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Phase 1 Completed N=14 Treatment

A Study to Evaluate the Effect of Clarithromycin on LY2216684

Depressive Disorder, Major
Source: ClinicalTrials.gov NCT01460407 ↗
Enrolled (actual)
14
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 — 582; 746 nanogram*hours per milliliter (ng*h/mL)

Summary

The study will evaluate the effect of Clarithromycin on the pharmacokinetics (PK) of LY2216684 in healthy participants. Side effects will be documented. There will be 2 study periods (5 and 9 days) and follow up will occur at least 7 days after the last dose. Screening is required within 45 days prior to the start of the study.

Outcome Measures

OutcomeResultp-value
PRIMARY
Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of LY2216684
582; 746
PRIMARY
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2216684
52.58; 63.55
PRIMARY
Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of LY2216684
2.00; 2.00 0.7656

Eligibility Criteria

Inclusion Criteria

  • Are overtly healthy as determined by medical history and physical examination
  • Male participants:

o Agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug

  • Female participants:

o Are women of child-bearing potential who test negative for pregnancy at the time of enrollment, have used a reliable method of birth control (not including hormonal contraceptives) for 4 weeks 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, bilateral oophorectomy, or tubal ligation/occlusion) or menopause [at least 1 year without menses or 6 months without menses and a follicle stimulating hormone (FSH) >40 milli-international units per milliliter (mIU/mL)]

  • Have a body weight >50 kilograms (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 (PR) (sitting position) as determined by the investigator
  • Are predicted to have both cytochrome P450 (CYP)2D6 and CYP2C19 extensive metabolizer (EM) phenotypes as determined by genotyping assessment

Exclusion Criteria

  • Are currently enrolled in, have completed or discontinued within the last 30 days from a clinical trial involving an investigational product 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/intolerance to LY2216684 or clarithromycin, 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 with a positive pregnancy test or 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)
  • Use of known inhibitors and/
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01460407). 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.

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