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Completed

NCT Number: NCT02224651

Study to Evaluate Safety and Tolerability of Single Ascending Doses of Multiple Formulations of PF-06650833 in Healthy Subjects Under Fasted and Fed Conditions

This single ascending dose study is the first evaluation of PF-06650833 in humans. The goals are to assess the safety, tolerability and blood levels of ascending doses of multiple formulations of PF-06650833 and to perform a preliminary assessment of the effect of food on exposure, in healthy subjects.

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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

  • Healthy male and/or female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion criteria

  • Screening supine blood pressure 100 mm Hg (systolic) or 50 mm Hg (diastolic); or 140 mm Hg (systolic) or 90 mm Hg (diastolic) following at least 5 minutes of supine rest. If blood pressure (BP) is 140 mm Hg (systolic) or 90 mm Hg (diastolic), the BP should be repeated two more times and the average of the three BP values should be used to determine the subject's eligibility.
  • Pulse or heart rate (HR) >100 bpm after at least 5 minutes of rest. If the pulse/HR is >100 bpm, the pulse/HR should be repeated two more times (separated by at least 2 minutes) and the average of the three pulse/HR values should be used to determine the subject's eligibility.

Treatment and study plan

PF-06650833

Drug

Subjects will receive sequential single escalating doses of 1-1000 mg of Immediate Release of PF-06650833 (as solution/suspension) under fed and / or fasted conditions.

Placebo

Drug

Subjects will receive sequential single escalating doses of PF-06650833 matching placebo (as solution/suspension) under fed and/ or fasted conditions.

Primary outcomes

  1. Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events

    Time frame: Baseline-5 days

  2. Changes from baseline in vital signs ( blood pressure, pulse rate, respiratory rate and orthostatic blood pressure)

    Time frame: Baseline-5 days

  3. Changes from baseline in ECG parameters (standard 12 lead ECG and telemetry)

    Time frame: Baseline-5 days

    Quantitative changes in ECG intervals

  4. Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology, chemistry (including, cardiac enzymes CK, CK MB and cardiac Troponin I), serum myoglobin, urinalysis

    Time frame: Baseline-5 days

Secondary outcomes

  1. Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, Cmax(dn), AUCinf(dn), AUClast(dn), t½, mean residence time (MRT) for IR and MR formulations under fasted condition

    Time frame: Baseline-5 days

  2. Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, Cmax(dn), AUCinf(dn), AUClast(dn), t½, mean residence time (MRT) for IR and MR formulations under fed condition

    Time frame: Baseline-5 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Substitution, Crossover, Single Dose Escalation Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Pf 06650833 Delivered In Multiple Formulations In Healthy Subjects Under Fasted And Fed Conditions

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 25, 2014
Registry last updated
Jul 2, 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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