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HealthyPhase 1NCT01992614

A Single Dose Study Of PF-06678552 In Healthy Subjects

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

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

PF-06678552 is a new compound proposed for the treatment of hypercholesteremia. The primary purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06678552 in healthy 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
24 participants
Where
1 siteBelgium
Study dates
Dec 2013to Mar 2014
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 and/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
  • Low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL

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 Investigational Site

    Brussels, B-1070

Other trials in Belgium

About this study

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PF-06678552 After Fed And Fasted Administration Of Single Escalating Oral Doses In Healthy Subjects

PF-06678552 is a new compound proposed for the treatment of hypercholesteremia. The primary purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06678552 in healthy subjects.

Conditions
Healthy
Being tested
PF-06678552 or Placebo
Keywords
Single Ascending Dose, healthy subjects, Hypercholesterolemia, Hyperlipidemias, Dyslipidemias, Lipid Metabolism Disorders, Metabolic Diseases
Medical subject headings
Hypercholesterolemia, Hyperlipidemias, Dyslipidemias, Lipid Metabolism Disorders, Metabolic Diseases

What participants receive

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

  • PF-06678552 or PlaceboDrug

    PF-06678552 or placebo will be administered as an extemporaneously prepared solution once in each period.

  • PF-06678552 or PlaceboDrug

    PF-06678552 or placebo will be administered as an extemporaneously prepared solution once in each period.

  • PF-06678552 or PlaceboDrug

    PF-06678552 or placebo will be administered as an extemporaneously prepared solution once in each period.

Study groups in NCT01992614
Study groupRoleWhat they receive
Cohort 1ExperimentalSingle ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD.
Receives: Drug: PF-06678552 or Placebo
Cohort 2ExperimentalSingle ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD.
Receives: Drug: PF-06678552 or Placebo
Cohort 3ExperimentalSingle ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD.
Receives: Drug: PF-06678552 or Placebo

What is being measured

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

  1. Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate) and cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).

    Measured: 0 to 72 hours post dose

Secondary outcomes (15)

  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552

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

    Measured: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

  2. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] for PF-06678552

    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, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

  3. Maximum Observed Plasma Concentration (Cmax) for for PF-06678552

    Maximum Observed Plasma Concentration (Cmax)

    Measured: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

  4. Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552

    Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Measured: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

  5. Plasma Decay Half-Life (t1/2) for PF-06678552

    Plasma Decay Half-Life (t1/2)

    Measured: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

  6. Apparent Oral Clearance (CL/F) for PF-06678552

    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, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

  7. Apparent Volume of Distribution (Vz/F) for PF-06678552

    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, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

  8. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927

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

    Measured: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

  9. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] for PF-06644927

    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, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

  10. Maximum Observed Plasma Concentration (Cmax) for PF-06644927

    Maximum Observed Plasma Concentration (Cmax)

    Measured: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

  11. Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927

    Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Measured: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

  12. Plasma Decay Half-Life (t1/2) for PF-06644927

    Plasma Decay Half-Life (t1/2)

    Measured: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

  13. Amount of PF-06644927 excreted in the urine (Ae)

    Amount of drug excreted in the urine is a measure of the degree that the kidneys filter drug from the blood to the urine.

    Measured: 0-4, 4-12, and 12-24 hours post dose

  14. Percent of PF-06678552 dose excreted in the urine as PF-06644927 (Ae%)

    The percent of PF-06678552 dose excreted in the urine as PF-06644927 is calculated from the mass of dose excreted in the urine compared to the total dose of PF-06678552 and corrected for the relative weight of PF-06644927 to PF-06678552.

    Measured: 0-4, 4-12, and 12-24 hours post dose

  15. Renal Clearance (CLr) for PF-06644927

    Renal clearance is the measure of the rate of drug moving into the urine from blood

    Measured: 0-4, 4-12, and 12-24 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 posted25 Nov 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionMar 2014
  4. Study completionMar 2014

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01992614
Sponsor's protocol ID
B7611001
Status last verified
Mar 2014
First submitted
19 Nov 2013
Last updated
28 Mar 2014
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 3 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: finished, as of the sponsor's last update on 28 Mar 2014. 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?

Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate) and cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG). (time frame: 0 to 72 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 NCT01992614.

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 28 Mar 2014.

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