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)

Healthy Clinical Trial

Official title:

A Phase 1 Double Blind (3rd Party Open) Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Safety, Tolerability And Pharmacokinetics Of Repeat Doses Of Pf-06372865 In Subjects Aged 18-55 (Group 1) And 56-75 Years (Group 2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02070289
• Other study ID #: B7431002
• Status: Completed
• Phase: Phase 1
• First received: February 20, 2014
• Last updated: August 15, 2014
• Start date: March 2014
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-06372865
Tablets, 2.5 mg BID, 14 days
• Placebo
Tablets, BID, 14 days
• PF-06372865
Tablets, to be decided dose, BID or titration, 14 days
• Placebo
Tablets, BID or titration, 14 days
• PF-06372865
Tablets, to be decided dose, BID or titration, 14 days
• Placebo
Tablets, BID or titration, 14 days
• PF-06372865
Tablets, to be decided dose, BID or titration, 14 days
• Placebo
Tablets, BID or titration, 14 days
• PF-06372865
Tablets, to be decided dose, BID or titration, 14 days
• Placebo
Tablets, BID or titration, 14 days
• PF-06372865
Tablets, to be decided dose, BID or titration, 14 days

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)		14 days	No
Primary	Area Under the Curve from Time Zero to end of dosing interval (AUCtau)		14 days	No
Primary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		14 days	No

External Links

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