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Clinical Trials/NCT02079922
NCT02079922CompletedPhase 1

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PF-06678552 After Administration Of Multiple Escalating Oral Doses In Healthy Adult Subjects

Pfizer1 site in 1 country38 target enrollmentStarted: March 2014Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Pfizer
Enrollment
38
Locations
1
Primary Endpoint
Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate), and cardiac conduction intervals as assessed by 12 lead ECG.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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 multiple oral doses of PF-06678552 in healthy subjects.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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)

Arms & Interventions

Cohort 1

Experimental

Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Intervention: PF-06678552 (Drug)

Cohort 1

Experimental

Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Intervention: Placebo (Drug)

Cohort 2

Experimental

Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Intervention: PF-06678552 (Drug)

Cohort 2

Experimental

Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Intervention: Placebo (Drug)

Cohort 3

Experimental

Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Intervention: PF-06678552 (Drug)

Cohort 3

Experimental

Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Intervention: Placebo (Drug)

Cohort 4

Experimental

Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Intervention: PF-06678552 (Drug)

Cohort 4

Experimental

Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Intervention: Placebo (Drug)

Cohort 5

Experimental

Single dose level of PF-06678552 or placebo will be provided either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Intervention: PF-06678552 (Drug)

Cohort 5

Experimental

Single dose level of PF-06678552 or placebo will be provided either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Intervention: Placebo (Drug)

Cohort 6

Experimental

Single dose level of PF-06678552 or placebo will be provided either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Intervention: PF-06678552 (Drug)

Cohort 6

Experimental

Single dose level of PF-06678552 or placebo will be provided either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

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

Time Frame: 0 to 24 days post dose

Secondary Outcomes

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 7(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06644927 on day 7 relative to day 1(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06644927 on day 14 relative to day 1(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Amount of PF-06644927 excreted in urine (Ae) on day 14(0-12 hours post dose)
  • Percent of dose excreted in urine as PF-06644927 (Ae%) on day 14(0-12 hours post dose)
  • Renal clearance of PF-06644927 (CLr) on day 14(0-12 hours post dose)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 1(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 7(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 14(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Area Under the Curve during the dosing interval (AUCtau) for PF-06678552 on day 7(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Area Under the Curve during the dosing interval (AUCtau) for PF-06678552 on day 14(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 1(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06678552 on day 14 relative to day 1(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 14(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06678552 on day 7 relative to day 1(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06678552 on day 14 relative to day 1(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Area Under the Curve during the dosing interval (AUCtau) for PF-06678552 on day 1(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 7(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06678552 on day 7 relative to day 1(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Apparent Oral Clearance (CL/F) of PF-06678552 on day 14(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Apparent Volume of Distribution (Vz/F) of PF-06678552 on day 14(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552 on day 1(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552 on day 7(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Plasma Decay Half-Life (t1/2) for PF-06678552 on day 14(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose)
  • Apparent Oral Clearance (CL/F) of PF-06678552 on day 7(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Apparent Volume of Distribution (Vz/F) of PF-06678552 on day 7(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 14(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 1(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 14(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 1(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 1(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 7(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 14(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 1(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 7(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 14(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Plasma Decay Half-Life (t1/2) for PF-06644927 on day 14(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose)
  • Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06644927 on day 7 relative to day 1(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06644927 on day 14 relative to day 1(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)
  • Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 7(0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose)

Investigators

Sponsor
Pfizer
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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