_study_id