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A Multiple Dose Study Of PF-06678552 In Healthy Subjects

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02079922
Enrollment
38
Registered
2014-03-06
Start date
2014-03-31
Completion date
2014-07-31
Last updated
2014-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Multiple Ascending Dose, healthy subjects, Hypercholesterolemia, Hyperlipidemias, Dyslipidemias, Lipid Metabolism Disorders, Metabolic Diseases

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.

Interventions

DRUGPF-06678552

PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.

DRUGPlacebo

PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
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)

Design outcomes

Primary

MeasureTime frame
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.0 to 24 days post dose

Secondary

MeasureTime frameDescription
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 70, 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 140, 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 10, 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 70, 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 140, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose—
Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 10, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose—
Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 70, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose—
Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 140, 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 10, 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 70, 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 140, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose—
Plasma Decay Half-Life (t1/2) for PF-06644927 on day 140, 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 10, 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 10, 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 10, 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 10, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose—
Amount of PF-06644927 excreted in urine (Ae) on day 140-12 hours post dose—
Percent of dose excreted in urine as PF-06644927 (Ae%) on day 140-12 hours post dose—
Renal clearance of PF-06644927 (CLr) on day 140-12 hours post dose—
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 10, 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 70, 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 140, 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 10, 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 70, 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 140, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose—
Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 10, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose—
Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 70, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose—
Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 140, 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 10, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose—
Apparent Oral Clearance (CL/F) of PF-06678552 on day 140, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post doseClearance 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. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552 on day 70, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose—
Plasma Decay Half-Life (t1/2) for PF-06678552 on day 140, 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-06678552 on day 7 relative to day 10, 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 10, 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 10, 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 10, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose—
Apparent Oral Clearance (CL/F) of PF-06678552 on day 70, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post doseClearance 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. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Apparent Volume of Distribution (Vz/F) of PF-06678552 on day 70, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post doseVolume 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.
Apparent Volume of Distribution (Vz/F) of PF-06678552 on day 140, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post doseVolume 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.
Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06678552 on day 7 relative to day 10, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose—

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026