A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04629991 in Healthy Volunteers

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00797342
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Arms: 3
• Duration (Months): 4
• Patients Per Site Per Month: 6.8

Study Details

Study Description

Brief Summary

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04629991 in healthy subjects. Dose exploration will proceed in a step-wise manner, beginning with low doses not expected to have significant biological effects and proceeding to doses approximating or exceeding the anticipated therapeutic level. Doses to be explored may be limited by tolerability, and will not exceed levels previously shown to be tolerable in animals.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: PF-04629991; Drug: PF-04629991; Drug: PF-04629991	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Official Title: A Phase 1, Randomized, Double Blind (Sponsor Open), Placebo Controlled, Single-Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effect of PF-04629991 in Healthy Volunteers
• Study Start Date: Dec 1, 2008
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: first of three dosing cohorts	Drug: PF-04629991; Oral; Sequential single dose escalation; three fourteen-day treatment periods per subject in the first cohort; randomized sequence of treatments (one placebo and two PF-04629991 doses)
Other: second of three dosing cohorts	Drug: PF-04629991; Oral; Sequential single dose escalation; three fourteen-day treatment periods per subject in the second cohort; randomized sequence of treatments (one placebo and two PF-04629991 doses)
Other: third of three dosing cohorts	Drug: PF-04629991; Oral; sequential single dose escalation; three fourteen-day treatment periods per subject in the third cohort; randomized assignment to treatment (placebo or PF-04629991)

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics e.g., maximum concentration and area under the concentration-time curve [2 weeks]

2. Safety/Tolerability e.g., reported adverse events and safety laboratory studies [2 weeks]

3. Pharmacodynamics e.g., changes in a peripheral blood biomarker [2 weeks]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Healthy non-smoking men and women

• body mass index 18-30 kg/m2

Exclusion Criteria:

• Women must not be able to have children

• no current infections

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Bruxelles		Belgium	1070

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: NCT00797342
• Other Study ID Numbers: B0881001
• First Posted: Nov 25, 2008
• Last Update Posted: May 5, 2009
• Last Verified: May 1, 2009

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Study Results

No Results Posted as of May 5, 2009