HealthyPhase 1NCT01438359
A Drug-Drug Interaction Study of Furosemide and PA21
A Phase 1 study testing PA21 and Furosemide with food, No PA21; Furosemide with food and PA21 with food and Furosemide 2hrs later in people with Healthy, run by Vifor Pharma at 1 site in United States.
Trial summary
The purpose of this study is to determine if Furosemide is affected by PA21. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PA21 and Furosemide with food, No PA21; Furosemide with food and PA21 with food and Furosemide 2hrs later
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Sep 2011
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
- Written informed consent
Who cannot join
- No significant medical conditions
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Open-label, Three-period Study of the Pharmacokinetic Effect of PA21 on Furosemide in Healthy Male and Female Adults
The purpose of this study is to determine if Furosemide is affected by PA21.
- Conditions
- Healthy
- Being tested
- PA21 and Furosemide with food, No PA21; Furosemide with food, PA21 with food and Furosemide 2hrs later
- Keywords
- Drug-drug interaction, Pharmacokinetics, PA21, Drug Interaction Potentiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA21 and Furosemide with foodDrug
The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Furosemide will be 40 mg/day
No PA21; Furosemide with foodDrug
The maximum dosage of Furosemide will be 40 mg/day
PA21 with food and Furosemide 2hrs laterDrug
The maximum dose of PA21 will be 15 g/day. The maximum dose of Furosemide will be 40 mg/day
| Study group | Role | What they receive |
|---|---|---|
| PA21 and Furosemide with food | Experimental | Not described Receives: Drug: PA21 and Furosemide with food |
| No PA21; Furosemide with food | Experimental | Not described Receives: Drug: No PA21; Furosemide with food |
| PA21 with food and Furosemide 2hrs later | Experimental | Not described Receives: Drug: PA21 with food and Furosemide 2hrs later |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of PA21 on Furosemide
To assess the effect, if any, of PA21 on Furosemide exposure(AUC0-24; AUC0-infinity; Cmax; Tmax and t1/2).
Measured: PK assessment on Day 0, 11, and 22: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hrs post furosemide dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study startJul 2011
- Primary completionSep 2011
- Study completionSep 2011
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vifor Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter J Winkle, MD, Principal investigator, ACRI - Phase 1 (Advanced Clinical Research Institute)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438359
- Sponsor's protocol ID
- PA-DDI-002
- Status last verified
- Sep 2011
- First submitted
- 16 Sep 2011
- Last updated
- 30 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Open-label, Three-period Study of the Pharmacokinetic Effect of PA21 on Furosemide in Healthy Male and Female Adults
- ClinicalTrials.gov ID
- NCT01438359
- Acronym / sponsor ID
- PA-DDI-002
- Conditions
- Healthy
- Keywords
- Drug-drug interaction, Pharmacokinetics, PA21, Drug Interaction Potentiation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Vifor PharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 22 Sep 2011 (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 determine if Furosemide is affected by PA21.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PA21 and Furosemide with food | Experimental | Drug: PA21 and Furosemide with food |
| No PA21; Furosemide with food | Experimental | Drug: No PA21; Furosemide with food |
| PA21 with food and Furosemide 2hrs later | Experimental | Drug: PA21 with food and Furosemide 2hrs later |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteers
- Written informed consent
Key exclusion criteria (2 listed)
- No significant medical conditions
- Pregnancy
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 |
|---|---|---|
| PA21 and Furosemide with foodThe maximum dose of PA21 will be 15.0 g/day. The maximum dose of Furosemide will be 40 mg/day | Drug | PA21 and Furosemide with food |
| No PA21; Furosemide with foodThe maximum dosage of Furosemide will be 40 mg/day | Drug | No PA21; Furosemide with food |
| PA21 with food and Furosemide 2hrs laterThe maximum dose of PA21 will be 15 g/day. The maximum dose of Furosemide will be 40 mg/day | Drug | PA21 with food and Furosemide 2hrs later |
Primary outcome
Effect of PA21 on Furosemide
Time frame: PK assessment on Day 0, 11, and 22: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hrs post furosemide dose
To assess the effect, if any, of PA21 on Furosemide exposure(AUC0-24; AUC0-infinity; Cmax; Tmax and t1/2).
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 Sep 2011.
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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.
Peter J Winkle, MD principal investigator
ACRI - Phase 1 (Advanced Clinical Research Institute)
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 PA21 and Furosemide with food, No PA21; Furosemide with food and PA21 with food and Furosemide 2hrs later in people with Healthy, run by Vifor Pharma at 1 site in United States.
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 2 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 Sep 2011. 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 States. 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?
Effect of PA21 on Furosemide (time frame: PK assessment on Day 0, 11, and 22: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hrs post furosemide dose). 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 Sep 2011.