A Phase 1 interventional study of BCX4161 in Hereditary Angioedema, sponsored by BioCryst Pharmaceuticals. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-15.
Sponsored by BioCryst Pharmaceuticals · Phase 1, Interventional, and Treatment
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.
164 studies on the registry are indexed under Angioedema; 19 are open to participants now.
This study's enrollment of 28 is below the median of 44 across 111 interventional studies indexed under Angioedema.
Browse Angioedema studies →BioCryst Pharmaceuticals is the lead sponsor of 54 studies on the registry; 2 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
BCX4161 400 mg formulated as hard gelatin capsules given orally under fasting conditions x1
Drug: BCX4161
BCX4161 400 mg formulated as soft gelatin capsules given orally under fasting conditions x1
Drug: BCX4161
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
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
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)
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
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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BioCryst Pharmaceuticals