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

Healthy Clinical Trial

Official title:

A Phase 1, Randomized, Double-blind, Third-party Open, Placebo-controlled Study To Evaluate The Safety, Tolerability, And Pharmacokinetics After Multiple Oral Doses Of Pf-06700841 In Healthy Japanese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03236493
• Other study ID #: B7931009
• Secondary ID: 2017-002066-41
• Status: Completed
• Phase: Phase 1
• First received: July 28, 2017
• Last updated: October 23, 2017
• Start date: August 16, 2017
• Est. completion date: October 12, 2017

Study information

• Verified date: October 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 12, 2017
• Est. primary completion date: September 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-06700841
PF-06700841 will be administered as tablet
• Placebo
Matching placebo will be administered as tablet

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs		Baseline up to Day 45
Primary	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
Primary	Change From Baseline in Vital Signs (Blood Pressure, Pulse Rate, Oral Temperature)		Baseline, Day 1, 10, 13 and 28
Primary	Number of Participants With Change From Baseline in Physical Examinations		Baseline up to Day 28
Primary	Number of Participants With Laboratory Abnormalities		Baseline up to Day 28
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06700841 at Day 1		pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1
Secondary	Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06700841 at Day 1		pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1
Secondary	Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) 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
Secondary	Plasma Decay Half-Life (t1/2) of PF-06700841 at Day 1		pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1
Secondary	Plasma Decay Half-Life (t1/2) 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
Secondary	Observed Accumulation Ratio (Rac) on AUCtau for 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
Secondary	Observed Accumulation Ratio on Cmax (RacCmax) for 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
Secondary	MinimumObserved Plasma Concentration (Cmin) 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

External Links

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