MD-MULTI DOSE: Multiple Dose Healthy Volunteer Study of PF-03715455.

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01186757
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 4
• Duration (Months): 5
• Patients Per Site Per Month: 7.2

Study Details

Study Description

Brief Summary

Evaluation of the multiple dose pharmacokinetics of PF-3715455 in healthy volunteers

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: PF-03715455; Drug: PF-03715455; Drug: PF-03715455; Drug: Placebo	Phase 1

Detailed Description

Healthy volunteer PK study

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Official Title: A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Multiple Inhaled Doses Of PF-03715455 In Healthy Subjects
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PF-03715455 1.6mg BID	Drug: PF-03715455; PF-03715455 1.6 mg BID
Active Comparator: PF-03715455 4 mg BID	Drug: PF-03715455; PF-03715455 4mg BID
Active Comparator: PF-03715455 10 mg BID	Drug: PF-03715455; PF-03715455 10 mg BID
Placebo Comparator: Placebo	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics of single and multiple inhaled doses of PF-03715455, as measured by plasma concentrations - Cmax, Tmax, AUCtau, t½, accumulation ratio (Rac, Rss, Rac,Cmax). [17 days]

Secondary Outcome Measures

1. Safety and toleration as measured by adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination. [28 Days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy volunteers

Exclusion Criteria:

• Standard healthy volunteer criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Singapore		Singapore	188770

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01186757
• Other Study ID Numbers: A9111002
• First Posted: Aug 23, 2010
• Last Update Posted: Jan 12, 2011
• Last Verified: Jan 1, 2011

Study Results

No Results Posted as of Jan 12, 2011