HealthyPhase 1NCT03656952
A Study to Evaluate the PF-06700841 Effect on QTc Interval in Healthy Volunteers
A Phase 1 study testing PF-06700841 and moxifloxacin in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
A phase 1, 6-sequence, 3-period, subject- and investigator blinded and sponsor-open, crossover study in healthy volunteers to evaluate the PF-06700841 effect on QTc interval. Each subject randomized will receive placebo, PF-06700841 200 mg and moxifloxacin (open label) in one of the 6 sequences. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-06700841 and moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Sep 2018to 6 Feb 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
- Healthy female subjects of non-childbearing potential and/or male subjects. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including BP and pulse rate measurement, 12-lead ECG, or clinical laboratory tests.
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb) at screening.
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic (including alcoholic liver disease, nonalcoholic steatohepatitis (NASH), autoimmune hepatitis, and hereditary liver diseases), psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing)
- Self-reported history or risk factors for QT prolongation or torsades de pointes (eg, organic heart disease, congestive heart failure, hypokalemia, hypomagnesaemia, congenital long QT syndrome, myocardial ischemia or infarction), congenital deafness, family history of sudden death, and family history of long QT syndrome.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product (whichever is longer)
- Subjects with known prior participation (ie, randomized and received at least 1 dose of investigational product) in a trial involving PF-06700841
- History of tuberculosis or active or latent or inadequately treated infection, positive QuantiFERON- tuberculosis (TB) Gold test
- History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb)
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing
- Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A PHASE 1, RANDOMIZED, PLACEBO-AND POSITIVE-CONTROLLED CROSSOVER STUDY TO DETERMINE THE EFFECT OF SINGLE-DOSE PF-06700841 ON QTC INTERVAL IN HEALTHY VOLUNTEERS
A phase 1, 6-sequence, 3-period, subject- and investigator blinded and sponsor-open, crossover study in healthy volunteers to evaluate the PF-06700841 effect on QTc interval. Each subject randomized will receive placebo, PF-06700841 200 mg and moxifloxacin (open label) in one of the 6 sequences. Moxifloxacin is positive control to demonstrate the study sensitivity and PF-06700841 effect on QTc will be assessed by concentration-QT analysis
- Conditions
- Healthy
- Being tested
- PF-06700841, Placebo, moxifloxacin
- Keywords
- PF-06700841, QT effect, concentration-QTc analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06700841Drug
a single oral dose of 200 mg PF-06700841
PlaceboDrug
Placebo matching PF-06700841
moxifloxacinDrug
a single oral dose of 400 mg moxifloxacin
| Study group | Role | What they receive |
|---|---|---|
| Seq 1 | Experimental | PF-06700841-> placebo-> moxifloxacin Receives: Drug: PF-06700841; Drug: Placebo; Drug: moxifloxacin |
| Seq 2 | Experimental | PF-06700841->moxifloxacin->placebo Receives: Drug: PF-06700841; Drug: Placebo; Drug: moxifloxacin |
| Seq 3 | Experimental | Placebo->PF-06700841->moxifloxacin Receives: Drug: PF-06700841; Drug: Placebo; Drug: moxifloxacin |
| Seq 4 | Experimental | Placebo->moxifloxacin->PF-06700841 Receives: Drug: PF-06700841; Drug: Placebo; Drug: moxifloxacin |
| Seq 5 | Experimental | Moxifloxacin->PF-06700841->placebo Receives: Drug: PF-06700841; Drug: Placebo; Drug: moxifloxacin |
| Seq 6 | Experimental | Moxifloxacin->placebo->PF-06700841 Receives: Drug: PF-06700841; Drug: Placebo; Drug: moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
QTc change from baseline following PF-06700841 treatment
QTc change from baseline at geometric mean of maximum concentrations observed after single doses of 200 mg PF-06700841 and maximum concentrations expected at lower doses of 30 and 60 mg.
Measured: 0 to 48 hours post-dose
Secondary outcomes (1)
QTc change from baseline following moxifloxacin treatment
QTc change from baseline at 3 hours (Tmax) after a single dose of 400 mg moxifloxacin administration
Measured: 0-48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start5 Sep 2018
- Primary completion6 Feb 2019
- Study completion6 Feb 2019
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 HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 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
- NCT03656952
- Sponsor's protocol ID
- B7931019
- Other IDs
- 2018-001932-23, 2018
- Status last verified
- Feb 2019
- First submitted
- 30 Aug 2018
- Last updated
- 27 Feb 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.
Publications
Hughes JH, Qiu R, Banfield C, Dowty ME, Nicholas T. Population Pharmacokinetics of Oral Brepocitinib in Healthy Volunteers and Patients. Clin Pharmacol Drug Dev. 2022 Dec;11(12):1447-1456. doi: 10.1002/cpdd.1163. Epub 2022 Aug 31.
PubMed 36045513
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, RANDOMIZED, PLACEBO-AND POSITIVE-CONTROLLED CROSSOVER STUDY TO DETERMINE THE EFFECT OF SINGLE-DOSE PF-06700841 ON QTC INTERVAL IN HEALTHY VOLUNTEERS
- ClinicalTrials.gov ID
- NCT03656952
- Acronym / sponsor ID
- B7931019
- Conditions
- Healthy
- Keywords
- PF-06700841, QT effect, concentration-QTc analysis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 6 Feb 2019 (actual)
- Study completion
- 6 Feb 2019 (actual)
- First posted
- 4 Sep 2018 (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.
A phase 1, 6-sequence, 3-period, subject- and investigator blinded and sponsor-open, crossover study in healthy volunteers to evaluate the PF-06700841 effect on QTc interval. Each subject randomized will receive placebo, PF-06700841 200 mg and moxifloxacin (open label) in one of the 6 sequences. Moxifloxacin is positive control to demonstrate the study sensitivity and PF-06700841 effect on QTc will be assessed by concentration-QT analysis
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Seq 1 | Experimental | Drug: PF-06700841, Drug: Placebo, Drug: moxifloxacinPF-06700841-> placebo-> moxifloxacin |
| Seq 2 | Experimental | Drug: PF-06700841, Drug: Placebo, Drug: moxifloxacinPF-06700841->moxifloxacin->placebo |
| Seq 3 | Experimental | Drug: PF-06700841, Drug: Placebo, Drug: moxifloxacinPlacebo->PF-06700841->moxifloxacin |
| Seq 4 | Experimental | Drug: PF-06700841, Drug: Placebo, Drug: moxifloxacinPlacebo->moxifloxacin->PF-06700841 |
| Seq 5 | Experimental | Drug: PF-06700841, Drug: Placebo, Drug: moxifloxacinMoxifloxacin->PF-06700841->placebo |
| Seq 6 | Experimental | Drug: PF-06700841, Drug: Placebo, Drug: moxifloxacinMoxifloxacin->placebo->PF-06700841 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy female subjects of non-childbearing potential and/or male subjects. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including BP and pulse rate measurement, 12-lead ECG, or clinical laboratory tests.
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb) at screening.
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Key exclusion criteria (8 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic (including alcoholic liver disease, nonalcoholic steatohepatitis (NASH), autoimmune hepatitis, and hereditary liver diseases), psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing)
- Self-reported history or risk factors for QT prolongation or torsades de pointes (eg, organic heart disease, congestive heart failure, hypokalemia, hypomagnesaemia, congenital long QT syndrome, myocardial ischemia or infarction), congenital deafness, family history of sudden death, and family history of long QT syndrome.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product (whichever is longer)
- Subjects with known prior participation (ie, randomized and received at least 1 dose of investigational product) in a trial involving PF-06700841
- History of tuberculosis or active or latent or inadequately treated infection, positive QuantiFERON- tuberculosis (TB) Gold test
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-06700841a single oral dose of 200 mg PF-06700841 | Drug | Seq 1, Seq 2, Seq 3, Seq 4, Seq 5, Seq 6 |
| PlaceboPlacebo matching PF-06700841 | Drug | Seq 1, Seq 2, Seq 3, Seq 4, Seq 5, Seq 6 |
| moxifloxacina single oral dose of 400 mg moxifloxacin | Drug | Seq 1, Seq 2, Seq 3, Seq 4, Seq 5, Seq 6 |
Primary outcome
QTc change from baseline following PF-06700841 treatment
Time frame: 0 to 48 hours post-dose
QTc change from baseline at geometric mean of maximum concentrations observed after single doses of 200 mg PF-06700841 and maximum concentrations expected at lower doses of 30 and 60 mg.
1 secondary outcome
QTc change from baseline following moxifloxacin treatment
Time frame: 0-48 hours post-dose
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 27 Feb 2019.
- Derived from this study: PubMed 36045513Hughes JH, Qiu R, Banfield C, Dowty ME, Nicholas T. Population Pharmacokinetics of Oral Brepocitinib in Healthy Volunteers and Patients. Clin Pharmacol Drug Dev. 2022 Dec;11(12):1447-1456. doi: 10.1002/cpdd.1163. Epub 2022 Aug 31.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- 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.
Related trials for Healthy
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingObservational study
Study of New Magnetic Resonance Imaging Methods of the Brain
Healthy Volunteer, Magnetic Resonance Imaging
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
RecruitingObservational study
Cytapheresis of Volunteer Donors
Healthy Volunteers
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
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-06700841 and moxifloxacin in people with Healthy, 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 4 inclusion and 8 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 27 Feb 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?
QTc change from baseline following PF-06700841 treatment (time frame: 0 to 48 hours post-dose). 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 NCT03656952, 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 27 Feb 2019; AzTrials last refreshed its copy on 30 Oct 2026.