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

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: PF-06409577 or Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02286882

FIH (Other Identifier)

B7881001

2014-004022-18 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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39 participants in 9 patient groups

Cohort 1: PF-06409577 or placebo

Experimental group

Description:

Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.

Treatment:

Drug: PF-06409577 or Placebo

Cohort 2: PF-06409577 or placebo

Experimental group

Description:

Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.

Treatment:

Drug: PF-06409577 or Placebo

Cohort 3: PF-06409577 or placebo

Experimental group

Description:

Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.

Treatment:

Drug: PF-06409577 or Placebo

Cohort 4: PF-06409577 or placebo

Experimental group

Description:

Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.

Treatment:

Drug: PF-06409577 or Placebo

Cohort 5: PF-06409577 or placebo

Experimental group

Description:

Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.

Treatment:

Drug: PF-06409577 or Placebo

Cohort 6: PF-06409577 or placebo

Experimental group

Description:

Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.

Treatment:

Drug: PF-06409577 or Placebo

Cohort 7: PF-06409577 or placebo

Experimental group

Description:

Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.

Treatment:

Drug: PF-06409577 or Placebo

Cohort 8: PF-06409577 or placebo

Experimental group

Description:

Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.

Treatment:

Drug: PF-06409577 or Placebo

Cohort 9: PF-06409577 or placebo

Experimental group

Description:

Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.

Treatment:

Drug: PF-06409577 or Placebo