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

NCT01236105 | Completed Phase 1 Results

• 2 other identifiers: 12814I2K-MC-ZZBQ
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-Time Curve (AUC) for LY2624803 and the Metabolite LSN2797276

  AUC from time 0, extrapolated to infinity, estimated for both LY2624803 and the metabolite LSN2797276.

  Predose and up to Day 4

• Maximum Concentration (Cmax) for LY2624803 and the Metabolite, LSN2797276,

  Cmax estimated for both LY2624803 and the metabolite LSN2797276.

  Predose and up to Day 4

Secondary Outcomes (1)

• Time to Maximum Plasma Concentration (Tmax) for LY2624803 and the Metabolite, LSN2797276

  Predose and up to day 4

Study Arms (3)

6 mg LY2624803 Alone Morning Dosing

EXPERIMENTAL

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

Drug: LY2624803

6 mg LY2624803 Morning Dosing + Activated Charcoal

EXPERIMENTAL

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; Other: Activated Charcoal

6 mg LY2624803 Alone Evening Dosing

EXPERIMENTAL

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

Drug: LY2624803

Interventions

LY2624803 DRUG

Administered orally (po), once.

6 mg LY2624803 Alone Evening Dosing; 6 mg LY2624803 Alone Morning Dosing; 6 mg LY2624803 Morning Dosing + Activated Charcoal

Activated Charcoal OTHER

Administered po

6 mg LY2624803 Morning Dosing + Activated Charcoal

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, LS2 9LH, United Kingdom

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Charcoal

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbon; Elements; Inorganic Chemicals

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2010
• First Posted: November 8, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 22, 2011
• Results First Posted: December 22, 2011

Record last verified: 2011-11

Locations

GB (1)