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Multiple Dose Healthy Volunteer Study of PF-03715455.

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01186757
Acronym
MD-MULTI DOSE
Enrollment
36
Registered
2010-08-23
Start date
2010-08-31
Completion date
2011-01-31
Last updated
2011-01-12

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

Conditions

Healthy Volunteers

Brief summary

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

Detailed description

Healthy volunteer PK study

Interventions

DRUGPF-03715455

PF-03715455 1.6 mg BID

DRUGPlacebo

Placebo

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy volunteers

Exclusion criteria

* Standard healthy volunteer criteria

Design outcomes

Primary

MeasureTime frame
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

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

Countries

Singapore

Outcome results

None listed

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