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Completed

NCT Number: NCT03309241

First In Human, Single Escalating Oral Dose Study Of PF-06882961 In Healthy Adult Subjects

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of PF-06882961 in healthy adult subjects. This is the first clinical study of PF-06882961.

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Key information

Conditions

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

  • Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive
  • Body mass index (BMI) within 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal (including pancreatitis), cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of IP (whichever is longer).
  • Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days after the last dose.
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose

Treatment and study plan

PF-06882961

Drug

Single Ascending Doses of PF-06882961 from 3mg to TBD mg.

Placebo

Other

Placebo Single Dose

Primary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Seriousness and Relationship to Treatment

    Time frame: First dose of study drug up to 28 days after last dose of study drug

    Assessment by adverse event monitoring, 12 lead ECGs, cardiac telemetry, vital signs and clinical safety laboratory measurements.

Secondary outcomes

  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Time frame: Pre-dose and at 0.3, 0.75, 1.25,2,3,4,6,8,10,12,24,36,48 hours following single dose administration

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Pre-dose and at 0.3, 0.75, 1.25,2,3,4,6,8,10,12,24,36,48 hours following single dose administration

    Maximum Observed Plasma Concentration (Cmax)

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

    Time frame: Pre-dose and at 0.3, 0.75, 1.25,2,3,4,6,8,10,12,24,36,48 hours following single dose administration

    Time to Reach Maximum Observed Plasma Concentration (Tmax)

  4. Plasma Decay Half-Life (t1/2)

    Time frame: Pre-dose and at 0.3, 0.75, 1.25,2,3,4,6,8,10,12,24,36,48 hours following single dose administration

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06882961 In Healthy Adult Subjects

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 13, 2017
Registry last updated
Apr 2, 2018

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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