Phase 1 Completed N=22 Randomized Treatment

A Study to Evaluate the Effect of Activated Charcoal on the Absorption of LY2216684 in Healthy Subjects

Depressive Disorder, Major

Source: ClinicalTrials.gov NCT01389752 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2018

Primary outcomePrimary: Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of LY2216684 — 509; 786 nanogram*hour/milliliter (ng*h/mL)

Summary

The study involves a single oral dose of 18 mg (2 x 9mg tablets) LY2216684 taken on 2 occasions, once with activated charcoal and once without activated charcoal. The study will evaluate the effect of charcoal on the absorption of LY2216684. Side effects will be documented. There will be 2 study periods each lasting up to 5 days. There will be at least 7 days between the two doses and a follow up will occur at least 7 days after the last dose. Screening is required within 30 days prior to the start of the study.

Outcome Measures

Outcome	Result	p-value
PRIMARY Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of LY2216684	509; 786	—
PRIMARY Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2216684	54.06; 59.84	—
PRIMARY Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of LY2216684	2.00; 2.03	0.0010 sig

Eligibility Criteria

Inclusion Criteria

Are overtly healthy, as determined by medical history and physical examination
Male subjects: Agree to use a reliable method of birth control during the study and for 1 month following the last dose of the study drug
Female subjects: Are women of child-bearing potential who test negative for pregnancy at the time of enrollment, have used a reliable method of birth control prior to administration of study drug, and agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug; or women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause (at least 1 year without menses or 6 months without menses and a follicle stimulating hormone [FSH] >40 mIU/mL [milli-international-units/milliliter])
Have a body weight >50 kg
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 for 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 institutional review board (IRB) governing the site
Have normal blood pressure (BP) and pulse rate (sitting position)

Exclusion Criteria

Are currently enrolled in, have completed or discontinued within the last 30 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 LY2216684, related compounds, or any components of the formulation
Are persons who have previously received the investigational product in this study, have completed or withdrawn from this study or any other study investigating LY2216684 within 6 months prior to Screening
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 a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, 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
Have a history or show evidence of significant active neuropsychiatric disease or have a history of suicide attempt or ideation
Have a documented or suspected history of glaucoma
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Show evidence of human immunodeficiency virus (HIV) infection 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 who are lactating
Intend to use over-the-counter or prescription medication within 14 days prior to dosing unless deemed acceptable by the investigator and Sponsor's medical monitor. Exceptions include influenza vaccinations, the use of topical medication (provided there is no evidence of chronic dosing with the risk of systemic exposure), occasional use of acetaminophen/paracetamol/ibuprofen, hormone replacement therapy including thyroid replacement (stable dose for at least 1 month), and stable doses (at least 1 month) of oral contraceptive therapy
Have donated blood of more than 500 mL (milliliter) within the last month
Have an average weekly alcohol intake that exceeds 21 units per week (males) or 14 units per week (females), or are unwilling to stop alcohol consumption from 48

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Data sourced from ClinicalTrials.gov (NCT01389752). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.