Trial record 2 of 2 for:
PF-03049423
A Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03049423 In Healthy Adult Volunteers And Healthy Older Volunteers
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01161069
First received: May 7, 2010
Last updated: August 8, 2011
Last verified: August 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: PF-03049423 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Parallel Group, Multiple Dose Escalation Study To Evaluate The Safety, Toleration, Pharmacokinetics Of PF-03049423 In Healthy Young Adult Volunteers And Healthy Elderly Volunteers |
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Safety laboratory assessments, vital signs (including supine and standing blood pressure), physical examination, 12-lead ECGs and adverse events. [ Time Frame: Days 1 through 14 ] [ Designated as safety issue: Yes ]
- PK Parameters:Day 1: Area under concentration time curve from hour 0 to the last dosing interval (AUCtau), maximum observed concentration (Cmax), and time of maximum observed concentration (Tmax), for PF-03049423 in plasma. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
- PK Parameters: Day 14: Cmax at steady state, Tmax, AUCtau at steady state , t½, Cavg at steady state, Cmin at steady state, Cmax at steady state /Cmax sd, AUCtau at steady state/ AUCtau sd, Ae% and CLr. [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Blood pressure [ Time Frame: Days 1 to 14 ] [ Designated as safety issue: Yes ]
| Enrollment: | 48 |
| Study Start Date: | August 2009 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: PF-03049423
Cohorts 1 through 3 were healthy young adult volunteers; cohorts 4 and 5 were healthy elderly adult volunteers
|
Drug: PF-03049423
PF-03049423 in oral solution, 2.5 mg, given once daily for 14 days; healthy young adult volunteers
Drug: PF-03049423
PF-03049423 in oral solution, 7.5 mg, given once daily for 14 days; healthy young adult volunteers
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
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
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
|
|
Placebo Comparator: Drug
Placebo in oral solution, given once daily for 14 days
|
Drug: Placebo
Placebo in oral solution, given once daily for 14 days
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT01161069 History of Changes |
| Other Study ID Numbers: | A9541002 |
| Study First Received: | May 7, 2010 |
| Last Updated: | August 8, 2011 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by Pfizer:
|
phase 1 healthy young adult volunteers healthy elderly adult volunteers |
ClinicalTrials.gov processed this record on May 16, 2013