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Completed

NCT Number: NCT04580797

Clinical Study to Evaluate Pharmacokinetics and Safety of PF-06700841 After Single and Multiple Oral Doses as Modified Release Formulations

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.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences, Coral Gables, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

PF-06700841 IR

Drug

Immediate release formulation

PF-06700841 MR1

Drug

Modified release formulation 1

PF-06700841 MR2

Drug

Modified release formulation 2

PF-06700841 MR3

Drug

Modified release formulation 3

Placebo

Other

Matching placebo

Primary outcomes

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

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

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

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

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

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

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

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

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

    Time frame: Baseline to Day 10

Secondary outcomes

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

    Time frame: Pre-dose and 96 hours post dose

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

    Time frame: Pre-dose and 96 hours post dose

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

    Time frame: Baseline and 96 hours post dose

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

    Time frame: Baseline to Day 4

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

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

  6. Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part B on Day 1

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

  7. Maximum Observed Plasma Concentration (Cmax) of PF-06700841 in Part B on Day 7

    Time frame: pre-dose on Day 7, 1,2,3 4,6,8,12,16,24,48,72 hours post dose on Day 7

  8. Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 in Part B on Day 7

    Time frame: pre-dose on Day 7, 1,2,3 4,6,8,12,16,24,48,72 hours post dose on Day 7

  9. Area under the plasma concentration-time curve from time zero to 24 hours (AUC24) of PF-06700841 in Part B on Day 1

    Time frame: pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1, pre-dose on Day 3 and Day 5, pre-dose on Day 7, 1,2,3,4,6,8,12,16,24,48,72 hours post dose on Day 7

  10. Area under the plasma concentration-time curve from time zero to 24 hours (AUCtau) of PF-06700841 in Part B on Day 7

    Time frame: pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1, pre-dose on Day 3 and Day 5, pre-dose on Day 7, 1,2,3,4,6,8,12,16,24,48,72 hours post dose on Day 7

  11. Terminal half-life of PF-06700841 in Part B

    Time frame: pre-dose, 1,2,4,6,8,10,12,16 hours post dose on Day 1, pre-dose on Day 3 and Day 5, pre-dose on Day 7, 1,2,3,4,6,8,12,16,24,48,72 hours post dose on Day 7

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 1, OPEN-LABEL STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE PHARMACOKINETICS OF PF-06700841 FOLLOWING SINGLE ORAL ADMINISTRATION OF MODIFIED RELEASE FORMULATIONS UNDER FED AND FASTED CONDITIONS IN PART A AND A RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED STUDY TO EVALUATE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF-06700841 FOLLOWING MULTIPLE ORAL ADMINISTRATION OF MODIFIED RELEASE FORMULATION UNDER FASTED CONDITION IN PART B

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 8, 2020
Registry last updated
Mar 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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