A Study In Healthy Elderly People To Evaluate Safety, Toleration, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses Of PF-06743649

Healthy Elderly Clinical Trial

Official title:

A Phase 1 Double Blind (3rd Party Open) Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Repeat Doses Of Pf-06743649 In Healthy Elderly Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02170012
• Other study ID #: B7911004
• Status: Terminated
• Phase: Phase 1
• First received: June 19, 2014
• Last updated: March 16, 2015
• Start date: July 2014
• Est. completion date: September 2014

Study information

• Verified date: March 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study in healthy elderly people is to evaluate safety, toleration and time course of plasma concentration of multiple oral doses of PF-06743649- The pharmacodynamic activity of PF-06743649 will also be assessed.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

• Healthy male and/or female subjects between the ages of 65 and 85 years, inclusive. Ideally at least 25% of the subjects enrolled in each cohort will be 75 years of age and above at Screening. Subjects must be healthy 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 test results. Subjects with mild, chronic, stable disease and on stable medication may be enrolled if deemed medically prudent by the investigator.

• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

• 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 time of dosing).

• Any condition possibly affecting drug absorption (eg, gastrectomy).

• Evidence of gout/hyperuricemia, measured sUA >8 mg/dL at screening.

• Experienced an episode of nephrolithiasis or ureterolithiasis.

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 Elderly

Intervention

Drug:
• PF-06743649
20 mg tablet once daily dosing for 14 days
• Placebo
Placebo tablet once daily dosing for 14 days
• PF-06743649
To be decided dose, tablet once daily dosing for 14 days
• Placebo
Placebo tablet once daily dosing for 14 days
• PF-06743649
To be decided dose, tablet once daily dosing for 14 days
• Placebo
Placebo tablet once daily dosing for 14 days
• PF-06743649
To be decided dose, tablet once daily dosing for 14 days
• Placebo
Placebo tablet once daily dosing for 14 days
• PF-06743649
To be decided dose, tablet once daily dosing for 14 days
• Placebo
Placebo tablet once daily dosing for 14 days

Locations

Country	Name	City	State
United States	Miami Research Associates, Inc.	South Miami	Florida
United States	MRA Clinical Research, LLC	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)		up to 14 days	No
Primary	Area Under the Curve from Time Zero to end of dosing interval (AUCtau)		up to 14 days	No
Primary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		up to 14 days	No
Primary	Plasma Decay Half-Life (t1/2)		up to 14 days	No
Primary	Amount of drug recovered unchanged in urine during the dosing interval (Aetau)		up to 14 days	No
Primary	Percent of dose recovered unchanged in urine during the dosing interval(Aetau%)		up to 14 days	No
Primary	Renal clearance (CLr)		up to 14 days	No
Secondary	Change from baseline in serum uric acid level		up to 14 days	No
Secondary	Change from baseline in serum levels of xanthine and hypoxanthine		up to 14 days	No
Secondary	Urinary uric acid levels		up to 14 days	No
Secondary	Urinary xanthine levels		up to 14 days	No
Secondary	Urinary hypoxanthine levels		up to 14 days	No

External Links

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