A Multiple Dose Study Of PF-06678552 In Healthy Subjects

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02079922
• Other study ID #: B7611002
• Status: Completed
• Phase: Phase 1
• First received: March 4, 2014
• Last updated: July 29, 2014
• Start date: March 2014
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeBelgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-06678552
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
• Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
• PF-06678552
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
• Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
• PF-06678552
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
• Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
• PF-06678552
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
• Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
• PF-06678552
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
• Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
• PF-06678552
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
• Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Amount of PF-06644927 excreted in urine (Ae) on day 14		0-12 hours post dose	No
Secondary	Percent of dose excreted in urine as PF-06644927 (Ae%) on day 14		0-12 hours post dose	No
Secondary	Renal clearance of PF-06644927 (CLr) on day 14		0-12 hours post dose	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Apparent Oral Clearance (CL/F) of PF-06678552 on day 7	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. 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.	0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose	No
Secondary	Apparent Oral Clearance (CL/F) of PF-06678552 on day 14	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. 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.	0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose	No
Secondary	Apparent Volume of Distribution (Vz/F) of PF-06678552 on day 7	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.	0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose	No
Secondary	Apparent Volume of Distribution (Vz/F) of PF-06678552 on day 14	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.	0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose	No

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