A Single Oral Dose Study Of PF-06409577 In Healthy Adult Subjects

Healthy Clinical Trial

Official title:

A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Ascending Oral Doses Of Pf-06409577 In Healthy Adult Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02286882
• Other study ID #: B7881001
• Secondary ID: FIH2014-004022-1
• Status: Terminated
• Phase: Phase 1
• First received: November 6, 2014
• Last updated: July 16, 2015
• Start date: November 2014
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• 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-06409577 is a new compound proposed for the treatment of diabetic nephropathy. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of PF-06409577 in healthy adult subjects.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male, 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

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 Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-06409577 or Placebo
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort

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 Participants With Adverse Events (AEs)		0-48 hours post dose	Yes
Primary	Number of Participants With Laboratory Test Values of Potential Clinical Importance		0-48 hours post dose	Yes
Primary	Number of Participants With Vital Signs Findings (Including Bood Pressure and Pulse Rate) of Potential Clinical Importance		0-48 hours post dose	Yes
Primary	Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance		0-48 hours post dose	Yes
Primary	Number of Participants With Echocardiogram Findings of Potential Clinical Importance		0-48 hours post dose	Yes
Secondary	Area Under the Curve From Time Zero to Time 24 hours (AUC24) for PF-06409577	Area under the plasma concentration time-curve from zero to time 24 hours post dose (AUC24)	0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose	No
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06409577	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	0, 0.5, 1, 2, 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-06409577	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, 8, 12, 16, 24, 36, 48 hours post dose	No
Secondary	Maximum Observed Plasma Concentration (Cmax) for PF-06409577	Maximum Observed Plasma Concentration (Cmax)	0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06409577	Time to Reach Maximum Observed Plasma Concentration (Tmax)	0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose	No
Secondary	Plasma Decay Half-Life (t1/2) for PF-06409577	Plasma Decay Half-Life (t1/2)	0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose	No
Secondary	Apparent Oral Clearance (CL/F) for PF-06409577	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, 8, 12, 16, 24, 36, 48 hours post dose	No
Secondary	Apparent Volume of Distribution (Vz/F) for PF-06409577	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, 8, 12, 16, 24, 36, 48 hours post dose	No
Secondary	Total amount of PF-06409577 excreted in the urine over 24 hours (Ae24)	Total amount of unchanged drug excreted in the urine over 24 hours.	0-24 hours post dose	No
Secondary	Total amount of PF-06409577 excreted in the urine over 24 hours, expressed as percent of dose (%Ae24)	Total amount of unchanged drug excreted in the urine over 24 hours, expressed as percent of dose.	0-24 hours post dose	No
Secondary	Renal clearance for PF-06409577	Renal clearance of a drug is a measure of the rate at which a drug is excreted unchanged into urine.	0-24 hours post dose	No