A Study to Evaluate Safety, Toleration and Time Course of Plasma Concentration of Multiple Oral Doses of PF-06372865 in Healthy Subjects of Two AgeGroups, Aged 18-55 Years (Group 1) and Aged 56-75 Years (Group 2)

NCT02070289 | Completed Phase 1

• 1 other identifier: B7431002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate safety, toleration and time course of plasma concentration of multiple oral doses of PF-06372865 for 14 days in healthy subjects of two age groups, 18-55 years (Group 1) and 56-75 years (Group 2).

Conditions

Healthy

Keywords

Multiple dose; safety; tolerability; PK

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax)

  14 days

• Area Under the Curve from Time Zero to end of dosing interval (AUCtau)

  14 days

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  14 days

Study Arms (6)

Group 1: Cohort 1

EXPERIMENTAL

Drug: PF-06372865; Drug: Placebo

Group 1: Cohort 2

EXPERIMENTAL

Drug: PF-06372865; Drug: Placebo

Group 1: Cohort 3

EXPERIMENTAL

Drug: PF-06372865; Drug: Placebo

Group 2: Cohort 4

EXPERIMENTAL

Drug: PF-06372865; Drug: Placebo

Group 1 or 2: Cohort 5

EXPERIMENTAL

Drug: PF-06372865; Drug: Placebo

Group 1 or 2: Cohort 6

EXPERIMENTAL

Drug: PF-06372865

Interventions

PF-06372865 DRUG

Tablets, 2.5 mg BID, 14 days

Group 1: Cohort 1

Placebo DRUG

Tablets, BID, 14 days

Group 1: Cohort 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For Group 1 specific: Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive at Screening. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory.
• For Group 2 specific: Male and/or female subjects of non-childbearing potential between the ages of 56 and 75 years, inclusive at Screening. Subjects must be in reasonably good health as determined by the Investigator based on a detailed medical history, full physical examination (including blood pressure and pulse rate measurement), 12-lead ECG and clinical laboratory tests. Subjects with mild, chronic, stable disease (eg, osteoarthritis) may be enrolled if deemed medically prudent by the Investigator. At least 50% of the subjects enrolled in these cohorts must be 60 years of age and above at Screening.
• For Group 2 specific: Subjects taking daily prescription or non-prescription medications for management of acceptable chronic medical conditions must be on a stable dose of these, as defined by non change in dose for the 3 months prior to the first dose of study medication and no planned changes during the conduct of the study.

You may not qualify if:

• For Group 1 specific: 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).
• For Group 2 specific : Evidence or history of unstable disease or moderate to severe conditions which would, in the Investigator's opinion, interfere with the study evaluations or impact on the safety of participating subjects, such as orthostatic hypotension.
• Subjects with history of sleep apnea
• Any condition possibly affecting drug absorption (eg, gastrectomy).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Brussels, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

PF-06372865

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: February 25, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 18, 2014

Record last verified: 2014-08

Locations

BE (1)