Hereditary Angioedema Clinical Trial
Official title:
A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of BCX7353 in Healthy Subjects
This is a 3-part Phase 1 dose-ranging study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single (Part 1) and multiple (Part 2) ascending doses of BCX7353 in healthy subjects, and single and multiple doses of BCX7353 in healthy Japanese subjects. Pharmacokinetics is an analysis of how the body handles the study drug BCX7353 and pharmacodynamics is an analysis of the activity the study drug BCX7353 may have in the body.
Status | Completed |
Enrollment | 122 |
Est. completion date | December 2015 |
Est. primary completion date | November 2015 |
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 - Abides by study restrictions - Attends all study visits and agrees to remain in study center for the confinement period - Acceptable birth control measures for male subjects and women of childbearing potential - Part 3 only: Japanese subjects enrolled in Part 3 must be first generation: born in Japan, not having lived outside Japan > 5 years, able to trace maternal and paternal Japanese ancestry, with no significant change in lifestyle, including diet (at least one Japanese meal consumed per day), since leaving Japan. Key Exclusion Criteria: - Clinically significant medical history, current medical or psychiatric condition. This includes a history of clinically significant gastrointestinal, hematologic, renal, hepatic, bronchopulmonary, neurological, or cardiac disease - Clinically significant ECG finding, vital sign measurement or laboratory/urinalysis abnormality at screening or baseline - Use of over the counter medication within 7 days of dosing and anticipated use through the follow-up visit - Use of prescription medication within 14 days of dosing and anticipated use through the follow-up visit - Participation in any other investigational drug study within 90 days of screening - Recent or current history of alcohol or drug abuse - Regular recent use of tobacco or nicotine products - Positive serology for HBV, HCV, or HIV - Pregnant or nursing - Donation or loss of greater than 400 mL of blood within 3 months - Serious adverse reaction or serious hypersensitivity to any drug |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Quotient Clinical | Ruddington |
Lead Sponsor | Collaborator |
---|---|
BioCryst Pharmaceuticals |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse events | Part 1 and Part 3 single dose cohort: absolute and change from baseline through Study Day 7; Part 2 and Part 3 multiple dose cohort: absolute and change from baseline through 14 or 21 days (depending on dosing duration) | Yes | |
Primary | Laboratory analyses | Part 1 and Part 3 single dose cohort: absolute and change from baseline through Study Day 7; Part 2 and Part 3 multiple dose cohort: absolute and change from baseline through 14 or 21 days (depending on dosing duration) | Yes | |
Primary | Vital signs | Part 1 and Part 3 single dose cohort: absolute and change from baseline through Study Day 7; Part 2 and Part 3 multiple dose cohort: absolute and change from baseline through 14 or 21 days (depending on dosing duration) | Yes | |
Primary | Electrocardiograms | Part 1 and Part 3 single dose cohort: absolute and change from baseline through Study Day 7; Part 2 and Part 3 multiple dose cohort: absolute and change from baseline through 14 or 21 days (depending on dosing duration) | Yes | |
Primary | Physical examination findings | Part 1 and Part 3 single dose cohort: absolute and change from baseline through Study Day 7; Part 2 and Part 3 multiple dose cohort: absolute and change from baseline through 14 or 21 days (depending on dosing duration) | Yes | |
Secondary | Plasma BCX7353 Cmax | plasma pharmacokinetic parameters are based on blood sampling through Day 5 for Part 1 and Part 3 single dose cohort and through Day 14 or 21 for Part 2 and Part 3 multiple dose cohort (Day depends on dosing duration) | No | |
Secondary | Plasma BCX7353 Tmax | plasma pharmacokinetic parameters are based on blood sampling through Day 5 for Part 1 and Part 3 single dose cohort and through Day 14 or 21 for Part 2 and Part 3 multiple dose cohort (Day depends on dosing duration) | No | |
Secondary | Plasma BCX7353 average steady-state concentration | steady-state plasma pharmacokinetic parameters are based on blood sampling through Day 14 or 21 for Part 2 and Part 3 multiple dose cohort (Day depends on dosing duration) | No | |
Secondary | Plasma BCX7353 AUCinf | plasma pharmacokinetic parameters are based on blood sampling through Day 5 for Part 1 and Part 3 single dose cohort | No | |
Secondary | Plasma BCX7353 AUCtau | steady-state plasma pharmacokinetic parameters are based on blood sampling through Day 14 or 21 for Part 2 and Part 3 multiple dose cohort (Day depends on dosing duration) | No | |
Secondary | Plasma BCX7353 AUC0-t | plasma pharmacokinetic parameters are based on blood sampling through Day 5 for Part 1 and Part 3 single dose cohort and through Day 14 or 21 for Part 2 and Part 3 multiple dose cohort (Day depends on dosing duration) | No | |
Secondary | Plasma BCX7353 t1/2 | plasma pharmacokinetic parameters are based on blood sampling through Day 5 for Part 1 and Part 3 single dose cohort and through Day 14 or 21 for Part 2 and Part 3 multiple dose cohort (Day depends on dosing duration) | No | |
Secondary | Plasma BCX7353 apparent oral clearance | plasma pharmacokinetic parameters are based on blood sampling through Day 5 for Part 1 and Part 3 single dose cohort and through Day 14 or 21 for Part 2 and Part 3 multiple dose cohort (Day depends on dosing duration) | No | |
Secondary | Plasma BCX7353 apparent volume of distribution | plasma pharmacokinetic parameters are based on blood sampling through Day 5 for Part 1 and Part 3 single dose cohort and through Day 14 or 21 for Part 2 and Part 3 multiple dose cohort (Day depends on dosing duration) | No | |
Secondary | Plasma BCX7353 accumulation ratio | steady-state plasma pharmacokinetic parameters are based on blood sampling through Day 14 or 21 for Part 2 and Part 3 multiple dose cohort (Day depends on dosing duration) | No | |
Secondary | Plasma pharmacodynamics of BCX7353 | Outcome evaluated by change from baseline in ex vivo kallikrein inhibition | plasma pharmacokinetic parameters are based on blood sampling through Day 5 for Part 1 and Part 3 single dose cohort and through Day 14 or 21 for Part 2 and Part 3 multiple dose cohort (Day depends on dosing duration) | No |
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