NCT02224651

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Sep 2014

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2014

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 2, 2015

Status Verified

July 1, 2015

Enrollment Period

9 months

First QC Date

August 21, 2014

Last Update Submit

July 1, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events

    Baseline-5 days

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

    Baseline-5 days

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

    Quantitative changes in ECG intervals

    Baseline-5 days

  • 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

    Baseline-5 days

Secondary Outcomes (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 fasted condition

    Baseline-5 days

  • 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

    Baseline-5 days

Study Arms (4)

(1-1000mg) Immediate Release formulation

EXPERIMENTAL
Drug: PF-06650833

Immediate Release Placebo arm

PLACEBO COMPARATOR
Drug: Placebo

(10-500) mg Modified Release formulation

EXPERIMENTAL
Drug: PF-06650833

Modified Release Placebo arm

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PF-06650833DRUG

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.

(1-1000mg) Immediate Release formulation
PlaceboDRUG

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

Immediate Release Placebo arm

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

  • Danto SI, Shojaee N, Singh RSP, Li C, Gilbert SA, Manukyan Z, Kilty I. Safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06650833, a selective interleukin-1 receptor-associated kinase 4 (IRAK4) inhibitor, in single and multiple ascending dose randomized phase 1 studies in healthy subjects. Arthritis Res Ther. 2019 Dec 5;21(1):269. doi: 10.1186/s13075-019-2008-6.

    PMID: 31805989DERIVED

Related Links

MeSH Terms

Interventions

1-(((2S,3S,4S)-3-ethyl-4-fluoro-5-oxopyrrolidin-2-yl)methoxy)-7-methoxyisoquinoline-6-carboxamide

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2014

First Posted

August 25, 2014

Study Start

September 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 2, 2015

Record last verified: 2015-07

Locations

US(1)