Drug Interaction PotentiationPhase 1NCT01477411
A Drug-Drug Interaction Study of Digoxin and PA21
A Phase 1 study testing PA21 and Digoxin in people with Drug Interaction Potentiation, run by Vifor Pharma at 1 site in United States.
Trial summary
The purpose of this study is to determine if Digoxin 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
- Drug Interaction Potentiation
- What is being tested?
- PA21 and Digoxin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jan 2012
- 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 Digoxin in Healthy Male and Female Adults
The purpose of this study is to determine if Digoxin is affected by PA21.
- Conditions
- Drug Interaction Potentiation
- Being tested
- PA21, Digoxin
- Keywords
- Drug-drug interaction, Pharmacokinetics, PA21
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA21Drug
The maximum dose of PA21 will be 15.0 g/day.
DigoxinDrug
The maximum dosage of Digoxin will be 0.5 mg/day
| Study group | Role | What they receive |
|---|---|---|
| PA21 and Digoxin with food | Experimental | The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Digoxin will be 0.5 mg/day Receives: Drug: PA21; Drug: Digoxin |
| No PA21; Digoxin with food | Experimental | The maximum dosage of Digoxin will be 0.5 mg/day Receives: Drug: Digoxin |
| PA21 with food and Digoxin 2hrs later | Experimental | The maximum dose of PA21 will be 15 g/day. The maximum dose of Digoxin will be 0.5 mg/day Receives: Drug: PA21; Drug: Digoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve from time zero to 24 hours (AUC0-24)
Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours
Measured: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post digoxin dose on Days 0, 11, 22
Area Under the Curve from time zero to infinite (AUC0-infinity)
Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time
Measured: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post Digoxin dose on Days 0, 11, 22
Maximum observed plasma concentration (Cmax)
Measured: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post Digoxin dose on days 0, 11, 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Interaction PotentiationStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- Vifor Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Winkle, MD, Principal investigator, ACRI - Phase 1 (Advanced Clinical Research Institute)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477411
- Sponsor's protocol ID
- PA-DDI-004
- Status last verified
- Jan 2012
- First submitted
- 16 Nov 2011
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. 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 Digoxin in Healthy Male and Female Adults
- ClinicalTrials.gov ID
- NCT01477411
- Acronym / sponsor ID
- PA-DDI-004
- Conditions
- Drug Interaction Potentiation
- Keywords
- Drug-drug interaction, Pharmacokinetics, PA21
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Vifor PharmaIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 22 Nov 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 Digoxin 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 Digoxin with food | Experimental | Drug: PA21, Drug: DigoxinThe maximum dose of PA21 will be 15.0 g/day. The maximum dose of Digoxin will be 0.5 mg/day |
| No PA21; Digoxin with food | Experimental | Drug: DigoxinThe maximum dosage of Digoxin will be 0.5 mg/day |
| PA21 with food and Digoxin 2hrs later | Experimental | Drug: PA21, Drug: DigoxinThe maximum dose of PA21 will be 15 g/day. The maximum dose of Digoxin will be 0.5 mg/day |
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 |
|---|---|---|
| PA21The maximum dose of PA21 will be 15.0 g/day. | Drug | PA21 and Digoxin with food, PA21 with food and Digoxin 2hrs later |
| DigoxinThe maximum dosage of Digoxin will be 0.5 mg/day | Drug | No PA21; Digoxin with food, PA21 and Digoxin with food, PA21 with food and Digoxin 2hrs later |
Primary outcome
Area Under the Curve from time zero to 24 hours (AUC0-24)
Time frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post digoxin dose on Days 0, 11, 22
Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours
Area Under the Curve from time zero to infinite (AUC0-infinity)
Time frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post Digoxin dose on Days 0, 11, 22
Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time
Maximum observed plasma concentration (Cmax)
Time frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post Digoxin dose on days 0, 11, 22
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 18 Jan 2012.
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 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 Digoxin in people with Drug Interaction Potentiation, 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 18 Jan 2012. 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?
Area Under the Curve from time zero to 24 hours (AUC0-24) (time frame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours post digoxin dose on Days 0, 11, 22). 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 18 Jan 2012.