Healthy VolunteersPhase 1NCT00987038
A Midazolam Drug Interaction Study With PF-04171327
A Phase 1 study testing PF-04171327 25 mg and Midazolam 2 mg in people with Healthy Volunteers, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of multiple doses of PF-04171327 on the blood levels (pharmacokinetics) of midazolam Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- PF-04171327 25 mg and Midazolam 2 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2009
- 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
- Healthy males and/or females (non-childbearing potential) volunteers.
- Cortisol level within normal reference range of the laboratory.
Who cannot join
- History of intolerance or significant adverse effect with glucocorticoid (steroid) therapy.
- History or current positive results for HIV, Hepatitis B or C or active TB or currently undergoing treatment for TB.
- Known history of hypersensitivity, allergy severe drug reaction or unable to tolerate midazolam or other benzodiazepines.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: A Phase 1, Open Label, Multiple Dose Study Of The Effect Of PF-04171327 On Midazolam Pharmacokinetics In Healthy Volunteers
The purpose of this study is to investigate the effects of multiple doses of PF-04171327 on the blood levels (pharmacokinetics) of midazolam
- Conditions
- Healthy Volunteers
- Being tested
- PF-04171327 25 mg, Midazolam 2 mg
- Keywords
- drug interaction CYP3A4 glucocorticoids midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04171327 25 mgDrug
One 25 mg tablet administered once a day for 15 days
Midazolam 2 mgDrug
Midazolam oral syrup 2mg dose administered once on Day 1 and once on Day 15
| Study group | Role | What they receive |
|---|---|---|
| PF-04171327 and Midazolam | Other | Not described Receives: Drug: PF-04171327 25 mg; Drug: Midazolam 2 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCinf of midazolam
Measured: 17 days
Secondary outcomes (2)
AUClast, Cmax, Tmax, t1/2
Measured: 17 days
Vital Signs, Clinical Laboratory tests and Adverse Events
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987038
- Sponsor's protocol ID
- A9391007
- Status last verified
- Dec 2009
- First submitted
- 29 Sep 2009
- Last updated
- 8 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Ripp SL, Mukherjee A, Eng H, Stock T, Fleishaker D, Checchio T, Tammara B. In Vitro and In Vivo Investigation of Potential for Complex CYP3A Interaction for PF-00251802 (Dagrocorat), a Novel Dissociated Agonist of the Glucocorticoid Receptor. Clin Pharmacol Drug Dev. 2018 Mar;7(3):244-255. doi: 10.1002/cpdd.411. Epub 2017 Nov 7.
PubMed 29112329
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Multiple Dose Study Of The Effect Of PF-04171327 On Midazolam Pharmacokinetics In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00987038
- Acronym / sponsor ID
- A9391007
- Conditions
- Healthy Volunteers
- Keywords
- drug interaction CYP3A4 glucocorticoids midazolam
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 30 Sep 2009 (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 effects of multiple doses of PF-04171327 on the blood levels (pharmacokinetics) of midazolam
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PF-04171327 and Midazolam | Other | Drug: PF-04171327 25 mg, Drug: Midazolam 2 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males and/or females (non-childbearing potential) volunteers.
- Cortisol level within normal reference range of the laboratory.
Key exclusion criteria (3 listed)
- History of intolerance or significant adverse effect with glucocorticoid (steroid) therapy.
- History or current positive results for HIV, Hepatitis B or C or active TB or currently undergoing treatment for TB.
- Known history of hypersensitivity, allergy severe drug reaction or unable to tolerate midazolam or other benzodiazepines.
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 |
|---|---|---|
| PF-04171327 25 mgOne 25 mg tablet administered once a day for 15 days | Drug | PF-04171327 and Midazolam |
| Midazolam 2 mgMidazolam oral syrup 2mg dose administered once on Day 1 and once on Day 15 | Drug | PF-04171327 and Midazolam |
Primary outcome
AUCinf of midazolam
Time frame: 17 days
2 secondary outcomes
AUClast, Cmax, Tmax, t1/2
Time frame: 17 days
Vital Signs, Clinical Laboratory tests and Adverse Events
Time frame: 28 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 8 Dec 2009.
- Derived from this study: PubMed 29112329Ripp SL, Mukherjee A, Eng H, Stock T, Fleishaker D, Checchio T, Tammara B. In Vitro and In Vivo Investigation of Potential for Complex CYP3A Interaction for PF-00251802 (Dagrocorat), a Novel Dissociated Agonist of the Glucocorticoid Receptor. Clin Pharmacol Drug Dev. 2018 Mar;7(3):244-255. doi: 10.1002/cpdd.411. Epub 2017 Nov 7.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
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 PF-04171327 25 mg and Midazolam 2 mg in people with Healthy Volunteers, run by Pfizer 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 3 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 8 Dec 2009. 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?
AUCinf of midazolam (time frame: 17 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00987038, which also lists 1 linked publication.
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 8 Dec 2009.