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Healthy VolunteersPhase 1NCT03351751

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Repeat Doses of PF-06372865 in Healthy Subjects

A Phase 1 study testing PF-06372865 in people with Healthy Volunteers, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple repeat oral doses of PF-06372865 in healthy adult subjects. 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-06372865
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
19 participants
Where
1 siteUnited States
Study dates
8 Nov 2017to 28 Feb 2018
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 between the ages of 18 and 55 years
  • Body mass index of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
  • Subjects who are willing and able to comply with all study procedures (including being able to swallow up to 8 tablets/dose or 16 tablets/day)
  • For optional Japanese subjects only: Japanese subjects currently residing in the United States who have 4 biologic Japanese grandparents born in Japan

Who cannot join

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
  • Subjects with history of sleep apnea
  • Any condition possibly affecting drug absorption (eg, gastrectomy)
  • Positive urine drug test
  • History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males
  • Treatment with an investigational drug within 30 days or 5 half-lives of the first dose of PF-06372865 (whichever is longer)
Show all 23Show fewer
  • Clinically significant orthostatic hypotension at screening or screening supine BP >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of supine rest
  • Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval >450 msec or a QRS interval >120 msec
  • Subjects with any of the following abnormalities in clinical laboratory tests at screening: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level >=1.5x upper limit of normal (ULN); total bilirubin level >=1.5x ULN; subjects with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is <=ULN
  • Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 60 days after the last dose of PF-06372865
  • Male subjects whose partners are currently pregnant
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of PF-06372865
  • Use of herbal supplements or hormone replacement therapy within 28 days prior to the first dose of PF-06372865
  • Blood donation of approximately 1 pint (500 mL) or more within 60 days prior to dosing
  • History of sensitivity to heparin or heparin-induced thrombocytopenia
  • History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody
  • Other acute or chronic medical or psychiatric condition including recent or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or PF-06372865 administration or may interfere with the interpretation of study results
  • Subjects with active suicidal ideations or suicidal behavior within 5 years prior to screening
  • Subjects with history of cyclic neutropenia.
  • Subjects with known history of hypersensitivity to benzodiazepines, or for whom benzodiazepines would be contraindicated
  • Subjects who have previously been exposed to, or participated in a study with, PF-06372865
  • Subjects with folate deficiency
  • Subjects who have had an X-ray within 4 weeks prior to screening

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pfizer New Haven Clinical Research Unit

    New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: A PHASE 1, DOUBLE-BLIND (3RD PARTY OPEN), RANDOMIZED, PLACEBO-CONTROLLED, DOSE ESCALATION STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF REPEAT ORAL DOSES OF PF-06372865 IN HEALTHY ADULT SUBJECTS

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple repeat oral doses of PF-06372865 in healthy adult subjects.

Being tested
Placebo, PF-06372865
Keywords
PF-06372865, Safety, Tolerability, Pharmacokinetics, Multiple dose, Healthy subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo

  • PF-06372865Drug

    PF-06372865

Study groups in NCT03351751
Study groupRoleWhat they receive
PlaceboPlacebo comparatorSubjects receiving placebo
Receives: Drug: Placebo
PF-06372865ExperimentalSubjects receiving PF-06372865
Receives: Drug: PF-06372865

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

    Treatment-related AEs are any untoward medical occurrences attributed to study drug in a participant who received study drug. A serious adverse events (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28-35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to study drug is assessed by the investigator. Participants with multiple occurrences of an AE within a category are counted once within the category.

    Measured: Baseline up to 28-35 days after last dose of study medication

  2. Change From Baseline in Vital Signs

    Measurement of systolic and diastolic blood pressure and pulse rate

    Measured: 0, 1, 2, 4, 8, and 12 hours post-dose on Days 1 and 21; also 0 and 2 hours post-dose on Days 4, 8, 11, 14, and 17

  3. Change From Baseline in Electrocardiogram (ECG) Parameters

    Measurement of the following ECG parameters: QT interval, QTcF, PR interval, RR interval, QRS interval, and heart rate.

    Measured: 0, 1, 2, 4, 8, and 12 hours post-dose on Days 1 and 21; also 0 and 2 hours post-dose on Days 4, 8, 11, 14, and 17

  4. Number of Participants With Clinical Laboratory Abnormalities

    Lab tests include: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein, folate); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity [pH], glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy); other (follicle stimulating hormone, urine drug screening, hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, human immunodeficiency virus).

    Measured: Baseline up to 7-10 days after last dose of study medication

  5. Maximum Observed Plasma Concentration (Cmax) for PF-06372865 on Day 1

    Maximum observed plasma concentration

    Measured: 0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose

  6. Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06372865 on Day 1

    Time to reach maximum observed plasma concentration

    Measured: 0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose

  7. Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for PF-06372865 on Day 1

    Area under the concentration curve from time 0 to end of the dosing interval. The dosing interval is 12 hours.

    Measured: 0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose

  8. Maximum Observed Plasma Concentration (Cmax) for PF-06372865 on Day 21

    Maximum observed plasma concentration

    Measured: 0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose

  9. Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06372865 on Day 21

    Time to reach maximum observed plasma concentration

    Measured: 0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose

  10. Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for PF-06372865 on Day 21

    Area under the concentration curve from time 0 to end of the dosing interval. The dosing interval is 12 hours.

    Measured: 0, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours post-dose

  11. Plasma Half-Life (t1/2)

    Time for the plasma concentration to decrease by one half.

    Measured: 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2017
  2. Study start8 Nov 2017
  3. Primary completion28 Feb 2018
  4. Study completion28 Feb 2018

Resources

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
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03351751
Sponsor's protocol ID
B7431011
Status last verified
May 2019
First submitted
13 Oct 2017
Last updated
3 Jun 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-06372865 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 4 inclusion and 23 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 3 Jun 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 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. Some participants in this study may receive a placebo. 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?

Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) (time frame: Baseline up to 28-35 days after last dose of study medication). The study lists 11 primary outcomes in all. 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 NCT03351751.

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 3 Jun 2019.

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