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

October 27, 2014 updated by: BioCryst Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Nottingham
      • Ruddington, Nottingham, United Kingdom, NG11 6JS
        • Quotient Clinical LTD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Key Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [14C] BCX4161
Includes a radiolabelled dose of [14C] BCX4161 and unlabelled BCX4161
Drug: BCX4161

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Determined from samples drawn up to 14 days post-dose

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Determined from samples drawn up to 4 days post-dose
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
Data generated from samples drawn up to 7 days post-dose
Urinary pharmacokinetics (CLr, Ae, and % dose excreted) of BCX4161
Time Frame: Data generated from samples drawn up to 7 days post-dose
Data generated from samples drawn up to 7 days post-dose
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
Over the duration of the study, approximately 6 weeks from screening through follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioCryst Pharmaceuticals

Investigators

  • Principal Investigator: Joanne Collier, MBChB, FFPM, Dip Stats (OU), Quotient Clinical LTD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

August 14, 2014

First Submitted That Met QC Criteria

August 14, 2014

First Posted (Estimate)

August 18, 2014

Study Record Updates

Last Update Posted (Estimate)

October 29, 2014

Last Update Submitted That Met QC Criteria

October 27, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCX4161-103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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