Safety and Pharmacokinetic Study of PF-06651600 in Healthy Volunteers
NCT ID: NCT02309827
Last Updated: 2016-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
80 participants
INTERVENTIONAL
2014-12-31
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
DOUBLE
Study Groups
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Cohort 1: PF-06651600 or Placebo
Single ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
PF-06651600 or Placebo
PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort.
Cohort 2: PF-06651600 or Placebo
Single ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
PF-06651600 or Placebo
PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort.
Cohort 3: PF-06651600 or Placebo
Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
PF-06651600 or Placebo
PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort.
Cohort 4: PF-06651600 or Placebo
Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
PF-06651600 or Placebo
PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort.
Cohort 5: PF-06651600 or Placebo
Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
PF-06651600 or Placebo
PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort.
Cohort 6: PF-06651600 or Placebo
Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
PF-06651600 or Placebo
PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort.
Cohort 7: PF-06651600 or Placebo
Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
PF-06651600 or Placebo
PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort.
Cohort 8: PF-06651600 or Placebo
Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
PF-06651600 or Placebo
PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort.
Cohort 9: PF-06651600 or Placebo
Multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.
PF-06651600 or Placebo
PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort.
Interventions
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PF-06651600 or Placebo
PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort.
Eligibility Criteria
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Inclusion Criteria
* BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Evidence of personally signed and dated informed consent document.
* Willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures.
* Subjects must avoid high intensity UV light exposure (eg, active sunbathing, tanning beds/booths or sunlamps) from the first dose of study drug and for the duration of the study.
Exclusion Criteria
* Use of tobacco/nicotine containing products in excess of 5 cigarettes/day.
* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
* Screening blood pressure \>140/90 mm Hg.
* Screening laboratory abnormalities as defined by the protocol.
* Unwilling or unable to comply with the Lifestyle Guidelines as defined by the protocol.
18 Years
55 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Clinical Research Unit
Brussels, , Belgium
Countries
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References
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Saadeddin A, Purohit V, Huh Y, Wong M, Maulny A, Dowty ME, Sagawa K. Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model. AAPS J. 2024 Jan 24;26(1):17. doi: 10.1208/s12248-024-00888-9.
Wojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023 Dec;62(12):1765-1779. doi: 10.1007/s40262-023-01318-3. Epub 2023 Nov 2.
Purohit V, Huh Y, Wojciechowski J, Plotka A, Salts S, Antinew J, Dimitrova A, Nicholas T. Leveraging Prior Healthy Participant Pharmacokinetic Data to Evaluate the Impact of Renal and Hepatic Impairment on Ritlecitinib Pharmacokinetics. AAPS J. 2023 Mar 28;25(3):32. doi: 10.1208/s12248-023-00792-8.
Telliez JB, Dowty ME, Wang L, Jussif J, Lin T, Li L, Moy E, Balbo P, Li W, Zhao Y, Crouse K, Dickinson C, Symanowicz P, Hegen M, Banker ME, Vincent F, Unwalla R, Liang S, Gilbert AM, Brown MF, Hayward M, Montgomery J, Yang X, Bauman J, Trujillo JI, Casimiro-Garcia A, Vajdos FF, Leung L, Geoghegan KF, Quazi A, Xuan D, Jones L, Hett E, Wright K, Clark JD, Thorarensen A. Discovery of a JAK3-Selective Inhibitor: Functional Differentiation of JAK3-Selective Inhibition over pan-JAK or JAK1-Selective Inhibition. ACS Chem Biol. 2016 Dec 16;11(12):3442-3451. doi: 10.1021/acschembio.6b00677. Epub 2016 Nov 10.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2014-004326-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PF-06651600
Identifier Type: OTHER
Identifier Source: secondary_id
JAK3
Identifier Type: OTHER
Identifier Source: secondary_id
B7981001
Identifier Type: -
Identifier Source: org_study_id
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