A Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03049423 In Healthy Adult Volunteers And Healthy Older Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose this study is to evaluate the safety and toleration of PF-03049423 following multiple dose administration as an oral solution to healthy young adult volunteers and healthy elderly volunteers. The study will also evaluate the pharmacokinetics of PF-03049423 after multiple dose administration to healthy young adult volunteers and healthy elderly volunteers. The study will also explore the relationship between blood pressure (supine and standing) and PF-03049423 concentration.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study In Healthy Adult Volunteers To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429

NCT01117233

Healthy

COMPLETED PHASE1

A Clinical Study Evaluating The Safety And Tolerability Of PF-04427429 In Healthy Adult Volunteers. The Pharmacokinetics And Pharmacodynamics Of PF-04427429 Will Also Be Investigated

NCT01165723

Healthy

COMPLETED PHASE1

Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects

NCT01012310

Healthy Volunteers

COMPLETED PHASE1

A Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Volunteers

NCT01897142

Healthy

COMPLETED PHASE1

A Study to Learn How the Study Medicine PF-07899895 Are Tolerated and Act in the Body of Healthy Adults

NCT06137729

Healthy

TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of the investigation is to evaluate the safety and tolerability of an investigational new drug, PF-03049423, when dosed for two weeks in both healthy younger and healthy older subjects.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PF-03049423

Cohorts 1 through 3 were healthy young adult volunteers; cohorts 4 and 5 were healthy elderly adult volunteers

Group Type ACTIVE_COMPARATOR

PF-03049423

Intervention Type DRUG

PF-03049423 in oral solution, 2.5 mg, given once daily for 14 days; healthy young adult volunteers

PF-03049423

Intervention Type DRUG

PF-03049423 in oral solution, 7.5 mg, given once daily for 14 days; healthy young adult volunteers

PF-03049423

Intervention Type DRUG

PF-03049423 in oral solution, 6 mg, given once daily for 7 days, then 12 mg given once daily for 7 days; healthy young adult volunteers

PF-03049423

Intervention Type DRUG

PF-03049423 in oral solution, 3 mg, given once daily for 7 days, then 6 mg given once daily for 7 days; healthy elderly adult volunteers

PF-03049423

Intervention Type DRUG

PF-03049423 in oral solution, 5 mg, given once daily for 7 days, then 10 mg given once daily for 7 days; healthy elderly adult volunteers

Drug

Placebo in oral solution, given once daily for 14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo in oral solution, given once daily for 14 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PF-03049423

PF-03049423 in oral solution, 2.5 mg, given once daily for 14 days; healthy young adult volunteers

Intervention Type DRUG

PF-03049423

PF-03049423 in oral solution, 7.5 mg, given once daily for 14 days; healthy young adult volunteers

Intervention Type DRUG

PF-03049423

PF-03049423 in oral solution, 6 mg, given once daily for 7 days, then 12 mg given once daily for 7 days; healthy young adult volunteers

Intervention Type DRUG

PF-03049423

PF-03049423 in oral solution, 3 mg, given once daily for 7 days, then 6 mg given once daily for 7 days; healthy elderly adult volunteers

Intervention Type DRUG

PF-03049423

PF-03049423 in oral solution, 5 mg, given once daily for 7 days, then 10 mg given once daily for 7 days; healthy elderly adult volunteers

Intervention Type DRUG

Placebo

Placebo in oral solution, given once daily for 14 days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy persons, male or female.
* For the healthy young adult cohort, subjects must be 18 to 50 years old, inclusive.
* For the healthy elderly adult cohort, subjects must be 51 to 99 years old, inclusive.
* Body Mass Index (BMI) of 18 to 35; and a total body weight \>50 kg (110 lbs)

Exclusion Criteria

* Subjects with clinically significant medical conditions.
* Women of non-child bearing potential.
* Subjects with a known medical history of hearing loss/disability or nonarteritic ischemic optic neuropathy.
* A positive urine drug screen.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes