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Flourish Research

Healthy Volunteers

Basic Criteria 

  • Be 40-65 years 
  • Have a BMI of 18.0-31 
  • In general good health 

 

Answers Must Be No 

  • Do you take any prescription or over-the-counter medicines (excluding acetaminophen) herbal remedies or supplements that you would not be able to discontinue during the 7 days of the study? DO NOT STOP NOW 
  • Do you regularly consume alcohol, defined as >21 alcohol units per week for men and >14 units for women 
  • Do you smoke anything (cigarettes or marijuana) (defined as >2 cigarettes a week) in the past year, or are an ex-smoker who gave up < 1 year ago. If you smoke less ≤2 cigarettes a week are you unwilling to abstain from smoking from 28 days prior to study admission through end of study? 
  • If female, are you of child-bearing potential (must be 1 year post-menopausal, bilateral oophorectomy, hysterectomy, bilateral salpingectomy or bilateral tubal ligation). 
  • Do you have any dietary restrictions?
  • Do you have a history of significant lung disease (pulmonary fibrosis, cystic fibrosis, COPD, emphysema, chronic pulmonary infections, recent upper or lower respiratory tract infections in the prior 8 weeks)  
  • Do you have a history of lung surgery or procedures? Do you have asthma (resolved childhood asthma OK)? 
  • Do you have any endocrine, thyroid or respiratory disease, diabetes, coronary heart disease, GI disease or history of psychotic mental illness?
  • Do you have a history of significant lung disease (pulmonary disease, cystic fibrosis, COPD, emphysema, chronic pulmonary infection) 
  • Have you had a recent upper or lower respiratory tract infection in the last 8 weeks? 
  • Do you have tongue, lip or nose piercings or broken teeth that would prevent you from inhaling study drug? 
  • Do you have any known abnormal liver functions? 
  • Do you have chronic kidney disease? 
  • Have you ever had pulmonary cancer? 
  • Have you had any cancers except for non-melanoma skin cancer in the past 5 years? 
  • Have you had an illness in the past four weeks with a fever? 
  • Are you allergic to nintedanib? 
  • Have you used erythromycin or  ketocanazole in the past 28 days? 
  • Have you had substance abuse issues in the past 2 years? 
  • Have you donated blood or blood products in the past 56 days? 
  • Have you received a live vaccine in the past 3 months? 
  • Do you have a history of parasitic infections? 
  • Have a history of surgery or medical intervention, planned surgery or medical intervention, that could interfere with the objectives of the study and your safety? 

 

Answers Must Be Yes 

  • If male, do you agree to use a condom during the study, even if you are vasectomized or your partner is not of childbearing potential? Must continue for 90 days after last dose of study drug. 
  • If male, with a WOCBP she must be surgically sterile (tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or use an acceptable method of contraceptives including oral contraceptives, vagina rings, contraceptive injection, IUD or etonogestrel implant. 
  • If male, do you agree to not donate sperm for at least 90 days after the last dose of study drug? 
  • Are you capable of performing spirometry? 
  • Are you willing to not consume poppy seeds within 24 hours of screening? 
  • Are you willing to abstain from alcohol use 48 hours prior to screening? 
  • Are you willing to adhere to the restrictions and requirements for the duration of the study? 
  • Additional criteria will apply

PLEASE NOTE: Please confirm your eligibility before your appointment by calling 210-714-0067.

If you do not see an available appointment, please call 210-714-0067.

Transportation may be available. Call 210-714-0067. Compensation up to $1,500 is available for time and travel.

 

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