Clinical trial NCT02286882: A Single Oral Dose Study Of PF-06409577 In Healthy Adult Subjects
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: Single Ascending Dose
healthy subjects
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-11-10
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: 0-48 hours post dose
measure: Number of Participants With Laboratory Test Values of Potential Clinical Importance
timeFrame: 0-48 hours post dose
measure: Number of Participants With Vital Signs Findings (Including Bood Pressure and Pulse Rate) of Potential Clinical Importance
timeFrame: 0-48 hours post dose
measure: Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance
timeFrame: 0-48 hours post dose
measure: Number of Participants With Echocardiogram Findings of Potential Clinical Importance
timeFrame: 0-48 hours post dose
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Time 24 hours (AUC24) for PF-06409577
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06409577
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] for PF-06409577
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
measure: Maximum Observed Plasma Concentration (Cmax) for PF-06409577
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06409577
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
measure: Plasma Decay Half-Life (t1/2) for PF-06409577
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
measure: Apparent Oral Clearance (CL/F) for PF-06409577
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
measure: Apparent Volume of Distribution (Vz/F) for PF-06409577
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
measure: Total amount of PF-06409577 excreted in the urine over 24 hours (Ae24)
timeFrame: 0-24 hours post dose
measure: Total amount of PF-06409577 excreted in the urine over 24 hours, expressed as percent of dose (%Ae24)
timeFrame: 0-24 hours post dose
measure: Renal clearance for PF-06409577
timeFrame: 0-24 hours post dose
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: