Healthy
Conditions
Keywords
Single Ascending Dose, healthy subjects
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.
Interventions
DRUGPF-06409577 or Placebo
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events (AEs) | 0-48 hours post dose |
| Number of Participants With Laboratory Test Values of Potential Clinical Importance | 0-48 hours post dose |
| Number of Participants With Vital Signs Findings (Including Bood Pressure and Pulse Rate) of Potential Clinical Importance | 0-48 hours post dose |
| Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | 0-48 hours post dose |
| Number of Participants With Echocardiogram Findings of Potential Clinical Importance | 0-48 hours post dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Decay Half-Life (t1/2) for PF-06409577 | 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose | Plasma Decay Half-Life (t1/2) |
| Apparent Oral Clearance (CL/F) for PF-06409577 | 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose | 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. |
| Apparent Volume of Distribution (Vz/F) for PF-06409577 | 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose | 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. |
| Maximum Observed Plasma Concentration (Cmax) for PF-06409577 | 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose | Maximum Observed Plasma Concentration (Cmax) |
| Total amount of PF-06409577 excreted in the urine over 24 hours, expressed as percent of dose (%Ae24) | 0-24 hours post dose | Total amount of unchanged drug excreted in the urine over 24 hours, expressed as percent of dose. |
| Renal clearance for PF-06409577 | 0-24 hours post dose | Renal clearance of a drug is a measure of the rate at which a drug is excreted unchanged into urine. |
| Total amount of PF-06409577 excreted in the urine over 24 hours (Ae24) | 0-24 hours post dose | Total amount of unchanged drug excreted in the urine over 24 hours. |
| Area Under the Curve From Time Zero to Time 24 hours (AUC24) for PF-06409577 | 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose | Area under the plasma concentration time-curve from zero to time 24 hours post dose (AUC24) |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06409577 | 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] for PF-06409577 | 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose | 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). |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06409577 | 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose | Time to Reach Maximum Observed Plasma Concentration (Tmax) |
Countries
Belgium
Outcome results
None listed