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Completed

NCT Number: NCT02218294

Study to Determine How BCX4161 is Metabolized and Eliminated by the Body

The purpose of the study is to assess the extent that radioactive dose of BCX4161 taken by mouth ends up in the urine, feces and expired air. If there are metabolites of BCX4161 made by the body, the chemical composition of these metabolites and their profile over time in blood and urine will be determined.

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Key information

Conditions

Hereditary Angioedema Angioedema Angioedemas, Hereditary Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Complement Deficiency Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Vascular Diseases

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical Ltd

Ruddington, Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy males
  • Age 30 to 65 years of age (inclusive)
  • Body mass index of 18.0 to 32.0 kg/m2
  • Must be willing and able to communicate and participate in the whole study
  • Must provide written informed consent
  • A history of regular bowel movements
  • Must agree to use an adequate method of contraception

Key Exclusion Criteria:

  • Participation in a clinical research study within the previous 3 months
  • Current or history of any drug or alcohol abuse in the past 2 years or positive drugs of abuse screen
  • Current smokers
  • Radiation exposure, including that from the present study, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years
  • Clinically significant medical history, current medical or psychiatric condition, ECG finding, or laboratory/urinalysis abnormality
  • Activated partial thromboplastin time or PT outside of normal laboratory limits

Treatment and study plan

BCX4161

Drug

Primary outcomes

  1. Mass balance of BCX4161 after a single oral dose of [14C] BCX4161 based upon radioactivity excreted in urine, expired air and feces

    Time frame: Determined from samples drawn up to 14 days post-dose

Secondary outcomes

  1. Chemical structure elucidation of major metabolites of [14C] BCX4161 in urine, plasma, feces, urine

    Time frame: Determined from samples drawn up to 4 days post-dose

  2. Plasma pharmacokinetics (Cmax, Tmax, Tlag, AUC(0-last), AUC(0-inf), CL/F, Vz/F, AUC%extrapolated,t1/2, as applicable for each analyte) of total radioactivity, BCX4161, [14C] BCX4161 and major metabolites of [14C] BCX4161

    Time frame: Data generated from samples drawn up to 7 days post-dose

  3. Urinary pharmacokinetics (CLr, Ae, and % dose excreted) of BCX4161

    Time frame: Data generated from samples drawn up to 7 days post-dose

  4. Safety and tolerability evaluated through assessments of adverse events, laboratory analyses, vital signs, ECGs, and physical examinations

    Time frame: Over the duration of the study, approximately 6 weeks from screening through follow-up

Sponsors and collaborators

Lead sponsor

BioCryst Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1 Study to Evaluate the Absorption, Metabolism and Excretion of BCX4161 Following Administration of a Single, Oral Dose of [14C]-Radiolabelled BCX4161 to Healthy Male Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 18, 2014
Registry last updated
Oct 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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