A Study To Observe Safety And Blood Concentrations Of PF-04995274 During And Following the Administration of Multiple Doses Of PF-04995274 In Healthy Adult And Healthy Elderly Volunteers.

NCT01169714 | Completed Phase 1

• 1 other identifier: B1661003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

This study is designed to observe the safety and blood concentrations of PF-04995274 during and following the administration of multiple doses of PF-04995274 for a duration of 14 days, in healthy adult and healthy elderly.

Conditions

Healthy

Keywords

multiple dose; healthy volunteer; healthy elderly volunteer; safety; pharmacokinetic

Outcome Measures

Primary Outcomes (3)

• Safety Endpoints (Adverse events, Change from baseline in vital signs, Change from baseline in triplicate ECGs, Clinical safety laboratory, Clinical examinations, Digit Symbol Substitution Test (DSST))

  Day 0 to Day 28

• Pharmacokinetic endpoints Plasma concentration of PF 04995274 over time (eg, AUC, Cmax, Tmax, t1/2), Plasma concentration of PF 05082547 over time (eg, AUC, Cmax, Tmax, t1/2).

  Day 0 to Day 28

• Pharmacodynamic endpoint Aldosterone concentration in healthy adult subjects.

  Day 0 to Day 14

Secondary Outcomes (1)

• No secondary outcomes

Study Arms (2)

Dosing Healthy Adult

EXPERIMENTAL

Ascending Doses in Healthy Adult Volunteers

Drug: 0.1 mg PF-04995274; Drug: 1 mg PF-04995274; Drug: 10 mg PF-04995274; Drug: 15 mg PF-04995274

Dosing Healthy Elderly

EXPERIMENTAL

Dosing in Healthy Elderly volunteers

Drug: 1.0 mg PF-04995274; Drug: 15 mg PF-04995274

Interventions

0.1 mg PF-04995274 DRUG

0.1 mg PF-04995274, qd, for 14 days or placebo

Dosing Healthy Adult

1 mg PF-04995274 DRUG

1 mg PF-04995274, qd, for 14 days or placebo

Dosing Healthy Adult

1.0 mg PF-04995274 DRUG

1.0 mg PF-04995274, qd, for 14 days or placebo

Dosing Healthy Elderly

15 mg PF-04995274 DRUG

15 mg PF-04995274, qd, for 14 days or placebo

Dosing Healthy Adult

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For Healthy adult volunteers: healthy male and/or female subjects of non child bearing potential between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests.)
• For Healthy Elderly volunteers: healthy male and/or female subjects of non child bearing potential between the ages of 65 and 85 years, inclusive. 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, controlled hypertension, non-insulin dependent diabetes, osteoarthritis) may be enrolled if deemed medically prudent by the investigator. In order to ensure an age range relevant to the Alzheimer's Disease (AD) population, no more than 30% of subjects enrolled in any cohort may be less than 70 years of age.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Pfizer Investigational Site

Overland Park, Kansas, 66211, United States

Location

Pfizer Investigational Site

Overland Park, Kansas, 66212, United States

Location

Related Links

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

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
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: July 26, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 20, 2011

Record last verified: 2011-01

Locations

US (2)