NCT02684760

Brief Summary

PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will test the bioavailability of a solid dose formulation of PF-06651600 compared to an oral solution formulation under fasting conditions and the effect of a high fat meal on the bioavailability of the solid dose formulation of PF-06651600 in healthy subjects. Safety and tolerability of the tablet and oral solution formulations of PF-06651600 will be assessed under fasting and fed conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Feb 2016

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

February 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 16, 2016

Status Verified

June 1, 2016

Enrollment Period

3 months

First QC Date

February 12, 2016

Last Update Submit

June 14, 2016

Conditions

Healthy

Keywords

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (3)

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

    Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)

    0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06651600

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

    0, 0.25, 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

    Time to Reach Maximum Observed Plasma Concentration (Cmax)

    0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

Secondary Outcomes (2)

  • Plasma Decay Half Life (t1/2) for PF-06651600

    0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

  • Time to Reach Maximum Concentration (Tmax) for PF-06651600

    0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

Study Arms (6)

Cohort 1: PF-06651600

EXPERIMENTAL

Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.

Drug: PF-06651600

Cohort 2: PF-06651600

EXPERIMENTAL

Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.

Drug: PF-06651600

Cohort 3: PF-06651600

EXPERIMENTAL

Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.

Drug: PF-06651600

Cohort 4: PF-06651600

EXPERIMENTAL

Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.

Drug: PF-06651600

Cohort 5: PF-06651600

EXPERIMENTAL

Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.

Drug: PF-06651600

Cohort 6: PF-06651600

EXPERIMENTAL

Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.

Drug: PF-06651600

Interventions

PF-06651600DRUG

PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort.

Cohort 1: PF-06651600Cohort 2: PF-06651600Cohort 3: PF-06651600Cohort 4: PF-06651600Cohort 5: PF-06651600Cohort 6: PF-06651600

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).
  • Prior history of chicken pox.
  • 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.

You may not qualify if:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
  • 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, 1070, Belgium

Location

Related Publications (3)

  • 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

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
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2016

First Posted

February 18, 2016

Study Start

February 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 16, 2016

Record last verified: 2016-06

Locations

BE(1)