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Clinical Trials/NCT00990015
NCT00990015
Completed
Phase 1

A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, Single-Dose Escalation Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04308515 in Healthy Volunteers

Pfizer1 site in 1 country27 target enrollmentOctober 2009
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ConditionsHealthy Volunteers
InterventionsPF-04308515Placebo
DrugsPF-04308515Placebo

Overview

Phase
Phase 1
Intervention
PF-04308515
Conditions
Healthy Volunteers
Sponsor
Pfizer
Enrollment
27
Locations
1
Primary Endpoint
To evaluate the safety, tolerability and pharmacokinetics (PK) of single-rising doses of PF-04308515
Status
Completed
Last Updated
16 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics (understanding how a drug is absorbed and moves through the body) and pharmacodynamics (understanding the effects of a drug on certain target sites of activity in the body).

Registry
clinicaltrials.gov
Start Date
October 2009
End Date
January 2010
Last Updated
16 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Pfizer

Eligibility Criteria

Inclusion Criteria

  • •Healthy males between 18 and 55 years, inclusive
  • •Healthy females between 18 and 44 years, inclusive.
  • •Women need to be surgically sterile

Exclusion Criteria

  • •Evidence or history of clinically significant disease
  • •Post-menopausal women
  • •History of intolerance or significant adverse effects with glucocorticoids

Arms & Interventions

PF-04308515

Intervention: PF-04308515

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

To evaluate the safety, tolerability and pharmacokinetics (PK) of single-rising doses of PF-04308515

Time Frame: 1 day

To characterize the pharmacodynamic (PD) effects of PF-04308515 on biomarkers

Time Frame: 1 day

Study Sites (1)

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