NCT04580797

Brief Summary

The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of PF-06700841 following single and multiple oral doses as modified release (MR) formulations in healthy, adult participants under fasted and fed conditions. The objective of Part A is to evaluate the relative bioavailability and food effect of 2 new MR formulations, MR1 and MR2. The objective of Part B is to evaluate the PK and safety/tolerability of MR3 formulation following multiple dose administration over a 7-day period. Overall, results from both parts will facilitate further development of an MR formulation for future clinical studies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

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

September 25, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

October 2, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2021

Completed
Last Updated

March 8, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

September 25, 2020

Last Update Submit

March 4, 2021

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (5)

  • Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part A

    pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose

  • Area under the plasma concentration-time curve from time zero to the last measured concentration (AUClast) of PF-06700841 in Part A

    pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose

  • Area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUCinf) of PF-06700841 if data permit in Part A

    pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose

  • Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part A

    pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hours post dose

  • Number of participants with Treatment- Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation due to AEs in Part B

    Baseline to Day 10

Secondary Outcomes (11)

  • Number of subjects with clinically relevant changes in Electrocardiogram (ECG) parameters in Part A

    Pre-dose and 96 hours post dose

  • Number of subjects with clinically relevant changes in vital signs in Part A

    Pre-dose and 96 hours post dose

  • Number of participants with clinically relevant changes in clinical laboratory tests in Part A

    Baseline and 96 hours post dose

  • Number of participants with Treatment- Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation due to AEs in Part A

    Baseline to Day 4

  • Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part B on Day 1

    pre-dose, 1,2,3,4,6,8,10,12,16 hours post dose on Day 1

  • +6 more secondary outcomes

Study Arms (9)

PF-06700841: IR, MR1, MR2, MR1_fed

EXPERIMENTAL

Participants receive single doses of immediate release (IR) followed by modified release (MR) MR1 and MR2, all in fasted condition followed by MR1 in fed condition in Periods 1-4

Drug: PF-06700841 IRDrug: PF-06700841 MR1Drug: PF-06700841 MR2

PF-06700841: MR1, MR2, IR, MR1_fed

EXPERIMENTAL

Participants receive single doses of MR1 followed by MR2 and IR, all in fasted condition followed by MR1 in fed condition in Periods 1-4

Drug: PF-06700841 IRDrug: PF-06700841 MR1Drug: PF-06700841 MR2

PF-06700841: MR2, IR, MR1, MR1_fed

EXPERIMENTAL

Participants receive single doses of MR2 followed by IR and MR1, all in fasted condition followed by MR1 in fed condition in Periods 1-4

Drug: PF-06700841 IRDrug: PF-06700841 MR1Drug: PF-06700841 MR2

PF-06700841: IR, MR1, MR2, MR2_fed

EXPERIMENTAL

Participants receive single doses of IR followed by MR1 and MR1, all in fasted condition followed by MR2 in fed condition in Periods 1-4

Drug: PF-06700841 IRDrug: PF-06700841 MR1Drug: PF-06700841 MR2

PF-06700841: MR1, MR2, IR, MR2_fed

EXPERIMENTAL

Participants receive single doses of MR1 followed by MR2 and IR, all in fasted condition followed by MR2 in fed condition in Periods 1-4

Drug: PF-06700841 IRDrug: PF-06700841 MR1Drug: PF-06700841 MR2

PF-06700841: MR2, IR, MR1, MR2_fed

EXPERIMENTAL

Participants receive single doses of MR2 followed by IR and MR1, all in fasted condition followed by MR2 in fed condition in Periods 1-4

Drug: PF-06700841 IRDrug: PF-06700841 MR1Drug: PF-06700841 MR2

PF-06700841 MR3 (Dose A) or matching placebo

EXPERIMENTAL

Participants receive dosing regimen 1 of MR3 (Dose A) or matching placebo for 7 days under fasted condition

Drug: PF-06700841 MR3Other: Placebo

PF-06700841 MR3 (Dose B) or matching placebo

EXPERIMENTAL

Participants receive dosing regimen 1 of MR3 (Dose B) or matching placebo for 7 days under fasted condition

Drug: PF-06700841 MR3Other: Placebo

PF-06700841 MR3 (Dose C) or matching placebo

EXPERIMENTAL

Participants receive dosing regimen 1 of MR3 (Dose C) or matching placebo for 7 days under fasted condition

Drug: PF-06700841 MR3Other: Placebo

Interventions

PF-06700841 IRDRUG

Immediate release formulation

PF-06700841: IR, MR1, MR2, MR1_fedPF-06700841: IR, MR1, MR2, MR2_fedPF-06700841: MR1, MR2, IR, MR1_fedPF-06700841: MR1, MR2, IR, MR2_fedPF-06700841: MR2, IR, MR1, MR1_fedPF-06700841: MR2, IR, MR1, MR2_fed
PF-06700841 MR1DRUG

Modified release formulation 1

PF-06700841: IR, MR1, MR2, MR1_fedPF-06700841: IR, MR1, MR2, MR2_fedPF-06700841: MR1, MR2, IR, MR1_fedPF-06700841: MR1, MR2, IR, MR2_fedPF-06700841: MR2, IR, MR1, MR1_fedPF-06700841: MR2, IR, MR1, MR2_fed
PF-06700841 MR2DRUG

Modified release formulation 2

PF-06700841: IR, MR1, MR2, MR1_fedPF-06700841: IR, MR1, MR2, MR2_fedPF-06700841: MR1, MR2, IR, MR1_fedPF-06700841: MR1, MR2, IR, MR2_fedPF-06700841: MR2, IR, MR1, MR1_fedPF-06700841: MR2, IR, MR1, MR2_fed
PF-06700841 MR3DRUG

Modified release formulation 3

PF-06700841 MR3 (Dose A) or matching placeboPF-06700841 MR3 (Dose B) or matching placeboPF-06700841 MR3 (Dose C) or matching placebo
PlaceboOTHER

Matching placebo

PF-06700841 MR3 (Dose A) or matching placeboPF-06700841 MR3 (Dose B) or matching placeboPF-06700841 MR3 (Dose C) or matching placebo

Eligibility Criteria

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

You may qualify if:

  • Healthy male and female participants between 18 -55 years of age.
  • BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).
  • Participants who are willing and able to comply with all scheduled visits, treatment
  • plan, laboratory tests, lifestyle considerations, and other study procedures.

You may not qualify if:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Conditions that affect drug absorption (e.g., gastrectomy cholecystectomy)
  • History of venous and arterial thrombosis (ie, deep venous thrombosis, pulmonary embolism) or hereditary clotting disorders (in first degree immediate relatives)
  • Positive urine drug test.
  • History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
  • History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Quotient Sciences

Coral Gables, Florida, 33134, United States

Location

Quotient Sciences-Miami

Miami, Florida, 33126, United States

Location

Related Links

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
Masking Details
Part B is a sponsor open, double blind study where the investigator, medical monitor and the participants will be blinded.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Part A is a partial cross over study with 4 periods; the first three periods are IR, MR1, MR2 in fasted condition and the fourth arm is either MR1 or MR2 in fed condition. Part B is a multiple ascending dose study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2020

First Posted

October 8, 2020

Study Start

October 2, 2020

Primary Completion

January 11, 2021

Study Completion

January 11, 2021

Last Updated

March 8, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Locations

US(2)