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

Insomnia Clinical Trial

Official title:

Evaluation of the Impact of Activated Charcoal and Time of Dose on the Absorption of LY2624803 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236105
• Other study ID #: 12814
• Secondary ID: I2K-MC-ZZBQ
• Status: Completed
• Phase: Phase 1
• First received: November 4, 2010
• Last updated: November 17, 2011
• Start date: October 2010
• Est. completion date: December 2010

Study information

• Verified date: November 2011
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Insomnia

Intervention

Drug:
• LY2624803
Administered orally (po), once.

Other:
• Activated Charcoal
Administered po

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Maximum Concentration (Cmax) for LY2624803 and the Metabolite, LSN2797276,	Cmax estimated for both LY2624803 and the metabolite LSN2797276.	Predose and up to Day 4	No
Secondary	Time to Maximum Plasma Concentration (Tmax) for LY2624803 and the Metabolite, LSN2797276	Tmax, estimated for both LY2624803 and the metabolite LSN2797276.	Predose and up to day 4	No