A Single 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 Fed And Fasted Administration Of Single Escalating Oral Doses In Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01992614
• Other study ID #: B7611001
• Status: Completed
• Phase: Phase 1
• First received: November 19, 2013
• Last updated: March 27, 2014
• Start date: December 2013
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: 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 single oral doses of PF-06678552 in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2014
• Est. primary completion date: March 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: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

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

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 via 12-lead electrocardiogram (ECG).		0 to 72 hours post dose	Yes
Secondary	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)	0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose	No
Secondary	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).	0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose	No
Secondary	Maximum Observed Plasma Concentration (Cmax) for for PF-06678552	Maximum Observed Plasma Concentration (Cmax)	0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552	Time to Reach Maximum Observed Plasma Concentration (Tmax)	0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose	No
Secondary	Plasma Decay Half-Life (t1/2) for PF-06678552	Plasma Decay Half-Life (t1/2)	0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose	No
Secondary	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.	0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose	No
Secondary	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.	0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose	No
Secondary	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)	0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose	No
Secondary	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).	0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose	No
Secondary	Maximum Observed Plasma Concentration (Cmax) for PF-06644927	Maximum Observed Plasma Concentration (Cmax)	0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927	Time to Reach Maximum Observed Plasma Concentration (Tmax)	0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose	No
Secondary	Plasma Decay Half-Life (t1/2) for PF-06644927	Plasma Decay Half-Life (t1/2)	0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose	No
Secondary	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.	0-4, 4-12, and 12-24 hours post dose	No
Secondary	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.	0-4, 4-12, and 12-24 hours post dose	No
Secondary	Renal Clearance (CLr) for PF-06644927	Renal clearance is the measure of the rate of drug moving into the urine from blood	0-4, 4-12, and 12-24 hours post dose	No

External Links

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