Hereditary AngioedemaPhase 1NCT02125162
A Study of the Relative Bioavailability of a New Formulation of BCX4161 and the Effect of Food on BCX4161
A Phase 1 study testing BCX4161 in people with Hereditary Angioedema, run by BioCryst Pharmaceuticals at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hereditary Angioedema
- What is being tested?
- BCX4161
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to Jul 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Clinical Ltd
Ruddington, Nottingham, NG11 6JS
About this study
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
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.
- Conditions
- Hereditary Angioedema
- Being tested
- BCX4161
- Keywords
- BCX4161, BioCryst, hereditary angioedema, relative bioavailability, kallikrein inhibitor
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCX4161Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | BCX4161 400 mg formulated as hard gelatin capsules given orally under fasting conditions x1 Receives: Drug: BCX4161 |
| Treatment B | Experimental | BCX4161 400 mg formulated as soft gelatin capsules given orally under fasting conditions x1 Receives: Drug: BCX4161 |
| Treatment C | Experimental | BCX4161 400 mg formulated as soft gelatin capsules given orally after a high-fat breakfast x1 Receives: Drug: BCX4161 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma pharmacokinetics to assess the relative bioavailability of BCX4161 soft gelatin capsules to hard gelatin capsules
Measured: Pharmacokinetic parameters AUC0-inf, AUC0-t and Cmax generated after 24 hours of postdose blood sampling
Secondary outcomes (2)
Safety and tolerability evaluated through assessments of adverse events, laboratory analyses, vital signs, ECGs, and physical examinations
Measured: Screening through study completion (approximately 61 days)
Plasma pharmacokinetics to assess the effect of food on BCX4161
Measured: Pharmacokinetic parameters AUC0-inf, AUC0-t and Cmax generated after 24 hours of postdose blood sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary AngioedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioCryst Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joanne Collier, Principal investigator, Quotient Clinical Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125162
- Sponsor's protocol ID
- BCX4161-104
- Status last verified
- Aug 2014
- First submitted
- 24 Apr 2014
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02125162
- Acronym / sponsor ID
- BCX4161-104
- Conditions
- Hereditary Angioedema
- Keywords
- BCX4161, BioCryst, hereditary angioedema, relative bioavailability, kallikrein inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- BioCryst PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 29 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: BCX4161BCX4161 400 mg formulated as hard gelatin capsules given orally under fasting conditions x1 |
| Treatment B | Experimental | Drug: BCX4161BCX4161 400 mg formulated as soft gelatin capsules given orally under fasting conditions x1 |
| Treatment C | Experimental | Drug: BCX4161BCX4161 400 mg formulated as soft gelatin capsules given orally after a high-fat breakfast x1 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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 (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCX4161Each 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 | Drug | Treatment A, Treatment B, Treatment C |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
Related trials for Hereditary Angioedema
RecruitingPhase 3
Donidalorsen Treatment in Children With Hereditary Angioedema
Hereditary Angioedema (HAE)
RecruitingObservational study
A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea
Hereditary Angioedema (HAE)
Active, not recruitingPhase 3
HAELO: A Phase 3 Study to Evaluate NTLA-2002 in Participants With Hereditary Angioedema (HAE)
Hereditary Angioedema
RecruitingPhase 3
Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks
Acute Hereditary Angio Edema
Active, not recruitingPhase 1/2
NTLA-2002 in Adults With Hereditary Angioedema (HAE)
Hereditary Angioedema
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne Collier principal investigator
Quotient Clinical Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BCX4161 in people with Hereditary Angioedema, run by BioCryst Pharmaceuticals at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2014.