HealthyPhase 1NCT01452906
A Drug-Drug Interaction Study of Omeprazole and PA21
A Phase 1 study testing PA21 and Omeprazole with food, No PA21; Omeprazole with food and PA21 with food, Omeprazole 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 Omeprazole 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 Omeprazole with food, No PA21; Omeprazole with food and PA21 with food, Omeprazole 2hrs later
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Dec 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 Omeprazole in Healthy Male and Female Adults
The purpose of this study is to determine if Omeprazole is affected by PA21.
- Conditions
- Healthy
- Being tested
- PA21 and Omeprazole with food, No PA21; Omeprazole with food, PA21 with food, Omeprazole 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 Omeprazole with foodDrug
The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Omeprazole will be 40 mg/day
No PA21; Omeprazole with foodDrug
The maximum dosage of Omeprazole will be 40 mg/day
PA21 with food, Omeprazole 2hrs laterDrug
The maximum dose of PA21 will be 15 g/day. The maximum dose of Omeprazole will be 40 mg/day
| Study group | Role | What they receive |
|---|---|---|
| PA21 and Omeprazole with food | Experimental | Not described Receives: Drug: PA21 and Omeprazole with food |
| No PA21; Omeprazole with food | Experimental | Not described Receives: Drug: No PA21; Omeprazole with food |
| PA21 with food, Omeprazole 2 hrs later | Experimental | Not described Receives: Drug: PA21 with food, Omeprazole 2hrs later |
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, 3.5, 4, 5, 6, 8, 12, 24 hours post omeprazole 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, 3.5, 4, 5, 6, 8, 12, 24, 48 hours post omeprazole dose on days 0, 11, 22
Maximum observed plasma concentration (Cmax)
Measured: pre-dose, 0.25, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours post omeprazole 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 posted17 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionDec 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
- 45 participants (actual)
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
- NCT01452906
- Sponsor's protocol ID
- PA-DDI-003
- Status last verified
- Dec 2011
- First submitted
- 22 Sep 2011
- Last updated
- 12 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 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 Omeprazole in Healthy Male and Female Adults
- ClinicalTrials.gov ID
- NCT01452906
- Acronym / sponsor ID
- PA-DDI-003
- Conditions
- Healthy
- Keywords
- Drug-drug interaction, Pharmacokinetics, PA21, Drug Interaction Potentiation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Vifor PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Oct 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 Omeprazole 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 Omeprazole with food | Experimental | Drug: PA21 and Omeprazole with food |
| No PA21; Omeprazole with food | Experimental | Drug: No PA21; Omeprazole with food |
| PA21 with food, Omeprazole 2 hrs later | Experimental | Drug: PA21 with food, Omeprazole 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 Omeprazole with foodThe maximum dose of PA21 will be 15.0 g/day. The maximum dose of Omeprazole will be 40 mg/day | Drug | PA21 and Omeprazole with food |
| No PA21; Omeprazole with foodThe maximum dosage of Omeprazole will be 40 mg/day | Drug | No PA21; Omeprazole with food |
| PA21 with food, Omeprazole 2hrs laterThe maximum dose of PA21 will be 15 g/day. The maximum dose of Omeprazole will be 40 mg/day | Drug | PA21 with food, Omeprazole 2 hrs 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, 3.5, 4, 5, 6, 8, 12, 24 hours post omeprazole 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, 3.5, 4, 5, 6, 8, 12, 24, 48 hours post omeprazole 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, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours post omeprazole 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 12 Dec 2011.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
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
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 Omeprazole with food, No PA21; Omeprazole with food and PA21 with food, Omeprazole 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 12 Dec 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?
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, 3.5, 4, 5, 6, 8, 12, 24 hours post omeprazole 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 12 Dec 2011.