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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: PF-06700841

• Registration Number: NCT03236493
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-28
• Study First Submitted QC: 2017-07-28
• Study First Posted: 2017-08-02
• Study Start: 2017-08-16
• Primary Completion: 2017-09-17
• Status Verified: 2017-10
• Study Completion: 2017-10-12
• Last Update Submitted: 2017-10-23
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Multiple ascending doses of Placebo
PF-06700841	PF-06700841	Multiple ascending doses of PF-06700841

Primary Outcome Measures

Name	Time	Method
Number of Participants With Laboratory Abnormalities	Baseline up to Day 28
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 Vital Signs (Blood Pressure, Pulse Rate, Oral Temperature)	Baseline, Day 1, 10, 13 and 28
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
Number of Participants With Change From Baseline in Physical Examinations	Baseline up to Day 28

Secondary Outcome Measures

Name	Time	Method
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 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
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
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
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
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
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
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
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
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
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
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
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

Trial Locations

Locations (1)

Pfizer Clinical Research Unit; 🇧🇪 Brussels, Belgium