Hereditary AngioedemaPhase 1NCT03136237
A Drug-Drug Interaction Study to Evaluate Drug Transporter Interactions
A Phase 1 study testing BCX7353, Digoxin and BCX7353 + digoxin in people with Hereditary Angioedema, run by BioCryst Pharmaceuticals at 1 site in United Kingdom.
Trial summary
This is an open-label, three part study to evaluate the effect of BCX7353 on drug transporters as well as the effect of an inhibitor of drug transport on BCX7353. 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, Digoxin and BCX7353 + digoxin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Feb 2017to 15 Aug 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
- creatinine clearance of at least 80 mL/min by Cockcroft-Gault equation
- 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
- use of medication that is known to inhibit or induce metabolic enzymes or transporters within 30 days of dosing
- participation in any other investigational drug study within 90 days of screening
- recent or current history of alcohol or drug abuse
Show all 12Show fewer
- 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 the previous 3 months
- history of severe hypersensitivity to any medicinal product
- for subjects enrolled in cohort 1, current use of antibiotics or probiotics, or use within 6 months prior to Day 1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Evaluate the Effect of BCX7353 on the Single Dose Pharmacokinetics of the P-gp Substrate Digoxin and the BCRP Substrate Rosuvastatin and the Effect of the P-gp Inhibitor Cyclosporine on the Single Dose Pharmacokinetics of BCX7353
This is an open-label, three part study to evaluate the effect of BCX7353 on drug transporters as well as the effect of an inhibitor of drug transport on BCX7353.
Read the detailed description
This is a single center, open-label, fixed-sequence, drug interaction study to evaluate the effect of BCX7353 on the pharmacokinetics of the P-gp substrate digoxin and the BCRP substrate rosuvastatin, as well as the effect of the P-gp inhibitor cyclosporine on the pharmacokinetics of BCX7353.
It is planned that 54 subjects will be enrolled into 3 cohorts of 18 subjects each. Cohort 1 will evaluate the effects of multiple doses of BCX7353 on single-dose pharmacokinetics of digoxin. Cohort 2 will evaluate the effect of multiple doses of BCX7353 on the pharmacokinetics of rosuvastatin. Cohort 3 will evaluate the effect of a single dose of cyclosporine on the pharmacokinetics of BCX7353. Cohorts may be dosed in parallel or in any order.
- Conditions
- Hereditary Angioedema
- Being tested
- BCX7353, Digoxin, BCX7353 + digoxin, Rosuvastatin, rosuvastatin + 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
Day 11-18 for Cohort 1, Day 7-14 for Cohort 2, Day 1 for Cohort 3
DigoxinDrug
Day 1 of Cohort 1
BCX7353 + digoxinDrug
Day 19 of Cohort 1
RosuvastatinDrug
Day 1 of Cohort 2
rosuvastatin + BCX7353Drug
Day 15 of Cohort 1
Cyclosporine + BCX7353Drug
Day 14 of Cohort 3
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Day 1: Digoxin 0.25 mg oral dose Day 11-18: BCX7353 350 mg oral dose Day 19: Digoxin 0.25 mg oral dose and BCX7353 350 mg oral dose Day 20-21: BCX7353 350 mg oral dose Receives: Drug: BCX7353; Drug: Digoxin; Drug: BCX7353 + digoxin |
| Cohort 2 | Experimental | Day 1: Rosuvastatin 10 mg oral dose Day 7-14: BCX7353 350 mg oral dose Day 15: Rosuvastatin 10 mg oral dose and BCX7353 350 mg oral dose Day 16: BCX7353 350 mg oral dose Receives: Drug: BCX7353; Drug: Rosuvastatin; Drug: rosuvastatin + BCX7353 |
| Cohort 3 | Experimental | Day 1: BCX7353 350 mg oral dose Day 14: single oral dose of Cyclosporine 600 mg and BCX7353 350 mg Receives: Drug: BCX7353; Drug: Cyclosporine + BCX7353 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of probe substrate
Measured: plasma pharmacokinetic parameters are based on blood sampling over a 48 - 72 hour period
AUClast of probe substrate
Measured: plasma pharmacokinetic parameters are based on blood sampling over a 48 - 72 hour period
AUCinf of probe substrate
Measured: plasma pharmacokinetic parameters are based on blood sampling over a 48 - 72 hour period
Secondary outcomes (5)
adverse events
Measured: absolute and change from baseline through end of study, approximately 30 days
laboratory analyses
Measured: absolute and change from baseline through end of study, approximately 30 days
vital signs
Measured: absolute and change from baseline through end of study, approximately 30 days
physical examination findings
Measured: absolute and change from baseline through end of study, approximately 30 days
electrocardiograms
Measured: absolute and change from baseline throughend of study, approximately 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start17 Feb 2017
- Primary completion15 Aug 2017
- Study completion15 Aug 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 3 parallel treatment assessments
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioCryst Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Firas Almazedi, MBChB, Msc, CPI, Principal investigator, Covance Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136237
- Sponsor's protocol ID
- BCX7353-105
- Status last verified
- Oct 2017
- First submitted
- 24 Apr 2017
- Last updated
- 26 Oct 2017
- 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 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Effect of BCX7353 on the Single Dose Pharmacokinetics of the P-gp Substrate Digoxin and the BCRP Substrate Rosuvastatin and the Effect of the P-gp Inhibitor Cyclosporine on the Single Dose Pharmacokinetics of BCX7353
- ClinicalTrials.gov ID
- NCT03136237
- Acronym / sponsor ID
- BCX7353-105
- Conditions
- Hereditary Angioedema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- BioCryst PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 2 May 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, three part study to evaluate the effect of BCX7353 on drug transporters as well as the effect of an inhibitor of drug transport on BCX7353.
Detailed description
This is a single center, open-label, fixed-sequence, drug interaction study to evaluate the effect of BCX7353 on the pharmacokinetics of the P-gp substrate digoxin and the BCRP substrate rosuvastatin, as well as the effect of the P-gp inhibitor cyclosporine on the pharmacokinetics of BCX7353.
It is planned that 54 subjects will be enrolled into 3 cohorts of 18 subjects each. Cohort 1 will evaluate the effects of multiple doses of BCX7353 on single-dose pharmacokinetics of digoxin. Cohort 2 will evaluate the effect of multiple doses of BCX7353 on the pharmacokinetics of rosuvastatin. Cohort 3 will evaluate the effect of a single dose of cyclosporine on the pharmacokinetics of BCX7353. Cohorts may be dosed in parallel or in any order.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 parallel treatment assessments
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: BCX7353, Drug: Digoxin, Drug: BCX7353 + digoxinDay 1: Digoxin 0.25 mg oral dose Day 11-18: BCX7353 350 mg oral dose Day 19: Digoxin 0.25 mg oral dose and BCX7353 350 mg oral dose Day 20-21: BCX7353 350 mg oral dose |
| Cohort 2 | Experimental | Drug: BCX7353, Drug: Rosuvastatin, Drug: rosuvastatin + BCX7353Day 1: Rosuvastatin 10 mg oral dose Day 7-14: BCX7353 350 mg oral dose Day 15: Rosuvastatin 10 mg oral dose and BCX7353 350 mg oral dose Day 16: BCX7353 350 mg oral dose |
| Cohort 3 | Experimental | Drug: BCX7353, Drug: Cyclosporine + BCX7353Day 1: BCX7353 350 mg oral dose Day 14: single oral dose of Cyclosporine 600 mg and BCX7353 350 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- written informed consent
- acceptable birth control measures for male subjects and women of childbearing potential
- creatinine clearance of at least 80 mL/min by Cockcroft-Gault equation
- complies with all required study procedures and restrictions
Key exclusion criteria (12 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
- use of medication that is known to inhibit or induce metabolic enzymes or transporters within 30 days of dosing
- participation in any other investigational drug study within 90 days of screening
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 |
|---|---|---|
| BCX7353Day 11-18 for Cohort 1, Day 7-14 for Cohort 2, Day 1 for Cohort 3 | Drug | Cohort 1, Cohort 2, Cohort 3 |
| DigoxinDay 1 of Cohort 1 | Drug | Cohort 1 |
| BCX7353 + digoxinDay 19 of Cohort 1 | Drug | Cohort 1 |
| RosuvastatinDay 1 of Cohort 2 | Drug | Cohort 2 |
| rosuvastatin + BCX7353Day 15 of Cohort 1 | Drug | Cohort 2 |
| Cyclosporine + BCX7353Day 14 of Cohort 3 | Drug | Cohort 3 |
Primary outcome
Cmax of probe substrate
Time frame: plasma pharmacokinetic parameters are based on blood sampling over a 48 - 72 hour period
AUClast of probe substrate
Time frame: plasma pharmacokinetic parameters are based on blood sampling over a 48 - 72 hour period
AUCinf of probe substrate
Time frame: plasma pharmacokinetic parameters are based on blood sampling over a 48 - 72 hour period
5 secondary outcomes
adverse events
Time frame: absolute and change from baseline through end of study, approximately 30 days
laboratory analyses
Time frame: absolute and change from baseline through end of study, approximately 30 days
vital signs
Time frame: absolute and change from baseline through end of study, approximately 30 days
physical examination findings
Time frame: absolute and change from baseline through end of study, approximately 30 days
electrocardiograms
Time frame: absolute and change from baseline throughend of study, approximately 30 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 26 Oct 2017.
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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.
Firas Almazedi, MBChB, Msc, CPI principal investigator
Covance 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, Digoxin and BCX7353 + digoxin 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 4 inclusion and 12 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 26 Oct 2017. 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?
Cmax of probe substrate (time frame: plasma pharmacokinetic parameters are based on blood sampling over a 48 - 72 hour period). The study lists 3 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 26 Oct 2017.