Healthy VolunteersPhase 1NCT04953923
Thorough QT Assessment of Cedazuridine in Healthy Subjects
A Phase 1 study testing Cedazuridine and Moxifloxacin in people with Healthy Volunteers, run by Astex Pharmaceuticals, Inc. at 1 site in Netherlands.
Trial summary
This study is designed to evaluate the effect of therapeutic and supratherapeutic oral doses of cedazuridine on cardiac repolarization, as detected by QTc in healthy subjects, in accordance with regulatory guidelines. Moxifloxacin will be used to validate the study. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Cedazuridine and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2021to 16 Nov 2021
- 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
- Male or female who is not of childbearing potential
- Body mass index of 18.0 to 32.0 kg/m^2, inclusive
Who cannot join
- QTcF >450 msec at screening
- Clinically relevant abnormalities in conduction parameters; or if PR interval > 200 msec, QRS duration > 110 msec, or bradycardia or tachycardia (HR <45 bpm or >100 bpm)
- History or presence of hypokalemia, hypomagnesemia, or hypocalcemia
- Risk factors for Torsades de Pointes (TdP) (eg, congenital deafness, heart failure, cardiomyopathy, concomitant medications known to cause QTc prolongation) within a washout of at least 30 days
- Family history of Long QT Syndrome or family history of TdP
- Sick sinus syndrome, atrioventricular block (any degree)
Show all 10Show fewer
- Myocardial infarction, pulmonary congestion, cardiac arrhythmia, prolonged QT interval, or conduction abnormalities
- Repeated or frequent syncope or vasovagal episodes
- Resuscitated arrest possibly due to TdP; hypertension, angina, or severe peripheral arterial circulatory disorders
- Use of concomitant medications that prolong the QT/QTc interval
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blinded, Double-dummy, Placebo-controlled Thorough QTC Study With Single Oral Doses of Cedazuridine in Healthy Subjects
This study is designed to evaluate the effect of therapeutic and supratherapeutic oral doses of cedazuridine on cardiac repolarization, as detected by QTc in healthy subjects, in accordance with regulatory guidelines. Moxifloxacin will be used to validate the study. Study duration per participant is approximately 20 days.
- Conditions
- Healthy Volunteers
- Being tested
- Cedazuridine, Placebo, Moxifloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CedazuridineDrug
Tablet for oral administration
PlaceboDrug
Capsule for oral administration
MoxifloxacinDrug
Tablet for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Cedazuridine at a therapeutic dose Receives: Drug: Cedazuridine |
| Treatment B | Experimental | Cedazuridine at a supratherapeutic dose Receives: Drug: Cedazuridine |
| Treatment C | Placebo comparator | Placebo control Receives: Drug: Placebo |
| Treatment D | Active comparator | Moxifloxacin positive control Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in QTcF
Change from baseline in QTcF following single therapeutic and supratherapeutic doses of cedazuridine
Measured: Baseline and Day 20
Secondary outcomes (9)
Change from baseline in QTcF
Change from baseline in QTcF following cedazuridine-epimer and moxifloxacin administration
Measured: Baseline and Day 20
Safety: Participants with adverse events
Number of participants with adverse events following single therapeutic and supratherapeutic doses of cedazuridine
Measured: Up to Day 20
Change from baseline in heart rate
Change from baseline in heart rate following single therapeutic and supratherapeutic doses of cedazuridine
Measured: Baseline and Day 20
Change from baseline in PR interval of the electrocardiogram (ECG)
Change from baseline in PR interval of the ECG following single therapeutic and supratherapeutic doses of cedazuridine
Measured: Baseline and Day 20
Change from baseline in QRS interval of the electrocardiogram (ECG)
Change from baseline in QRS interval of the ECG following single therapeutic and supratherapeutic doses of cedazuridine
Measured: Baseline and Day 20
Change from baseline in T-wave morphology
Change from baseline in treatment-emergent T-wave morphology following single therapeutic and supratherapeutic doses of cedazuridine
Measured: Baseline to Day 20
Pharmacokinetic parameter: Cmax
Cmax is the maximum observed plasma concentration of cedazuridine, cedazuridine-epimer, and moxifloxacin
Measured: Up to Day 20
Pharmacokinetic parameter: Tmax
Tmax is the time to maximum observed plasma concentration of cedazuridine, cedazuridine-epimer, and moxifloxacin
Measured: Up to Day 20
Pharmacokinetic parameter: AUClast
Area under the curve (AUC) from time 0 to time of last measurable concentration of cedazuridine, cedazuridine-epimer, and moxifloxacin
Measured: Up to Day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Jul 2021
- Primary completion15 Nov 2021
- Study completion16 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astex Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953923
- Sponsor's protocol ID
- E7727-02
- Status last verified
- Aug 2024
- First submitted
- 30 Jun 2021
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Double-dummy, Placebo-controlled Thorough QTC Study With Single Oral Doses of Cedazuridine in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04953923
- Acronym / sponsor ID
- E7727-02
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Astex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 16 Nov 2021 (actual)
- First posted
- 8 Jul 2021 (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 study is designed to evaluate the effect of therapeutic and supratherapeutic oral doses of cedazuridine on cardiac repolarization, as detected by QTc in healthy subjects, in accordance with regulatory guidelines. Moxifloxacin will be used to validate the study. Study duration per participant is approximately 20 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: CedazuridineCedazuridine at a therapeutic dose |
| Treatment B | Experimental | Drug: CedazuridineCedazuridine at a supratherapeutic dose |
| Treatment C | Placebo comparator | Drug: PlaceboPlacebo control |
| Treatment D | Active comparator | Drug: MoxifloxacinMoxifloxacin positive control |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male or female who is not of childbearing potential
- Body mass index of 18.0 to 32.0 kg/m^2, inclusive
Key exclusion criteria (10 listed)
- QTcF >450 msec at screening
- Clinically relevant abnormalities in conduction parameters; or if PR interval > 200 msec, QRS duration > 110 msec, or bradycardia or tachycardia (HR <45 bpm or >100 bpm)
- History or presence of hypokalemia, hypomagnesemia, or hypocalcemia
- Risk factors for Torsades de Pointes (TdP) (eg, congenital deafness, heart failure, cardiomyopathy, concomitant medications known to cause QTc prolongation) within a washout of at least 30 days
- Family history of Long QT Syndrome or family history of TdP
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 |
|---|---|---|
| CedazuridineTablet for oral administration | Drug | Treatment A, Treatment B |
| PlaceboCapsule for oral administration | Drug | Treatment C |
| MoxifloxacinTablet for oral administration | Drug | Treatment D |
Primary outcome
Change from baseline in QTcF
Time frame: Baseline and Day 20
Change from baseline in QTcF following single therapeutic and supratherapeutic doses of cedazuridine
9 secondary outcomes
Change from baseline in QTcF
Time frame: Baseline and Day 20
Safety: Participants with adverse events
Time frame: Up to Day 20
Change from baseline in heart rate
Time frame: Baseline and Day 20
Change from baseline in PR interval of the electrocardiogram (ECG)
Time frame: Baseline and Day 20
Change from baseline in QRS interval of the electrocardiogram (ECG)
Time frame: Baseline and Day 20
Change from baseline in T-wave morphology
Time frame: Baseline to Day 20
Pharmacokinetic parameter: Cmax
Time frame: Up to Day 20
Pharmacokinetic parameter: Tmax
Time frame: Up to Day 20
Pharmacokinetic parameter: AUClast
Time frame: Up to Day 20
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 2 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cedazuridine and Moxifloxacin in people with Healthy Volunteers, run by Astex Pharmaceuticals, Inc. at 1 site in Netherlands.
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 2 inclusion and 10 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 2 Aug 2024. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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?
Change from baseline in QTcF (time frame: Baseline and Day 20). 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 2 Aug 2024.