A Study To Look At Safety And Blood Concentrations After Multiple Doses Of PF-03382792 In Healthy Elderly Individuals

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01089738
• Other study ID #: B1651003
• Status: Withdrawn
• Phase: Phase 1
• Start date: November 1, 2010
• Est. completion date: April 25, 2011

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

To examine safety, toleratibilty and pharmacokinetics of PF-03382792 in healthy elderly subjects.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 25, 2011
• Est. primary completion date: April 25, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-03382792 0.5mg
0.5 mg PF-03382792, qd, for 14 days or placebo
• PF-03382792 1.5 mg
1.5 mg PF-03382792, qd, for 14 days or placebo
• PF-03382792 5 mg
5 mg PF-03382792, qd, for 14 days or placebo
• PF-03382792 15 mg
15 mg PF-03382792, qd, for 14 days or placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Endpoints include: AEs, vital signs, triplicate ECGs,		Day 0 to Day 28
Primary	Safety Endpoints include: Cosyntropin Stimulation Test, Clinical Examinations, Slit Lamp Examination, Aldosterone Concentrations		Day 0 to Day 28
Primary	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),		Day 0 to Day 28
Primary	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.		Day 0 to Day 28
Primary	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.		Day 0 to Day 28

External Links

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