Safety and Pharmacokinetic Study of PF-06700841 in Japanese Healthy Volunteers

NCT03236493 | Completed Phase 1

• 2 other identifiers: B79310092017-002066-41
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a phase 1 study of PF-06700841. PF-06700841 is being developed for treatment of inflammatory bowel disease. The goal of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-06700841 after multiple oral doses of PF-06700841 in Japanese healthy volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs

  Baseline up to Day 45

• Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS interval, QT Interval, QTC Interval, heart rate)

  Baseline, 1 hour post-dose on Day 1 and 10

• Change From Baseline in Vital Signs (Blood Pressure, Pulse Rate, Oral Temperature)

  Baseline, Day 1, 10, 13 and 28

• Number of Participants With Change From Baseline in Physical Examinations

  Baseline up to Day 28

• Number of Participants With Laboratory Abnormalities

  Baseline up to Day 28

Secondary Outcomes (13)

• Maximum Observed Plasma Concentration (Cmax) of PF-06700841 at Day 1

  pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1

• Maximum Observed Plasma Concentration (Cmax) of PF-06700841 at Day 10

  pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72 hour post-dose on Day 10

• Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841 at Day 1

  pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1

• Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841 at Day 10

  pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72 hour post-dose on Day 10

• Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06700841 at Day 1

  pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1

Study Arms (2)

PF-06700841

EXPERIMENTAL

Multiple ascending doses of PF-06700841

Drug: PF-06700841

Placebo

PLACEBO COMPARATOR

Multiple ascending doses of Placebo

Drug: Placebo

Interventions

PF-06700841 DRUG

PF-06700841 will be administered as tablet

PF-06700841

Placebo DRUG

Matching placebo will be administered as tablet

Placebo

Eligibility Criteria

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

You may qualify if:

• Subject must have four Japanese grandparents who were born in Japan.
• Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive
• No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
• BMI of 17.5 to 27.5 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.

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Related Publications (1)

• Hughes JH, Qiu R, Banfield C, Dowty ME, Nicholas T. Population Pharmacokinetics of Oral Brepocitinib in Healthy Volunteers and Patients. Clin Pharmacol Drug Dev. 2022 Dec;11(12):1447-1456. doi: 10.1002/cpdd.1163. Epub 2022 Aug 31.

  PMID: 36045513 DERIVED

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 2, 2017
• Study Start: August 16, 2017
• Primary Completion: September 17, 2017
• Study Completion: October 12, 2017
• Last Updated: October 25, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)