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Key Elements of a Phase 1 Clinical PK Study Protocol: Study Procedures

Part 3: Study Procedures

Screening (Day -28 through Day -1)

  • Obtain a signed informed consent form from the subject
  • Obtain a relevant medical history and document subject demographics
  • Assess vital signs and subject height/weight
  • Record prior medications
  • Conduct 12-Lead ECG (could be done in triplicate)
  • Obtain blood for serum pregnancy test
  • Collect blood for clinical laboratory analysis and analysis for HIV, hepatitis B, and hepatitis C analysis
  • Collect urine for urinalysis
  • Conduct a urine drug test
  • Conduct a physical examination
  • Confirmation of eligibility (inclusion/exclusion criteria)

CRU Admission (Day 0) – Baseline

  • Confirmation of eligibility (review inclusion/exclusion criteria)
  • Conduct physical examination (could be a reduced or abbreviated exam if needed)
  • Assess vital signs and subject weight
  • Collect blood for clinical laboratory analysis and urine for urinalysis
  • Obtain urine for urine pregnancy test
  • Conduct 12-Lead ECG
  • Conduct a urine drug test
  • Assess for prior medications

Procedures Prior to Dosing

  • Confirmation of eligibility (review inclusion/exclusion criteria)
  • Collect Pre-dose blood and urine for PK analysis
  • Assess vital signs and subject weight
  • Collect blood for clinical laboratory analysis and urine for urinalysis
  • Conduct 12-Lead ECG
  • Assess for prior medications
  • Randomization to treatment group (active or placebo)

Procedures for Dosing Subjects

  • Administer study drug with a specified amount of water (either 120 mL or 240 mL of water).  Subjects can consume more water if needed for compliance with the full dose of study drug.  Additional water use for study drug administration will be documented.

Post-Dose Procedures

  • Collect venous blood for PK analysis at [X, etc.] hours post-dose
  • Collect and pool urine at X-hour intervals after dosing (e.g., 0-X, X-X, X-X hour etc., intervals through X hours post-dose)
  • Collect vital signs at [X, etc.] hours post-dose
  • Collect venous blood for clinical laboratory analysis and urine for urinalysis at X hours post-dose
  • Collect 12-Lead ECG at X hours post-dose
  • Assess for AEs and concomitant medications

Discharge Procedures

  • Collect venous blood for PK analysis at [X, etc.] hours post-dose
  • Collect vital signs
  • Collect venous blood for clinical laboratory analysis and urine for urinalysis
  • Conduct 12-Lead ECG
  • Assess for AEs and concomitant medications
  • Conduct physical examination including assessment of weight
  • Assess for AEs and concomitant medications
  • Discharge from CRU

Speak with a clinical pharmacology/PK expert to help with your Phase 1 study from a scientific, operational, regulatory, clinical pharmacology, and pharmacokinetic perspective.

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