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

by Scientific Writing Team

Part 2: Study Objectives and Inclusion/Exclusion Criteria

Phase 1 Study Objectives

1) To evaluate the pharmacokinetics and safety of DRUG X in healthy volunteer
2) To identify the maximum tolerated single dose (MTD)

Inclusion Criteria

  • Signed and dated Institutional Review Board-approved informed consent is obtained prior to the conduct of any study activities
  • Subject is between 18 and 45 years of age, inclusive
  • Female subjects are non-pregnant, non-lactating, and practicing an acceptable method of birth control, or be surgically sterile or post-menopausal
  • Subject has a body mass index between 18 and 32 kg/m2, inclusive
  • Negative urine drug screen
  • Negative Screening assessment for human immunodeficiency virus or viral hepatitis (Hep B or Hep C) or has a history of HIV infection/acquired immune deficiency syndrome
  • Subject agrees to ABSTAIN from using tobacco or nicotine-containing products, consuming alcohol, grapefruit, or grapefruit juice, or taking any prescription drugs, dietary supplements or non-prescription drugs (unless approved by the Investigator and Medical Monitor) from CRU admission through follow-up
  • Subject is able to communicate effectively with study personnel and is willing to comply with protocol requirements

Exclusion Criteria

  • Subject has a current acute or chronic disease
  • Subject has any clinical significant laboratory value (per Investigator judgment) outside the normal range at Screening
  • Subject has clinically significant abnormal findings from physical examination conducted at Screening and CRU admission
  • Subject has a clinically important history of a medical disorder that would compromise subject safety or data quality (per Investigator’s judgment)
  • Subject has a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically important reaction to any drug
  • Subject has donated blood or plasma within 30 days prior to CRU admission
  • Subject has received another investigational drug or has participated in an investigational drug or device study within the 30 days prior to CRU admission
  • Subject has a history of drug abuse within 6 months prior to Screening or exhibits evidence of drug abuse at Screening or CRU admission
  • Subject currently uses tobacco and nicotine-containing products or has used such products within 60 days prior to the CRU admission
  • Subject has consumed any dietary supplements or non-prescription drugs within 3 days prior to CRU admission or has consumed any prescription drugs with 14 days prior to CRU admission
  • Subject has consumed alcohol within 3 days prior to CRU admission
  • Subject has consumed grapefruit or grapefruit juice within the 14 days prior to CRU admission

Questions Nuventra can help answer for a Phase 1 Clinical Pharmacology Study:

  • What type of inclusion/exclusion criteria are needed for specific clinical pharmacology studies (e.g., for a single-ascending dose (SAD), First-Time-In-Humans (FTIH), multiple ascending dose (MAD), drug-drug interaction (DDI), renal impairment, hepatic impairment, ADME, thorough QT (TQT), food-effect, bioequivalence (BE), or bioavailability (BA) clinical pharmacology Phase I study)?
  • How long should subjects in a Phase 1 study washout of medications (prescription drugs and non-prescriptions/over-the-counter [OTC] drugs) before dosing with an investigational drug?
  • Should subjects who smoke be excluded from a Phase 1 study?
  • Should Phase 1 clinical studies have a placebo control (double-blind, placebo-controlled Phase 1 study)?
  • Do males need to use birth control in a Phase 1 study?
  • What body mass index (BMI) to use in a Phase 1 study?
  • Should poly-pharmacy patients with a specific disease be enrolled in a Phase 1 study?
  • Can subjects take vitamins during a clinical PK Phase 1 study?
  • How does inclusion/exclusion criteria in a Phase 1 study impact a Phase 2 proof of concept study or a pivotal Phase 3 efficacy study?
  • What type of inclusion/exclusion criteria are used for drug in a specific therapeutic areas [e.g., Viral Disease (e.g., HIV, Hepatitis C), Hepatology (e.g., Hepatic Encephalopathy), Gastrointestinal (e.g., Ulcerative Colitis, Irritable Bowel Syndrome, Chronic Constipation, Travelers’ Diarrhea), Cardiovascular (e.g., Anticoagulant, Coagulant), Infectious Disease, Dermatology (Dermal/Topical, Acne, Lice), Inflammatory Disease (e.g., Rheumatoid Arthritis), Hematology (e.g., Sickle Cell Disease, Leukemia), Oncology, Metabolic Diseases (e.g., Diabetes, Low Testosterone), Analgesia (e.g., Nociceptive, Neuropathic Pain, Breakthrough Cancer Pain), Pulmonary (e.g., COPD, Asthma, Pulmonary Hypertension), Anesthesia (e.g., Neuromuscular Blockers), Pediatric Diseases, CNS (e.g., Epilepsy, Depression, Parkinson’s Disease, Tourette’s Syndrome, Schizophrenia), Orphan Indications (e.g., Hereditary Inclusion Body Myopathy, Niemann Pick Type C]?

Be sure to read the next post in this series: Study Procedures 

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