Healthy VolunteerPhase 1NCT03916406
THE EFFECT OF MULTIPLE DOSES OF PF-06835919 ON THE PHARMACOKINETICS OF A SINGLE ORAL MIDAZOLAM DOSE IN HEALTHY PARTICIPANTS
A Phase 1 study testing PF 06835919 and Midazolam in people with Healthy Volunteer, run by Pfizer at 1 site in Belgium.
Trial summary
This is a Phase 1, randomized, open label, 2 way crossover drug drug interaction (DDI) study which will evaluate the impact of PF 06835919 on midazolam pharmacokinetics in healthy participants. Participants will be randomized to 1 of 2 treatment sequences as described below. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- PF 06835919 and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Apr 2019to 25 Jun 2019
- 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
- Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiovascular tests.
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed
- Participants, who according to the product label for midazolam, would be at increased risk if dosed with midazolam (ie, including but not limited to participants with history of myasthenia gravis, chronic obstructive pulmonary disease (COPD), pulmonary insufficiency, glaucoma, concomitant central nervous system (CNS) depressants).
- History of hypersensitivity to midazolam or any other benzodiazepine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A PHASE 1, RANDOMIZED, OPEN LABEL, 2-WAY CROSSOVER STUDY TO EVALUATE THE EFFECT OF REPEATED DOSING OF PF-06835919 ON THE PHARMACOKINETICS OF A SINGLE ORAL DOSE OF MIDAZOLAM IN HEALTHY PARTICIPANTS
This is a Phase 1, randomized, open label, 2 way crossover drug drug interaction (DDI) study which will evaluate the impact of PF 06835919 on midazolam pharmacokinetics in healthy participants. Participants will be randomized to 1 of 2 treatment sequences as described below. A total of approximately 10 healthy male and/or female participants will be enrolled in this study so that approximately 5 participants will be enrolled into each treatment sequence. In this crossover study, 2 treatments are being assessed.
- Conditions
- Healthy Volunteer
- Being tested
- PF 06835919, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF 06835919Drug
300 mg
MidazolamDrug
7.5 mg
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | midazolam alone followed by combination of PF 06835919 and midazolam Receives: Drug: PF 06835919; Drug: Midazolam |
| Sequence 2 | Experimental | PF 06835919 in combination with midazolam followed by midazolam alone Receives: Drug: PF 06835919; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCinf of midazolam following a single oral dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
Measured: Baseline up to 51 days
Secondary outcomes (3)
AUClast of midazolam following a single oral dose.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Measured: Baseline up to 51 days
Cmax of midazolam following a single oral dose.
Maximum Observed Plasma Concentration (Cmax)
Measured: Baseline up to 51 days
Incidence of Adverse Events in participants
Measured: Screening up to 79 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start18 Apr 2019
- Primary completion25 Jun 2019
- Study completion25 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916406
- Sponsor's protocol ID
- C1061016
- Other IDs
- 2019-000929-42, 2019
- Status last verified
- Jul 2019
- First submitted
- 12 Apr 2019
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, RANDOMIZED, OPEN LABEL, 2-WAY CROSSOVER STUDY TO EVALUATE THE EFFECT OF REPEATED DOSING OF PF-06835919 ON THE PHARMACOKINETICS OF A SINGLE ORAL DOSE OF MIDAZOLAM IN HEALTHY PARTICIPANTS
- ClinicalTrials.gov ID
- NCT03916406
- Acronym / sponsor ID
- C1061016
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 25 Jun 2019 (actual)
- First posted
- 16 Apr 2019 (actual)
- 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.
This is a Phase 1, randomized, open label, 2 way crossover drug drug interaction (DDI) study which will evaluate the impact of PF 06835919 on midazolam pharmacokinetics in healthy participants. Participants will be randomized to 1 of 2 treatment sequences as described below. A total of approximately 10 healthy male and/or female participants will be enrolled in this study so that approximately 5 participants will be enrolled into each treatment sequence. In this crossover study, 2 treatments are being assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: PF 06835919, Drug: Midazolammidazolam alone followed by combination of PF 06835919 and midazolam |
| Sequence 2 | Experimental | Drug: PF 06835919, Drug: MidazolamPF 06835919 in combination with midazolam followed by midazolam alone |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiovascular tests.
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
Key exclusion criteria (4 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed
- Participants, who according to the product label for midazolam, would be at increased risk if dosed with midazolam (ie, including but not limited to participants with history of myasthenia gravis, chronic obstructive pulmonary disease (COPD), pulmonary insufficiency, glaucoma, concomitant central nervous system (CNS) depressants).
- History of hypersensitivity to midazolam or any other benzodiazepine
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 06835919300 mg | Drug | Sequence 1, Sequence 2 |
| Midazolam7.5 mg | Drug | Sequence 1, Sequence 2 |
Primary outcome
AUCinf of midazolam following a single oral dose
Time frame: Baseline up to 51 days
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
3 secondary outcomes
AUClast of midazolam following a single oral dose.
Time frame: Baseline up to 51 days
Cmax of midazolam following a single oral dose.
Time frame: Baseline up to 51 days
Incidence of Adverse Events in participants
Time frame: Screening up to 79 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 16 Jul 2019.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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 06835919 and Midazolam in people with Healthy Volunteer, run by Pfizer at 1 site in Belgium.
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 4 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 16 Jul 2019. 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 Belgium. 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 following a single oral dose (time frame: Baseline up to 51 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 16 Jul 2019.