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Healthy SubjectsPhase 1NCT03492697

A Single Dose Crossover Study In Healthy Subjects To Evaluate Different Formulations Of PF-06882961

A Phase 1 study testing PF-06882961 Immediate Release Tablet and PF-06882961 Immediate Release Solution in people with Healthy Subjects, 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

This open label study will evaluate the pharmacokinetics (PK) following single oral doses of different formulations of PF-06882961, including controlled release (CR) tablets at 2 release rates (long and short duration), an immediate release (IR) oral solution, and IR tablets, 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 Subjects
What is being tested?
PF-06882961 Immediate Release Tablet and PF-06882961 Immediate Release Solution
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
30 Apr 2018to 18 Jul 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 nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive
  • Body mass index (BMI) within 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study

Who cannot join

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal (including pancreatitis), cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug test.
  • History of regular alcohol consumption exceeding 7 drinks/week for female subjects or 14 drinks/week for male subjects within 6 months before screening.
  • 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 who have previously participated in prior studies with PF 06882961 as the investigational product.
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  • 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 QTc interval >450 msec or a QRS interval >120 msec.
  • Aspartate aminotransferase (AST) level >= 1.25 × upper limit of normal (ULN);
  • Alanine aminotransferase (ALT) level >= 1.25 × ULN;
  • Total bilirubin level >=1.5 × ULN;
  • TSH > ULN;
  • HbA1c >=6.5%.
  • Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in the protocol for at least 28 days after the last dose of investigational product.
  • 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 investigational product
  • Blood donation (excluding plasma donations) 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 (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb).
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), or subjects with suspected MTC per the investigator's judgement.
  • Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of the protocol.
  • Subjects who are investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
  • 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.

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, Open-label Study In Healthy Subjects To Evaluate The Pharmacokinetics Of Pf-06882961 Following Single Oral Administration Of Immediate Release Tablets And An Immediate Release Oral Solution In The Fed State, And Controlled Release Tablets In The Fed And Fasted States

This open label study will evaluate the pharmacokinetics (PK) following single oral doses of different formulations of PF-06882961, including controlled release (CR) tablets at 2 release rates (long and short duration), an immediate release (IR) oral solution, and IR tablets, in healthy adult subjects.

Being tested
PF-06882961 Immediate Release Tablet, PF-06882961 Controlled Release Tablet (long), PF-06882961 Controlled Release Tablet (short), PF-06882961 Immediate Release Solution

What participants receive

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

  • PF-06882961 Immediate Release TabletDrug

    Immediate Release Tablet

  • PF-06882961 Controlled Release Tablet (long)Drug

    Controlled Release tablet (long)

  • PF-06882961 Controlled Release Tablet (short)Drug

    Controlled Release tablet (short)

  • PF-06882961 Immediate Release SolutionDrug

    PF-06882961 Immediate Release solution

Study groups in NCT03492697
Study groupRoleWhat they receive
PF-06882961ExperimentalNot described
Receives: Drug: PF-06882961 Immediate Release Tablet; Drug: PF-06882961 Controlled Release Tablet (long); Drug: PF-06882961 Controlled Release Tablet (short); Drug: PF-06882961 Immediate Release Solution

What is being measured

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

  1. Maximum Observed Plasma Concentration (Cmax) for PF-06882961

    Measured: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

  2. Time to Maximum Observed Plasma Concentration (Tmax) for PF-06882961

    Measured: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

  3. Area under the curve from time zero to last quantifiable concentration for PF-06882961 (AUClast)

    Measured: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

  4. Area under the curve from time zero to extrapolated infinite time for PF-06882961 (AUCinf), as data permit

    AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).

    Measured: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

  5. Observed Plasma Concentration for PF-06882961 at 24 hours post-dose (C24)

    Measured: 24 hours post dose in each period

  6. Plasma Decay Half-Life (t1/2) for PF-06882961, as data permit

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

    Measured: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

  7. Apparent clearance (CL/F) for PF-06882961, as data permit

    Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Calculated as Dose/AUCinf

    Measured: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

  8. Peak-to-trough (PTR) ratio for PF-06882961

    Calculated as ratio of Cmax to C24

    Measured: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

Secondary outcomes (7)

  1. Number of subjects with treatment-emergent adverse events (AEs)

    Assessment by adverse event monitoring, 12 lead ECGs, vital signs and clinical safety laboratory measurements.

    Measured: Baseline to at least 28 days after last dose

  2. AUClast for PF-06882961 for CR tablet (long) and IR tablet in fed state

    Measured: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose

  3. AUCinf for PF-06882961 for CR tablet (long) and IR tablet in fed state, as data permit

    Measured: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose

  4. Cmax for PF-06882961 for CR tablet (long) and IR tablet in fed state

    Measured: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose

  5. AUClast for PF-06882961 for CR tablet (long) in fed and fasted states

    Measured: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose

  6. AUCinf for PF-06882961 for CR tablet (long) in fed and fasted states, as data permit

    Measured: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose

  7. Cmax for PF-06882961 for CR tablet (long) in fed and fasted states

    Measured: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 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.

  1. First posted10 Apr 2018
  2. Study start30 Apr 2018
  3. Primary completion18 Jul 2018
  4. Study completion18 Jul 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
Crossover
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03492697
Sponsor's protocol ID
C3421003
Status last verified
Jul 2018
First submitted
3 Apr 2018
Last updated
30 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-06882961 Immediate Release Tablet and PF-06882961 Immediate Release Solution in people with Healthy Subjects, 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 3 inclusion and 22 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 30 Jul 2018. 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?

Maximum Observed Plasma Concentration (Cmax) for PF-06882961 (time frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period). The study lists 8 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 NCT03492697.

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 30 Jul 2018.

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Clinical Trial NCT03492697 | AzTrials