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Table 1 Study screening, evaluation, and exit procedures

From: A phase I, placebo-controlled, randomized, double-blind, single ascending dose-ranging study to evaluate the safety and tolerability of a novel biophysical bronchodilator (S-1226) administered by nebulization in healthy volunteers

Procedure

Screening

Study day 1 (check-in)

Study day 1 (confinement)

Study day 2 (checkout)

Study exit (follow-up visit day 5 ± 1)

Demographic data

X

    

Medical and medication histories

X

    

Review of AEs and concomitant medications

 

X

  

X

Physical examination

X

X

 

X

X

Height and weight

X

    

Vital signs

X

X

Xa*

 

X

Tympanic temperature

X

X

  

X

Spirometryb

X

 

Xc*

  

Chest x-ray

X

    

ECG

X

 

Xd*

 

X

Biochemistry

X

X

Xe*

X

X

Hematology

X

X

Xf*

X

X

HIV and hepatitis

X

    

Urinalysis

X

X

 

X

X

Urine drug screen

X

X

   

Urine cotinine test

X

X

   

Alcohol breath test

X

X

   

Serum pregnancy test

X

X

   

Urine pregnancy test

    

X

Confinement

 

X

X

  

Drug administration

  

X

  

PK blood sample

  

Xe*

X

 

PK urine sample (for perflubron measurements)

  

Xg*

X

 

Pulse oximetry

X

X

Xa*

  

Adverse event monitoring

 

X

X

X

X

  1. AE adverse event, ECG electrocardiogram, PK pharmacokinetic
  2. * For study procedures scheduled at the same time point, the order of precedence is as follows:
  3. i. Blood draws (hematology and biochemistry)
  4. ii. ECG
  5. iii. Vital signs and pulse oximetry
  6. iv. Spirometry
  7. aBlood pressure, heart rate, respiratory rate, and pulse oximetry: predose and 20 minutes, 1 h, 2 h, 3 h, and 4 h postdose
  8. bFor screening, spirometry was forced expiratory volume in 1 second (FEV1) and forced vital capacity; for confinement, spirometry was FEV1 only
  9. cSpirometry within 1 h of drug administration (predose) and at 25 minutes, 1 h, 3 h, and 8 h (only if values before that are abnormal) after the end of study drug administration
  10. dECG predose and at 15 minutes, 1 h, 3 h, 4 h, and 8 h (only if values before that are abnormal) postdose
  11. eBiochemistry and PK blood samples were collected predose and at 3 minutes, 30 minutes, 1 h, 2 h, 4 h, 8 h, 12 h, and 24 h postdose
  12. fHematology was done predose and at 30 minutes, 2 h, 8 h, and 24 h postdose
  13. gUrine samples were collected over the following time intervals: predose and 0–4 h, 4–8 h, 8–12 h, and 12–24 h postdose
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Trials

ISSN: 1745-6215