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

NCT01089738 | Withdrawn Phase 1

• 1 other identifier: B1651003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

mulitple dose; pharmacokinetics; safety; healthy elderly volunteers

Outcome Measures

Primary Outcomes (5)

• Safety Endpoints include: AEs, vital signs, triplicate ECGs,

  Day 0 to Day 28

• Safety Endpoints include: Cosyntropin Stimulation Test, Clinical Examinations, Slit Lamp Examination, Aldosterone Concentrations

  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),

  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.

  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.

  Day 0 to Day 28

Study Arms (1)

Dosing

EXPERIMENTAL

Ascending Doses

Drug: PF-03382792 0.5mg; Drug: PF-03382792 1.5 mg; Drug: PF-03382792 5 mg; Drug: PF-03382792 15 mg

Interventions

PF-03382792 0.5mg DRUG

0.5 mg PF-03382792, qd, for 14 days or placebo

Dosing

PF-03382792 15 mg DRUG

15 mg PF-03382792, qd, for 14 days or placebo

Dosing

PF-03382792 5 mg DRUG

5 mg PF-03382792, qd, for 14 days or placebo

Dosing

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

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).
• 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.

Sponsors & Collaborators

• Pfizer: lead

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
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 18, 2010
• Study Start: November 1, 2010
• Primary Completion: April 25, 2011
• Study Completion: April 25, 2011
• Last Updated: November 6, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share