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Completed

NCT Number: NCT01626976

A Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-06282999 Administered Orally In Healthy Adult Subjects

This is the first-in-human study for an oral investigational compound, PF-06282999, in order to assess its safety, tolerability and pharmacokinetics in humans across a wide range of dose levels.

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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 Investigational Site

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 female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
  • Women must be of non-childbearing potential.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of ≤1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.

Treatment and study plan

PF-06282999

Drug

Solution, doses range from 20 to 200 mg, single dose

Placebo

Drug

Solution, single dose

Primary outcomes

  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose

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

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose

  3. Area Under the Curve From Time Zero to 24 hour [AUC24]

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose

  4. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose

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

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose

  6. Apparent Oral Clearance (CL/F)

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose

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

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose

  8. Apparent Volume of Distribution (Vz/F)

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose

  9. Amount of Unchanged Drug Excretion in Urine from Zero to 24 hours (Ae24)

    Time frame: 0 to 24 hours post-dose

  10. Percent of Dose Excreted in Urine as Unchanged Drug from Zero to 24 hours (Ae24%)

    Time frame: 0 to 24 hours post-dose

  11. Renal Clearance (CLr)

    Time frame: 0 to 24 hours post-dose

  12. Oral temperature

    Time frame: 0, 1, 2, 4, 8, 12,16, 24, 48 hours post-dose

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Controlled, Single Dose Escalating Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-06282999 Administered Orally In Healthy Adult Subjects

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 25, 2012
Registry last updated
Mar 13, 2013

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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