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HealthyPhase 1NCT02286882

A Single Oral Dose Study Of PF-06409577 In Healthy Adult Subjects

A Phase 1 study of Healthy, run by Pfizer at 1 site in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

PF-06409577 is a new compound proposed for the treatment of diabetic nephropathy. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of PF-06409577 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
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
39 participants
Where
1 siteBelgium
Study dates
Nov 2014to Jun 2015
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 male, or female subjects of non childbearing potential.
  • Body Mass Index (BMI) of 18 to 30.5 kg/m2; and a total body weight >50 kg

Who cannot join

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Pfizer Clinical Research Unit

    Brussels, B-1070

Other trials in Belgium

About this study

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Ascending Oral Doses Of Pf-06409577 In Healthy Adult Subjects

PF-06409577 is a new compound proposed for the treatment of diabetic nephropathy. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of PF-06409577 in healthy adult subjects.

Conditions
Healthy
Being tested
PF-06409577 or Placebo
Keywords
Single Ascending Dose, healthy subjects

What participants receive

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

  • PF-06409577 or PlaceboDrug

    PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort

Study groups in NCT02286882
Study groupRoleWhat they receive
Cohort 1: PF-06409577 or placeboExperimentalSingle ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
Receives: Drug: PF-06409577 or Placebo
Cohort 2: PF-06409577 or placeboExperimentalSingle ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
Receives: Drug: PF-06409577 or Placebo
Cohort 3: PF-06409577 or placeboExperimentalSingle ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
Receives: Drug: PF-06409577 or Placebo
Cohort 4: PF-06409577 or placeboExperimentalSingle ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
Receives: Drug: PF-06409577 or Placebo
Cohort 5: PF-06409577 or placeboExperimentalSingle ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
Receives: Drug: PF-06409577 or Placebo
Cohort 6: PF-06409577 or placeboExperimentalSingle ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
Receives: Drug: PF-06409577 or Placebo
Cohort 7: PF-06409577 or placeboExperimentalSingle ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
Receives: Drug: PF-06409577 or Placebo
Cohort 8: PF-06409577 or placeboExperimentalSingle ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
Receives: Drug: PF-06409577 or Placebo
Cohort 9: PF-06409577 or placeboExperimentalSingle ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
Receives: Drug: PF-06409577 or Placebo

What is being measured

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

  1. Number of Participants With Adverse Events (AEs)

    Measured: 0-48 hours post dose

  2. Number of Participants With Laboratory Test Values of Potential Clinical Importance

    Measured: 0-48 hours post dose

  3. Number of Participants With Vital Signs Findings (Including Bood Pressure and Pulse Rate) of Potential Clinical Importance

    Measured: 0-48 hours post dose

  4. Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance

    Measured: 0-48 hours post dose

  5. Number of Participants With Echocardiogram Findings of Potential Clinical Importance

    Measured: 0-48 hours post dose

Secondary outcomes (11)

  1. Area Under the Curve From Time Zero to Time 24 hours (AUC24) for PF-06409577

    Area under the plasma concentration time-curve from zero to time 24 hours post dose (AUC24)

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose

  2. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06409577

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

  3. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] for PF-06409577

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

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

  4. Maximum Observed Plasma Concentration (Cmax) for PF-06409577

    Maximum Observed Plasma Concentration (Cmax)

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

  5. Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06409577

    Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

  6. Plasma Decay Half-Life (t1/2) for PF-06409577

    Plasma Decay Half-Life (t1/2)

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

  7. Apparent Oral Clearance (CL/F) for PF-06409577

    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

  8. Apparent Volume of Distribution (Vz/F) for PF-06409577

    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

  9. Total amount of PF-06409577 excreted in the urine over 24 hours (Ae24)

    Total amount of unchanged drug excreted in the urine over 24 hours.

    Measured: 0-24 hours post dose

  10. Total amount of PF-06409577 excreted in the urine over 24 hours, expressed as percent of dose (%Ae24)

    Total amount of unchanged drug excreted in the urine over 24 hours, expressed as percent of dose.

    Measured: 0-24 hours post dose

  11. Renal clearance for PF-06409577

    Renal clearance of a drug is a measure of the rate at which a drug is excreted unchanged into urine.

    Measured: 0-24 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 Nov 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionJun 2015
  4. Study completionJun 2015

Why it stopped: The trial was terminated prematurely on June 19, 2015 for business reasons. There were no safety concerns in the study which led to the decision.

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
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02286882
Sponsor's protocol ID
B7881001
Other IDs
FIH, 2014-004022-18, 2014
Status last verified
Jul 2015
First submitted
6 Nov 2014
Last updated
20 Jul 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 20 Jul 2015. 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 was stopped early (reason given: The trial was terminated prematurely on June 19, 2015 for business reasons. There were no safety concerns in the study which led to the decision.). Results are not available in the source record.

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 Adverse Events (AEs) (time frame: 0-48 hours post dose). The study lists 5 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 NCT02286882.

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 20 Jul 2015.

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