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OpenTrials
Completed

NCT Number: NCT01637285

A Pharmacokinetic Study of CVX-096 (PF-04856883) in Healthy Volunteers

The purpose of the study is to further evaluate the PK characteristics of PF-04856883.

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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

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

-

Exclusion criteria

-

Treatment and study plan

PF-04856883

Biological

Dose A

Primary outcomes

  1. PF-04856883 Pharmacokinetics including Cmax, Tmax, AUCo-infinity, AUClast, Cl/F, Vz/F and t1/2

    Time frame: 4 weeks

Secondary outcomes

  1. Number of subjects with AEs reported

    Time frame: 4 weeks

  2. Number of subjects with abnormal physical examination findings

    Time frame: 4 weeks

  3. Number of subjects with abnormal clinical laboratory results

    Time frame: 4 weeks

  4. Number of subjects with abnormal ECGs

    Time frame: 4 weeks

  5. Number of subjects with abnormal vital signs

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Randomized, Open-label, Parallel-group Study To Evaluate The Pharmacokinetics Of Pf-04856883 (Cvx-096) Following Subcutaneous Administration In Healthy Volunteers

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 11, 2012
Registry last updated
Jul 31, 2015

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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