An Investigator And Subject-blind Phase 1 Study To Characterize The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Doses Of Pf-03382792 In Healthy Elderly Subjects
Overview
- Phase
- Phase 1
- Intervention
- PF-03382792 0.5mg
- Conditions
- Healthy
- Sponsor
- Pfizer
- Primary Endpoint
- Safety Endpoints include: AEs, vital signs, triplicate ECGs,
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
Brief Summary
This study is designed to look at the safety and blood concentrations of PF-03382792 in healthy elderly subjects after taking multiple doses for 14 days.
Detailed Description
To examine safety, toleratibilty and pharmacokinetics of PF-03382792 in healthy elderly subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy volunteer aged 65-80 years old
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
- •Total body weight \>50 kg (110 lbs).
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).
- •Subjects with symptoms or signs of adrenal insufficiency.
- •Subjects with clinically significant ocular lens abnormalities as detected by the investigator based on the findings of a slit lamp examination performed by an ophthalmologist.
Arms & Interventions
Dosing
Ascending Doses
Intervention: PF-03382792 0.5mg
Dosing
Ascending Doses
Intervention: PF-03382792 1.5 mg
Dosing
Ascending Doses
Intervention: PF-03382792 5 mg
Dosing
Ascending Doses
Intervention: PF-03382792 15 mg
Outcomes
Primary Outcomes
Safety Endpoints include: AEs, vital signs, triplicate ECGs,
Time Frame: Day 0 to Day 28
Safety Endpoints include: Cosyntropin Stimulation Test, Clinical Examinations, Slit Lamp Examination, Aldosterone Concentrations
Time Frame: Day 0 to Day 28
Pharmacokinetic endpoints include: Plasma concentrations of PF 03382792 and its N dealkylated metabolite, PF 03227077, will be measured and used to determine Cmax, Tmax, AUC on Day 1 and Css,max, Tss,max, AUC, Css,min, Css,avg on Days 7 and 14.
Time Frame: Day 0 to Day 28
Additional pharmacokinetic endpoints: the accumulation ratio (Rac) will be determined from Day 14 and Day 1 AUC. If data permit, t1/2 and urinary excretion parameters (CLR for the parent and Ae and Ae%) will be calculated.
Time Frame: Day 0 to Day 28
Safety Endpoints include: safety laboratory endpoints (including a complete blood count and a full chemistry panel, including electrolytes, hepatic transaminases, and urinalysis, with microscopic analysis if dipstick analysis is positive),
Time Frame: Day 0 to Day 28