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OpenTrials
Completed

NCT Number: NCT01186757

Multiple Dose Healthy Volunteer Study of PF-03715455.

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

Completed

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Key information

Conditions

Healthy Volunteers

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Singapore, 188770

About this study

Healthy volunteer PK study

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers

Exclusion criteria

  • Standard healthy volunteer criteria

Treatment and study plan

PF-03715455

Drug

PF-03715455 1.6 mg BID

Placebo

Drug

Placebo

Primary outcomes

  1. 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).

    Time frame: 17 days

Secondary outcomes

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

    Time frame: 28 Days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Acronym: MD-MULTI DOSE

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 23, 2010
Registry last updated
Jan 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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