HealthyPhase 1NCT02537288
A Study in Healthy Volunteers to Assess the Effect of Fedovapagon on the QT/QTC Interval
A Phase 1 study testing Fedovapagon and Moxifloxacin in people with Healthy, run by Vantia Ltd at 1 site in Germany.
Trial summary
The purpose of this study is to assess the electrocardiogram (ECG) effects of fedovapagon dose administration relative to placebo in healthy adult male and female subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fedovapagon and Moxifloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2015to Dec 2015
- 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
- Provide signed and dated informed consent before any study-specific procedures are conducted.
- Healthy males and females 18 to 55 years of age (inclusive).
- No clinically significant abnormal physical findings.
- No clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or admission.
- Have a body mass index (BMI) ≥18.0 to ≤29.9 kg/m2 (weight: ≥50 kg and ≤100 kg) at the Screening visit.
- Be judged by the Investigator to be in good health based on medical history, physical examination, vital sign measurements and laboratory safety tests performed at the Screening visit and before the first administration of fedovapagon, moxifloxacin or placebo.
Show all 14Show fewer
- Have no clinically significant abnormality on an ECG performed at the Screening visit and on admission to the study center.
- Have a normal resting blood pressure.
- Must be able to understand and be willing to comply with study procedures, restrictions and requirements.
- Agree to refrain from the consumption of grapefruit or grapefruit juice beginning 1 week prior to administration of the initial administration fedovapagon, moxifloxacin or placebo, throughout the trial.
- Agree to refrain from the consumption of alcohol and/or methylxanthines e.g., caffeine (coffee, tea and cola) beginning 96 hours prior to administration of the initial administration of fedovapagon, moxifloxacin or placebo, throughout the trial.
- Current non-smokers who have not used any nicotine-containing products (chewed or smoked) or replacement products including electronic cigarettes in the 45 days prior to screening.
- Woman of child-bearing potential must be using effective methods (failure rate <1%) of birth control at least 4 weeks prior to Screening until 4 weeks after the administration of fedovapagon, moxifloxacin or placebo.
- Male subjects should be willing to use a condom with spermicide during sexual activity with female partners of child-bearing potential and must not donate sperm. Female sexual partners of male subjects should be willing to avoid pregnancy.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Single Centre, Randomized, Double Blind (Except For Moxifloxacin), Placebo And Active Controlled, Four Way Cross Over Study Investigating The Effect Of Single Therapeutic And Supra Therapeutic Doses Of Fedovapagon On The QT/QTC Interval In Healthy Volunteers Using Oral Moxifloxacin To Confirm Assay Sensitivity
The purpose of this study is to assess the electrocardiogram (ECG) effects of fedovapagon dose administration relative to placebo in healthy adult male and female subjects.
Read the detailed description
Regulatory guidance (ICH E14) has emphasized the need to obtain clear robust data on the effect of new chemical entities on ECG parameters with focus on cardiac repolarization as measured by the QTc duration. Though many Phase 1, 2 and 3 trials may be conducted they usually have insufficient sample size, infrequent sampling of ECG data, or the use of inadequate controls to overcome the high rate of spontaneous change in QTc duration. This has resulted in regulatory guidance recommending a dedicated or thorough trial to define the ECG effects of new drugs.
This study will be conducted in healthy volunteers to eliminate variables known to have an effect on ECG parameters (concomitant drugs, diseases, etc.). A supra-therapeutic dose of fedovapagon is required to mimic the exposure in healthy volunteers that may occur in the target population under the worst of circumstances (e.g., concomitant use of CYP3A4 inhibitor, concomitant liver disease, presence of heart disease, taking more than the clinical dose prescribed, etc.) and to allow for PK to QTc modeling to assess the effect of drug concentration on cardiac repolarization.
A cross-over trial is the preferred design as subjects act as their own controls and since there is no accumulation of any clinical relevance and the plasma concentration of parent dissipates before 24 hours, a single dose trial will be employed. During the course of the study each subject will be administered fedovapagon at both a clinical and supra-therapeutic dose, placebo and moxifloxacin (as a positive control).
The sample size is driven by the need to do a time-matched statistical analysis on the primary endpoint as per ICH E14 guidance.
- Conditions
- Healthy
- Being tested
- Fedovapagon, Moxifloxacin, Placebo (for fedovapagon)
- Keywords
- VA106483, fedovapagon, males, females, moxifloxacin, TQT, QT/QTC, ECG, Nocturia
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FedovapagonDrug
MoxifloxacinDrug
Placebo (for fedovapagon)Drug
| Study group | Role | What they receive |
|---|---|---|
| Placebo matched to fedovapagon | Experimental | One dose of placebo (matched to fedovapagon) Receives: Drug: Placebo (for fedovapagon) |
| Fedovapagon 2 mg | Experimental | One dose of 2 mg fedovapagon Receives: Drug: Fedovapagon |
| Fedovapagon 20 mg | Experimental | One dose of 20 mg fedovapagon Receives: Drug: Fedovapagon |
| Moxifloxacin 400 mg (open label) | Experimental | One dose of moxifloxacin 400 mg (open label) Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-matched change from baseline in QTc, placebo-adjusted and corrected for heart rate
Measured: 0-48 hours
Secondary outcomes (11)
Heart rate
Measured: 0-48 hours
PR interval
Measured: 0-48 hours
QRS interval
Measured: 0-48 hours
Uncorrected QT interval
Measured: 0-48 hours
ECG morphology especially on repolarization
Measured: 0-48 hours
Correlation between the QTc change from baseline and plasma concentrations of fedovapagon
Measured: 0-48 hours
Number and type of adverse events
Measured: 0-48 hours
The observed maximum plasma concentration (Cmax)
Measured: 0-48 hours
Time to reach maximum plasma concentration (tmax)
Measured: 0-48 hours
Apparent terminal half-life (t½)
Measured: 0-48 hours
Area under the plasma concentration-time curve (AUC0-t), (AUC0-24h) and (AUC0-∞)
Measured: 0-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantia Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Georg Golor, PD Dr med, Principal investigator, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537288
- Sponsor's protocol ID
- 483-012
- Status last verified
- Jan 2016
- First submitted
- 5 Aug 2015
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Single Centre, Randomized, Double Blind (Except For Moxifloxacin), Placebo And Active Controlled, Four Way Cross Over Study Investigating The Effect Of Single Therapeutic And Supra Therapeutic Doses Of Fedovapagon On The QT/QTC Interval In Healthy Volunteers Using Oral Moxifloxacin To Confirm Assay Sensitivity
- ClinicalTrials.gov ID
- NCT02537288
- Acronym / sponsor ID
- 483-012
- Conditions
- Healthy
- Keywords
- VA106483, fedovapagon, males, females, moxifloxacin, TQT, QT/QTC, ECG
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Vantia LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Sep 2015 (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 this study is to assess the electrocardiogram (ECG) effects of fedovapagon dose administration relative to placebo in healthy adult male and female subjects.
Detailed description
Regulatory guidance (ICH E14) has emphasized the need to obtain clear robust data on the effect of new chemical entities on ECG parameters with focus on cardiac repolarization as measured by the QTc duration. Though many Phase 1, 2 and 3 trials may be conducted they usually have insufficient sample size, infrequent sampling of ECG data, or the use of inadequate controls to overcome the high rate of spontaneous change in QTc duration. This has resulted in regulatory guidance recommending a dedicated or thorough trial to define the ECG effects of new drugs.
This study will be conducted in healthy volunteers to eliminate variables known to have an effect on ECG parameters (concomitant drugs, diseases, etc.). A supra-therapeutic dose of fedovapagon is required to mimic the exposure in healthy volunteers that may occur in the target population under the worst of circumstances (e.g., concomitant use of CYP3A4 inhibitor, concomitant liver disease, presence of heart disease, taking more than the clinical dose prescribed, etc.) and to allow for PK to QTc modeling to assess the effect of drug concentration on cardiac repolarization.
A cross-over trial is the preferred design as subjects act as their own controls and since there is no accumulation of any clinical relevance and the plasma concentration of parent dissipates before 24 hours, a single dose trial will be employed. During the course of the study each subject will be administered fedovapagon at both a clinical and supra-therapeutic dose, placebo and moxifloxacin (as a positive control).
The sample size is driven by the need to do a time-matched statistical analysis on the primary endpoint as per ICH E14 guidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo matched to fedovapagon | Experimental | Drug: Placebo (for fedovapagon)One dose of placebo (matched to fedovapagon) |
| Fedovapagon 2 mg | Experimental | Drug: FedovapagonOne dose of 2 mg fedovapagon |
| Fedovapagon 20 mg | Experimental | Drug: FedovapagonOne dose of 20 mg fedovapagon |
| Moxifloxacin 400 mg (open label) | Experimental | Drug: MoxifloxacinOne dose of moxifloxacin 400 mg (open label) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Provide signed and dated informed consent before any study-specific procedures are conducted.
- Healthy males and females 18 to 55 years of age (inclusive).
- No clinically significant abnormal physical findings.
- No clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or admission.
- Have a body mass index (BMI) ≥18.0 to ≤29.9 kg/m2 (weight: ≥50 kg and ≤100 kg) at the Screening visit.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Fedovapagon | Drug | Fedovapagon 2 mg, Fedovapagon 20 mg |
| Moxifloxacin | Drug | Moxifloxacin 400 mg (open label) |
| Placebo (for fedovapagon) | Drug | Placebo matched to fedovapagon |
Primary outcome
Time-matched change from baseline in QTc, placebo-adjusted and corrected for heart rate
Time frame: 0-48 hours
11 secondary outcomes
Heart rate
Time frame: 0-48 hours
PR interval
Time frame: 0-48 hours
QRS interval
Time frame: 0-48 hours
Uncorrected QT interval
Time frame: 0-48 hours
ECG morphology especially on repolarization
Time frame: 0-48 hours
Correlation between the QTc change from baseline and plasma concentrations of fedovapagon
Time frame: 0-48 hours
Number and type of adverse events
Time frame: 0-48 hours
The observed maximum plasma concentration (Cmax)
Time frame: 0-48 hours
Time to reach maximum plasma concentration (tmax)
Time frame: 0-48 hours
Apparent terminal half-life (t½)
Time frame: 0-48 hours
Area under the plasma concentration-time curve (AUC0-t), (AUC0-24h) and (AUC0-∞)
Time frame: 0-48 hours
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 6 Jan 2016.
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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.
Georg Golor, PD Dr med principal investigator
Parexel
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 Fedovapagon and Moxifloxacin in people with Healthy, run by Vantia Ltd at 1 site in Germany.
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 14 inclusion and 0 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 6 Jan 2016. 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 Germany. 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?
Time-matched change from baseline in QTc, placebo-adjusted and corrected for heart rate (time frame: 0-48 hours). 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 6 Jan 2016.