NCT02309827

Brief Summary

This study is a first in human study of PF-06651600. PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will test single and multiple doses of PF-06651600. The goal of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-06651600 in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Dec 2014

Longer than P75 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

Study Start

First participant enrolled

December 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

September 19, 2016

Status Verified

September 1, 2016

Enrollment Period

1.3 years

First QC Date

December 3, 2014

Last Update Submit

September 15, 2016

Conditions

Healthy

Keywords

Inflammatory bowel disease

Outcome Measures

Primary Outcomes (8)

  • 24 hour creatinine clearance (Single Dose)

    24 hour urine creatinine clearance in healthy subjects participating in the single dose periods. For the single dose period, assessment occurs on Study Days 0 and 1.

    Single dose period, Day 0 (baseline) and 24 hours post dose Day 1.

  • 24 hour creatinine clearance (Multiple Dose)

    24 hour urine creatinine clearance in healthy subjects participating in the multiple dose period. For the multiple ascending dose period assessments occur on Study Days 7 and 14.

    Multiple dose period, Days 0 (baseline), 7 and 14.

  • Change from baseline in urine volume (Single Dose)

    For the single dose period, assessment occurs on Study Days 0 and 1.

    Single dose period, Day 0 (baseline) and 24 hours post dose Day 1.

  • Change from baseline in urine electrolytes (Single Dose)

    For the single dose period, assessment occurs on Study Days 0 and 1.

    Single dose period, Day 0 (baseline) and 24 hours post dose Day 1.

  • Change from baseline in urine osmolality (Single Dose)

    For the single dose period, assessment occurs on Study Days 0 and 1.

    Single dose period, Day 0 (baseline) and 24 hours post dose Day 1.

  • Change from baseline of urine volume (Multiple Dose)

    For the multiple ascending dose period assessments occur on Study Days 7 and 14.

    Multiple dose period, Days 0 (baseline), 7 and 14.

  • Change from baseline of urine electrolytes (Multiple Dose)

    For the multiple ascending dose period assessments occur on Study Days 7 and 14.

    Multiple dose period, Days 0 (baseline), 7 and 14.

  • Change from baseline in urine osmolality (Multiple Dose)

    For the multiple ascending dose period assessments occur on Study Days 7 and 14.

    Multiple dose period, Days 0 (baseline), 7 and 14.

Secondary Outcomes (41)

  • Maximum Observed Plasma Concentration (Cmax) for PF-06651600 (Single Dose)

    0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

  • Maximum Observed Plasma Concentration (Cmax) for PF-06651600 (Multiple Dose)

    Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)

  • Time to Reach Maximum Observed Plasma Concentration (Cmax) for PF-06651600 (Single Dose)

    0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

  • Time to Reach Maximum Observed Plasma Concentration (Cmax) for PF-06651600 (Multiple Dose)

    Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose)

  • Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-06651600 (Single Dose)

    0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

  • +36 more secondary outcomes

Study Arms (9)

Cohort 1: PF-06651600 or Placebo

EXPERIMENTAL

Single ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.

Drug: PF-06651600 or Placebo

Cohort 2: PF-06651600 or Placebo

EXPERIMENTAL

Single ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.

Drug: PF-06651600 or Placebo

Cohort 3: PF-06651600 or Placebo

EXPERIMENTAL

Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.

Drug: PF-06651600 or Placebo

Cohort 4: PF-06651600 or Placebo

EXPERIMENTAL

Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.

Drug: PF-06651600 or Placebo

Cohort 5: PF-06651600 or Placebo

EXPERIMENTAL

Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.

Drug: PF-06651600 or Placebo

Cohort 6: PF-06651600 or Placebo

EXPERIMENTAL

Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.

Drug: PF-06651600 or Placebo

Cohort 7: PF-06651600 or Placebo

EXPERIMENTAL

Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.

Drug: PF-06651600 or Placebo

Cohort 8: PF-06651600 or Placebo

EXPERIMENTAL

Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.

Drug: PF-06651600 or Placebo

Cohort 9: PF-06651600 or Placebo

EXPERIMENTAL

Multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.

Drug: PF-06651600 or Placebo

Interventions

PF-06651600 or PlaceboDRUG

PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort.

Cohort 1: PF-06651600 or PlaceboCohort 2: PF-06651600 or PlaceboCohort 3: PF-06651600 or PlaceboCohort 4: PF-06651600 or PlaceboCohort 5: PF-06651600 or PlaceboCohort 6: PF-06651600 or PlaceboCohort 7: PF-06651600 or PlaceboCohort 8: PF-06651600 or PlaceboCohort 9: PF-06651600 or Placebo

Eligibility Criteria

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

You may qualify if:

  • Healthy male/female subjects between 18 and 55 years old, inclusive. Females must be of non-child bearing potential.
  • 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.

You may not qualify if:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Related Publications (4)

  • 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.

    PMID: 38267790DERIVED

  • 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.

    PMID: 37917289DERIVED

  • 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.

    PMID: 36977960DERIVED

  • 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.

    PMID: 27791347DERIVED

Related Links

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

PF-06651600

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

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
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2014

First Posted

December 5, 2014

Study Start

December 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

September 19, 2016

Record last verified: 2016-09

Locations

BE(1)