A Study of the Relative Bioavailability of a New Formulation of BCX4161 and the Effect of Food on BCX4161

August 14, 2014 updated by: BioCryst Pharmaceuticals

A Single-dose, Randomized, 3-period, Crossover Study to Evaluate the Relative Bioavailability of BCX4161 Formulated as a Soft Gelatin Capsule to BCX4161 Formulated as a Hard Gelatin Capsule and the Effect of Food on BCX4161 Pharmacokinetics

The purpose of the study is to compare how the body takes up and then eliminates the study drug BCX4161 when it is taken orally as a hard gelatin capsule and as a soft gelatin capsule. This study will also evaluate whether food has any effect on how the body takes up BCX4161.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

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

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Written informed consent
  • Body mass index 19 to 32 kg/m2 and a weight of at least 50 kg
  • Abide by study restrictions
  • Attend all study visits
  • Acceptable birth control measures

Key Exclusion Criteria:

  • Clinically significant medical history, current medical or psychiatric condition, ECG finding, or laboratory/urinalysis abnormality
  • Activated partial thromboplastin time or prothrombin time outside of normal laboratory limits
  • Pregnant or nursing
  • Recent history of alcohol abuse or positive drugs of abuse screen
  • Current smokers
  • Donation or loss of greater than 400 mL of blood within 3 months

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment A
BCX4161 400 mg formulated as hard gelatin capsules given orally under fasting conditions x1
Drug: BCX4161
Each subject will receive Treatments A, B, and C in an open-label, randomized sequence with a washout period of at least 7 days between each dose
Experimental: Treatment B
BCX4161 400 mg formulated as soft gelatin capsules given orally under fasting conditions x1
Drug: BCX4161
Each subject will receive Treatments A, B, and C in an open-label, randomized sequence with a washout period of at least 7 days between each dose
Experimental: Treatment C
BCX4161 400 mg formulated as soft gelatin capsules given orally after a high-fat breakfast x1
Drug: BCX4161
Each subject will receive Treatments A, B, and C in an open-label, randomized sequence with a washout period of at least 7 days between each dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma pharmacokinetics to assess the relative bioavailability of BCX4161 soft gelatin capsules to hard gelatin capsules
Time Frame: Pharmacokinetic parameters AUC0-inf, AUC0-t and Cmax generated after 24 hours of postdose blood sampling
Pharmacokinetic parameters AUC0-inf, AUC0-t and Cmax generated after 24 hours of postdose blood sampling

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability evaluated through assessments of adverse events, laboratory analyses, vital signs, ECGs, and physical examinations
Time Frame: Screening through study completion (approximately 61 days)
Screening through study completion (approximately 61 days)
Plasma pharmacokinetics to assess the effect of food on BCX4161
Time Frame: Pharmacokinetic parameters AUC0-inf, AUC0-t and Cmax generated after 24 hours of postdose blood sampling
Pharmacokinetic parameters AUC0-inf, AUC0-t and Cmax generated after 24 hours of postdose blood sampling

Collaborators and Investigators

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

Sponsor

BioCryst Pharmaceuticals

Investigators

  • Principal Investigator: Joanne Collier, 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

April 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

April 24, 2014

First Submitted That Met QC Criteria

April 25, 2014

First Posted (Estimate)

April 29, 2014

Study Record Updates

Last Update Posted (Estimate)

August 15, 2014

Last Update Submitted That Met QC Criteria

August 14, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCX4161-104

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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