First-In-Human Study Of Single And Multiple Ascending Doses Of PF-06751979

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Placebo multiple dose; Drug: PF-06751979 multiple ascending dose; Drug: Placebo single dose; Drug: PF-06751979 single ascending dose; Drug: PF-06751979 multiple dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02509117

B8271001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, PK and PD of PF-06751979 following oral doses in healthy adult and healthy elderly subjects.

Enrollment: 55 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years or between the ages of 60 and 85 years, inclusive.
• Body Mass Index (BMI) of 17.5 to 32 kg/m2; and a total body weight >50 kg (110 lbs) at Screening.
• Evidence of a personally signed and dated informed consent document indicating that the subject or a legally acceptable representative has been informed of all pertinent aspects of the study.

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 the time of dosing).
• Male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
• Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
• Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.
• Any severe acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.

Trial design

55 participants in 5 patient groups, including a placebo group

Single Ascending Dose Cross-over

Experimental group

Description:

Single Ascending Dose in 4-way cross-over design (PF-06751979/Placebo).

Treatment:

Drug: PF-06751979 single ascending dose

Drug: Placebo single dose

Multiple Ascending Dose PF-06751979

Experimental group

Description:

Multiple dose administration to Healthy Subjects in parallel cohorts(PF-06751979)

Treatment:

Drug: PF-06751979 multiple ascending dose

Multiple Ascending Dose Placebo

Placebo Comparator group

Description:

Multiple dose administration to Healthy Subjects in parallel cohorts(Placebo)

Treatment:

Drug: Placebo multiple dose

Drug: PF-06751979 multiple dose

Drug: PF-06751979 multiple dose

Multiple Dose Elderly PF-06751979

Experimental group

Description:

Multiple dose administration to Healthy Elderly Subjects (PF-06751979)

Treatment:

Drug: PF-06751979 multiple dose

Drug: PF-06751979 multiple dose

Multiple Dose Elderly Placebo

Placebo Comparator group

Description:

Multiple dose administration to Healthy Elderly Subjects (Placebo)

Treatment:

Drug: Placebo multiple dose