Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| FIH | Other Identifier | Alias Study Number | |
| 2014-004022-18 | EudraCT Number |
Not provided
Not provided
Not provided
The trial was terminated prematurely on June 19, 2015 for business reasons. There were no safety concerns in the study which led to the decision.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: PF-06409577 or placebo | Experimental | Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK. |
|
| Cohort 2: PF-06409577 or placebo | Experimental | Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK. |
|
| Cohort 3: PF-06409577 or placebo | Experimental | Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK. |
|
| Cohort 4: PF-06409577 or placebo | Experimental | Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK. |
|
| Cohort 5: PF-06409577 or placebo | Experimental | Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK. |
|
| Cohort 6: PF-06409577 or placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06409577 or Placebo | Drug | PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06409577 |
Not provided
Inclusion Criteria:
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)
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit | Brussels | B-1070 | Belgium |
Not provided
| ID | Term |
|---|---|
| C000617640 | PF-6409577 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Experimental |
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK. |
|
| Cohort 7: PF-06409577 or placebo | Experimental | Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK. |
|
| Cohort 8: PF-06409577 or placebo | Experimental | Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK. |
|
| Cohort 9: PF-06409577 or placebo | Experimental | Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK. |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |