Clinical Study to Evaluate Blood Concentrations of PF-06700841 After Oral Dose as Different Formulations

NCT03765554 | Completed Phase 1 FDA Drug

• 2 other identifiers: B79310102018-003512-41
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

PF-06700841 is a dual Tyrosine kinase 2 (TYK2) Janus kinase 1 (JAK1) inhibitor that is being developed for oral treatment of adult patients with Inflammatory Bowel Disease (IBD).This open-label study will evaluate the pharmacokinetics of PF-06700841 following single oral doses of immediate release (IR) and modified release (MR) tablets in healthy, adult participants under fasted conditions. This is an open label, single dose, randomized, 2 period, 2- sequence crossover study in a single cohort of approximately 8 (minimum 6) healthy participants.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (4)

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

  pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose

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

  pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose

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

  pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose

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

  pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose

Secondary Outcomes (7)

• Change from baseline in 12-Lead Electrocardiogram (ECG) parameters - PR interval, QRS complex, QT interval and QTC interval

  Pre-dose and 48 hours post-dose

• Change from baseline in heart rate

  Pre-dose and 48 hours post-dose

• Change from baseline in blood pressure

  Pre-dose and 48 hours post-dose

• Change from baseline in pulse rate

  Pre-dose and 48 hours post-dose

• Change from baseline in oral temperature

  Pre-dose and 48 hours post-dose

Study Arms (2)

PF-06700841: IR followed by MR

EXPERIMENTAL

Participants receive PF-06700841 Immediate release tablets (IR) followed by PF-06700841 Modified release tablets (MR)

Drug: PF-06700841 Immediate release tablets; Drug: PF-06700841 Modified release tablets

PF-06700841: MR followed by IR

EXPERIMENTAL

Participants receive PF-06700841 Modified release tablets (MR) followed by PF-06700841 Immediate release tablets (IR)

Drug: PF-06700841 Immediate release tablets; Drug: PF-06700841 Modified release tablets

Interventions

PF-06700841 Immediate release tablets DRUG

Small molecule tablets in immediate release form

PF-06700841: IR followed by MR; PF-06700841: MR followed by IR

PF-06700841 Modified release tablets DRUG

Small molecule tablets in modified release form

PF-06700841: IR followed by MR; PF-06700841: MR followed by IR

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male, and female participants between the ages of 18 and 55 years at the time of screening, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
• Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
• 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:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• Any condition possibly affecting drug absorption (eg, gastrectomy).
• Have or have had clinically significant infections within the past 3 months prior to the first dose of investigational product (eg, those requiring hospitalization or parenteral antibiotics, or as judged by the Investigator), evidence of any infection within the past 7 days prior to the first dose of investigational product, herpes simplex within 12 weeks or history of disseminated herpes simplex infection, symptomatic herpes zoster or recurrent (\>1 episode) or disseminated herpes zoster.
• History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb) or hepatitis C antibody (HCVAb). As an exception, a positive hepatitis B surface antibody (HepBsAb) finding as a result of participant vaccination is permissible.
• History of tuberculosis or active or latent or inadequately treated infection, positive QuantiFERON tuberculosis (TB) Gold test.
• Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product used in this study (whichever is longer).
• Female participants who are pregnant or wish to become pregnant; breastfeeding females.
• Males/Females of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
• Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.
• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

PF-06700841

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: November 28, 2018
• First Posted: December 5, 2018
• Study Start: January 7, 2019
• Primary Completion: April 3, 2019
• Study Completion: April 3, 2019
• Last Updated: May 9, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)