Single Dose Study of PF-06815345 in Healthy Subjects

Hypercholesterolemia Clinical Trial

Official title:

A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06815345, As Well As Characterize The Pharmacokinetics Of Two Formulations And Effect Of Food On Pharmacokinetics Of One Formulation Of Pf‑06815345 Administered To Healthy Adult Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02654899
• Other study ID #: C0281001
• Secondary ID: 2015-003935-36
• Status: Terminated
• Phase: Phase 1
• Start date: November 2015
• Est. completion date: March 2016

Study information

• Verified date: September 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current study is the first clinical trial proposed with PF-06815345. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single oral doses of PF-06815345 to healthy adult subjects.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy males and female of non-childbearing potential;

• Age of 18-55, inclusive;

• Body Mass Index 17.5-34.9 kg/m2, inclusive;

• Body weight >50 kg;

• Not on any prescription or non-prescription drugs within 7 days or 5 half-lives prior to first dose.

Exclusion Criteria:

• Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• PF-06815345
PF-06815345 will be administered as a liquid dosage formulation

Other:
• Placebo
Placebo

Drug:
• PF-06815345
PF-06815345 will be administered as either solid dosage formulation or liquid dosage formulation

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs)	Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.	Baseline (Day 0) up to 28 days after last dose of study medication
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06815345	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Secondary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-06815345	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, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Secondary	Maximum Observed Plasma Concentration (Cmax) for PF-06815345	Maximum Observed Plasma Concentration (Cmax)	0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Secondary	Time to Reach Maximum Observed Concentration for PF-06815345	Time to Reach Maximum Observed Plasma Concentration (Tmax)	0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Secondary	Plasma Decay Half-Life (t1/2) for PF-06815345	Plasma Decay Half-Life (t1/2)	0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Secondary	Apparent Oral Clearance (CL/F) for PF-06815345	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, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Secondary	Apparent Volume of Distribution (Vz/F) for PF-06815345	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, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for the metabolite (PF-06811701)	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Secondary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for metabolite (PF-06811701)	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, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Secondary	Maximum Observed Plasma Concentration (Cmax) for metabolite (PF-06811701)	Maximum Observed Plasma Concentration (Cmax)	0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Secondary	Time to Reach Maximum Observed Concentration for metabolite (PF-06811701)	Time to Reach Maximum Observed Plasma Concentration (Tmax)	0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Secondary	Plasma Decay Half-Life (t1/2) for metabolite (PF-06811701)	Plasma Decay Half-Life (t1/2)	0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose

External Links

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