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Completed

NCT Number: NCT01753791

Study To Evaluate Safety, Tolerability, And Pharmacokinetics Of PF-06473871 In Normal Healthy Adults

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of PF-06473871 in normal healthy adults.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male and/or females between the ages of 18 and 55 years inclusive

Exclusion criteria

  • Currently pregnant

Treatment and study plan

80 mg PF-06473871

Drug

80 mg of PF-06473871 or placebo

160 mg PF-06473871

Drug

160 mg of PF-06473871 or placebo

320 mg PF-06473871

Drug

320 mg of PF-06473871 or placebo

480 mg PF-06473871

Drug

480 mg of PF-06473871 or placebo

Primary outcomes

  1. Incidence of Adverse events

    Time frame: 6 weeks

    will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects

  2. ECGs

    Time frame: 6 weeks

    will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects

  3. Blood pressure

    Time frame: 6 weeks

    will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects

  4. pulse rate

    Time frame: 6 weeks

    will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects

  5. Injection siter reaction

    Time frame: 6 weeks

    The number and percentage of subjects that experienced injection site reactions will be analyzed.

  6. number of subjects with adverse events

    Time frame: 6 weeks

    will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects

  7. severity of adverse events

    Time frame: 6 weeks

    will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects

Secondary outcomes

  1. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 6 weeks

  2. Area under the Concentration-Time Curve (AUC)

    Time frame: 6 weeks

    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

  3. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Dose Expansion Of A Within-cohort, Randomized, Double-blind, Third-party Open, Placebo-controlled, Single-and Multiple-dose Escalation Study To Evaluate Safety, Tolerability, And Pharmacokinetics Of Pf-06473871 In Normal Healthy Adults

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 20, 2012
Registry last updated
Sep 26, 2014

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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