NocturiaPhase 1NCT02440841
Study in Healthy Male Subjects to Evaluate the Effect of Itraconazole and Rifampicin on the PK of Fedovapagon
A Phase 1 study testing fedovapagon, Itraconazole and rifampicin in people with Nocturia, run by Vantia Ltd at 1 site in Germany.
Trial summary
The purpose of this study is to investigate the potential for co-administration of strong inhibitors or inducers of CYP3A4 to alter the pharmacokinetics of fedovapagon. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nocturia
- What is being tested?
- fedovapagon, Itraconazole and rifampicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteGermany
- Study dates
- May 2015to Jul 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males aged 18 to 45
- Have a body mass index between 18 and 29.9 kg/m2 (weight: ≥50 kg and ≤100 kg)
- No clinically significant medical history
- Ability to comply with the requirements of the study
- Provide written informed consent
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) should be below or equal to upper level of normal (ULN). Otherwise liver enzymes should show no clinical significant abnormalities. Total bilirubin should not exceed 1.5 x ULN. Liver enzymes will be re-tested only once before randomization if required.
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- Be judged by the Investigator to be in good health based on medical history (in particular, no congestive heart failure, ischemic heart disease, valvular heart disease, significant pulmonary disease, renal failure, edematous disorder, liver disease, gastric disorders, porphyria, diabetes mellitus or hereditary disorders of carbohydrate metabolism), physical examination, vital sign measurements and laboratory safety tests
- Agree to refrain from the consumption of grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, brussels sprouts, mustard) and charbroiled meats containing products beginning 1 week prior to administration of the initial administration of trial drug, throughout the trial
- Use of any prescribed medication or St John's Wort within 14 days (or 5 half-lives if this is longer) or over-the-counter medication (except paracetamol) within 1 week of dosing. Specific medication not to be taken within 2 weeks of (before or after) administration of itraconazole is described in the Summary of Product Characteristic for Sempera®
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Center, Open-Label, Single-Sequence, Within-Subject Study In Two Cohorts Of Healthy Male Subjects Comparing Single-Dose Pharmacokinetics Of Fedovapagon Alone And In Combination With A CYP3A4 Inhibitor, Itraconazole, Or A CYP3A4 Inducer, Rifampicin
The purpose of this study is to investigate the potential for co-administration of strong inhibitors or inducers of CYP3A4 to alter the pharmacokinetics of fedovapagon.
Read the detailed description
Fedovapagon is a vasopressin V2 receptor agonist in development for the treatment of nocturia. Agonism of the V2 receptor, located in the collecting ducts of the kidney, leads to translocation of aquaporin channels and increased re absorption of water and anti-diuresis.
A number of drugs that are commonly co-prescribed in the population who may present for treatment of nocturia are inhibitors of CYP3A4, including diltiazem, verapamil, erythromycin and clarithromycin and may therefore impact the plasma levels of fedovapagon if co administered.
Conversely, concomitant intake of drugs that are potent CYP3A4 inducers may lead to lower than anticipated plasma concentrations of fedovapagon thus reducing the efficacy of fedovapagon. It is therefore important to assess the effect of CYP3A4 induction on the pharmacokinetic (PK) parameters of fedovapagon.
The study design uses itraconazole as a potent inhibitor of CYP3A4 and, in a separate cohort of subjects, rifampicin as a potent CYP3A4 inducer at doses intended to maximize the potential to demonstrate an interaction.
- Conditions
- Nocturia
- Being tested
- fedovapagon, Itraconazole, rifampicin
- Keywords
- VA106483, fedovapagon, drug-drug interaction, DDI, males, rifampicin, rifampin, itraconazole, CYP3A4, pharmacokinetics, PK
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fedovapagonDrug
ItraconazoleDrug
rifampicinDrug
| Study group | Role | What they receive |
|---|---|---|
| fedovapagon and itraconazole | Experimental | Two daily doses of fedovapagon and once daily doses of itraconazole Receives: Drug: fedovapagon; Drug: Itraconazole |
| fedovapagon and rifampicin | Experimental | Two daily doses of fedovapagon and once daily doses of rifampicin Receives: Drug: fedovapagon; Drug: rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma fedovapagon concentration in presence and absence of co-administered itraconazole or rifampicin
Measured: 10-12 days
Secondary outcomes (6)
Maximum observed plasma concentration (Cmax)
Measured: 10-12 days
Area under the plasma concentration curve versus time curve with extrapolation to infinity (AUC(0-infinity))
Measured: 10-12 days
Number and type of adverse events
Measured: 12-14 days
Change from baseline in 12-lead ECG
Measured: 12-14 days
Change from baseline in vital signs and physical examination
Measured: 12-14 days
Change from baseline in laboratory assessments
Measured: 12-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NocturiaStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantia Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tshibuabua Kabasela, Study director, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440841
- Sponsor's protocol ID
- 483-010
- Status last verified
- Jul 2015
- First submitted
- 7 May 2015
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center, Open-Label, Single-Sequence, Within-Subject Study In Two Cohorts Of Healthy Male Subjects Comparing Single-Dose Pharmacokinetics Of Fedovapagon Alone And In Combination With A CYP3A4 Inhibitor, Itraconazole, Or A CYP3A4 Inducer, Rifampicin
- ClinicalTrials.gov ID
- NCT02440841
- Acronym / sponsor ID
- 483-010
- Conditions
- Nocturia
- Keywords
- VA106483, fedovapagon, drug-drug interaction, DDI, males, rifampicin, rifampin, itraconazole
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Vantia LtdIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 12 May 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 investigate the potential for co-administration of strong inhibitors or inducers of CYP3A4 to alter the pharmacokinetics of fedovapagon.
Detailed description
Fedovapagon is a vasopressin V2 receptor agonist in development for the treatment of nocturia. Agonism of the V2 receptor, located in the collecting ducts of the kidney, leads to translocation of aquaporin channels and increased re absorption of water and anti-diuresis.
A number of drugs that are commonly co-prescribed in the population who may present for treatment of nocturia are inhibitors of CYP3A4, including diltiazem, verapamil, erythromycin and clarithromycin and may therefore impact the plasma levels of fedovapagon if co administered.
Conversely, concomitant intake of drugs that are potent CYP3A4 inducers may lead to lower than anticipated plasma concentrations of fedovapagon thus reducing the efficacy of fedovapagon. It is therefore important to assess the effect of CYP3A4 induction on the pharmacokinetic (PK) parameters of fedovapagon.
The study design uses itraconazole as a potent inhibitor of CYP3A4 and, in a separate cohort of subjects, rifampicin as a potent CYP3A4 inducer at doses intended to maximize the potential to demonstrate an interaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fedovapagon and itraconazole | Experimental | Drug: fedovapagon, Drug: ItraconazoleTwo daily doses of fedovapagon and once daily doses of itraconazole |
| fedovapagon and rifampicin | Experimental | Drug: fedovapagon, Drug: rifampicinTwo daily doses of fedovapagon and once daily doses of rifampicin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy males aged 18 to 45
- Have a body mass index between 18 and 29.9 kg/m2 (weight: ≥50 kg and ≤100 kg)
- No clinically significant medical history
- Ability to comply with the requirements of the study
- Provide written informed consent
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 and itraconazole, fedovapagon and rifampicin |
| Itraconazole | Drug | fedovapagon and itraconazole |
| rifampicin | Drug | fedovapagon and rifampicin |
Primary outcome
Plasma fedovapagon concentration in presence and absence of co-administered itraconazole or rifampicin
Time frame: 10-12 days
6 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: 10-12 days
Area under the plasma concentration curve versus time curve with extrapolation to infinity (AUC(0-infinity))
Time frame: 10-12 days
Number and type of adverse events
Time frame: 12-14 days
Change from baseline in 12-lead ECG
Time frame: 12-14 days
Change from baseline in vital signs and physical examination
Time frame: 12-14 days
Change from baseline in laboratory assessments
Time frame: 12-14 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 30 Jul 2015.
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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.
Tshibuabua Kabasela study director
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, Itraconazole and rifampicin in people with Nocturia, 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 9 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 30 Jul 2015. 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?
Plasma fedovapagon concentration in presence and absence of co-administered itraconazole or rifampicin (time frame: 10-12 days). 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 30 Jul 2015.