Multiple Oral Doses Of PH-797804 In Healthy Japanese Adult Subjects

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01217918
• Collaborator: (none)
• Enrollment: 30
• Locations: 2
• Arms: 3
• Duration (Months): 4
• Patients Per Site: 15
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief Summary

Study A6631027 will evaluate the safety, tolerability and pharmacokinetics of PH-797804 when administered to healthy Japanese subjects once a day (QD) for 10 days.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: 1 mg; Drug: 5 mg; Drug: 10 mg	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: APhase 1, Placebo-Controlled, Randomized, Parallel Group, Subject- And Investigator-Blind, Sponsor-Open Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PH-797804 Following Multiple Escalating Oral Doses In Healthy Japanese Adult Subjects
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 PH-797804	Drug: 1 mg; 1 mg or placebo a material sparing tablet per day for 10 days
Experimental: Cohort 2 PH-797804	Drug: 5 mg; 5 mg or placebo as material sparing tablet per day for 10 days
Experimental: Cohotr 3 PH-797804	Drug: 10 mg; 10 mg or placebo as a material sparing tablet per day for 10 days

Outcome Measures

Primary Outcome Measures

1. Incidence and severity of adverse events; of clinical findings on physical examination; and of clinical laboratory abnormalities. [Day 1 to Follow-up]

2. Mean change from baseline in vital signs (blood pressure and heart rate) measurements [Baseline to Follow-up]

3. Mean change from baseline in 12-lead ECG parameters [Baseline to Follow-up]

4. Plasma PH-797804 Cmax, Cmin, Cavg(ss), Tmax, AUC(0-last), AUC(0-inf), AUC(0-tau), t1/2, CL/F, Vz/F, Rac, and Rac, Cmax [Days 1 and 10]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy Volunteers

• Japanese

Exclusion Criteria:

• Subjects with clinically significant skin lesions

• Subjects with known tuberculosis infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Culver City	California	United States	90232
2	Pfizer Investigational Site	Glendale	California	United States	91206

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: NCT01217918
• Other Study ID Numbers: A6631027
• First Posted: Oct 8, 2010
• Last Update Posted: Feb 15, 2011
• Last Verified: Feb 1, 2011

• Keywords provided by , ,: PH-797804; Japanese; Phase 1; multiple dose study

Study Results

No Results Posted as of Feb 15, 2011