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NCT02125162 Clinical Trial

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

Hereditary Angioedema Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02125162
Other study ID # BCX4161-104
Secondary ID
Status Completed
Phase Phase 1
First received April 24, 2014
Last updated August 14, 2014
Start date April 2014
Est. completion date July 2014

Study information
Verified date August 2014
Source BioCryst Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United Kingdom Quotient Clinical Ltd Ruddington Nottingham

Sponsors (1)
Lead Sponsor Collaborator
BioCryst Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma pharmacokinetics to assess the relative bioavailability of BCX4161 soft gelatin capsules to hard gelatin capsules Pharmacokinetic parameters AUC0-inf, AUC0-t and Cmax generated after 24 hours of postdose blood sampling No
Secondary Safety and tolerability evaluated through assessments of adverse events, laboratory analyses, vital signs, ECGs, and physical examinations Screening through study completion (approximately 61 days) No
Secondary Plasma pharmacokinetics to assess the effect of food on BCX4161 Pharmacokinetic parameters AUC0-inf, AUC0-t and Cmax generated after 24 hours of postdose blood sampling No
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