Hereditary AngioedemaPhase 1NCT03202784
A Relative Bioavailability Study of Two Formulations of BCX7353
A Phase 1 study testing BCX7353 in people with Hereditary Angioedema, run by BioCryst Pharmaceuticals at 1 site in United Kingdom.
Trial summary
This is an open-label, randomized study to investigate the relative bioavailability of two formulations of BCX7353 and to determine if there is a food effect Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hereditary Angioedema
- What is being tested?
- BCX7353
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Feb 2017to 30 Sep 2017
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- written informed consent
- acceptable birth control measures for male subjects and women of childbearing potential
- complies with all required study procedures and restrictions
Who cannot join
- clinically significant medical history, current medical or psychiatric condition
- clinically significant ECG finding, vital sign measurement or laboratory/urinalysis abnormality at screening or baseline
- current use, or use of any prescribed or over the counter medication, vitamins or herbal products within 14 days of Day 1
- 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
Show all 9Show fewer
- positive serology for HBV, HCV, or HIV
- pregnant or nursing
- donation or loss of greater than 400 mL of blood within the previous 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-Dose, 3-Period Crossover Study to Evaluate the Relative Bioavailability of Two BCX7353 Capsule Formulations and to Evaluate the Effect of Food on BCX7353 Pharmacokinetics in Healthy Subjects
This is an open-label, randomized study to investigate the relative bioavailability of two formulations of BCX7353 and to determine if there is a food effect
Read the detailed description
In this study, 24 healthy subjects will be randomized to receive a single dose of two formulations of BCX7353 and one of the formulations administered with a high-fat meal. A 14-day washout period will separate each dose.
- Conditions
- Hereditary Angioedema
- Being tested
- BCX7353
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCX7353Drug
BCX7353
| Study group | Role | What they receive |
|---|---|---|
| BCX7353 API in capsule | Experimental | fasted administration of BCX7353 API in capsule Receives: Drug: BCX7353 |
| BCX7353 blend in capsule | Experimental | fasted administration of BCX7353 blend in capsule Receives: Drug: BCX7353 |
| BCX7353 blend in capsule with food | Experimental | administration of BCX7353 blend in capsule following high-fat meal Receives: Drug: BCX7353 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric least-squares mean ratio for Cmax for test (blend in capsule) versus reference formulation (API in capsule)
Measured: plasma pharmacokinetic parameters are based on blood sampling over a 72 hour period
Geometric least-squares mean ratio for AUClast for test (blend in capsule) versus reference formulation (API in capsule)
Measured: plasma pharmacokinetic parameters are based on blood sampling over a 72 hour period
Geometric least-squares mean ratio for AUCinf for test (blend in capsule) versus reference formulation (API in capsule)
Measured: plasma pharmacokinetic parameters are based on blood sampling over a 72 hour period
Geometric least-squares mean ratio for Cmax for test (blend in capsule fed) versus reference formulation (blend in capsule fasted)
Measured: lasma pharmacokinetic parameters are based on blood sampling over a 72 hour period
Geometric least-squares mean ratio for AUClast for test (blend in capsule fed) versus reference formulation (blend in capsule fasted)
Measured: lasma pharmacokinetic parameters are based on blood sampling over a 72 hour period
Geometric least-squares mean ratio for AUCinf for test (blend in capsule fed) versus reference formulation (blend in capsule fasted)
Measured: lasma pharmacokinetic parameters are based on blood sampling over a 72 hour period
Secondary outcomes (5)
adverse events
Measured: absolute and change from baseline through end of study, approximately 35 days
laboratory analyses
Measured: absolute and change from baseline through end of study, approximately 35 days
vital signs
Measured: absolute and change from baseline through end of study, approximately 35 days
physical examination findings
Measured: absolute and change from baseline through end of study, approximately 35 days
electrocardiograms
Measured: absolute and change from baseline through end of study, approximately 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start27 Feb 2017
- Primary completion1 Aug 2017
- Study completion30 Sep 2017
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
- Model description
- Three way crossover to evaluate two formulations of BCX7353 and to determine if there is a food effect
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioCryst Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Litza McKenzie, MBChB, BScMedSci, Principal investigator, Quotient Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202784
- Sponsor's protocol ID
- BCX7353-103
- Status last verified
- Oct 2017
- First submitted
- 27 Jun 2017
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Dose, 3-Period Crossover Study to Evaluate the Relative Bioavailability of Two BCX7353 Capsule Formulations and to Evaluate the Effect of Food on BCX7353 Pharmacokinetics in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03202784
- Acronym / sponsor ID
- BCX7353-103
- Conditions
- Hereditary Angioedema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BioCryst PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 29 Jun 2017 (actual)
- 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.
This is an open-label, randomized study to investigate the relative bioavailability of two formulations of BCX7353 and to determine if there is a food effect
Detailed description
In this study, 24 healthy subjects will be randomized to receive a single dose of two formulations of BCX7353 and one of the formulations administered with a high-fat meal. A 14-day washout period will separate each dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three way crossover to evaluate two formulations of BCX7353 and to determine if there is a food effect
| Arm | Type | Receives |
|---|---|---|
| BCX7353 API in capsule | Experimental | Drug: BCX7353fasted administration of BCX7353 API in capsule |
| BCX7353 blend in capsule | Experimental | Drug: BCX7353fasted administration of BCX7353 blend in capsule |
| BCX7353 blend in capsule with food | Experimental | Drug: BCX7353administration of BCX7353 blend in capsule following high-fat meal |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- written informed consent
- acceptable birth control measures for male subjects and women of childbearing potential
- complies with all required study procedures and restrictions
Key exclusion criteria (9 listed)
- clinically significant medical history, current medical or psychiatric condition
- clinically significant ECG finding, vital sign measurement or laboratory/urinalysis abnormality at screening or baseline
- current use, or use of any prescribed or over the counter medication, vitamins or herbal products within 14 days of Day 1
- participation in any other investigational drug study within 90 days of screening
- recent or current history of alcohol or drug abuse
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 |
|---|---|---|
| BCX7353BCX7353 | Drug | BCX7353 API in capsule, BCX7353 blend in capsule, BCX7353 blend in capsule with food |
Primary outcome
Geometric least-squares mean ratio for Cmax for test (blend in capsule) versus reference formulation (API in capsule)
Time frame: plasma pharmacokinetic parameters are based on blood sampling over a 72 hour period
Geometric least-squares mean ratio for AUClast for test (blend in capsule) versus reference formulation (API in capsule)
Time frame: plasma pharmacokinetic parameters are based on blood sampling over a 72 hour period
Geometric least-squares mean ratio for AUCinf for test (blend in capsule) versus reference formulation (API in capsule)
Time frame: plasma pharmacokinetic parameters are based on blood sampling over a 72 hour period
Geometric least-squares mean ratio for Cmax for test (blend in capsule fed) versus reference formulation (blend in capsule fasted)
Time frame: lasma pharmacokinetic parameters are based on blood sampling over a 72 hour period
Geometric least-squares mean ratio for AUClast for test (blend in capsule fed) versus reference formulation (blend in capsule fasted)
Time frame: lasma pharmacokinetic parameters are based on blood sampling over a 72 hour period
Geometric least-squares mean ratio for AUCinf for test (blend in capsule fed) versus reference formulation (blend in capsule fasted)
Time frame: lasma pharmacokinetic parameters are based on blood sampling over a 72 hour period
5 secondary outcomes
adverse events
Time frame: absolute and change from baseline through end of study, approximately 35 days
laboratory analyses
Time frame: absolute and change from baseline through end of study, approximately 35 days
vital signs
Time frame: absolute and change from baseline through end of study, approximately 35 days
physical examination findings
Time frame: absolute and change from baseline through end of study, approximately 35 days
electrocardiograms
Time frame: absolute and change from baseline through end of study, approximately 35 days
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 27 Jan 2020.
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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.
Litza McKenzie, MBChB, BScMedSci principal investigator
Quotient Clinical
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 BCX7353 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 3 inclusion and 9 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 27 Jan 2020. 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?
Geometric least-squares mean ratio for Cmax for test (blend in capsule) versus reference formulation (API in capsule) (time frame: plasma pharmacokinetic parameters are based on blood sampling over a 72 hour period). The study lists 6 primary outcomes in all. 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 27 Jan 2020.