A Phase 1 Single-Dose Escalation Study of PF-04308515 in Healthy Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00990015

Enrollment

Registered

2009-10-06

Start date

2009-10-31

Completion date

2010-01-31

Last updated

2010-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Safety; tolerability; pharmacokinetics/pharmacodynamics

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).

Interventions

DRUGPF-04308515

Oral solution/suspension 0.1 mg up to potentially 350 mg QD at a single dose.

DRUGPlacebo

Placebo solution/suspension to match active drug QD at a single dose.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
To evaluate the safety, tolerability and pharmacokinetics (PK) of single-rising doses of PF-04308515	1 day
To characterize the pharmacodynamic (PD) effects of PF-04308515 on biomarkers	1 day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026