Study for MR Formulation of PF-06650833 in Healthy Adult Japanese Subjects

NCT02936154 | Completed Phase 1

• 1 other identifier: B7921006
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the tolerability, safety and pharmacokinetics of PF-06650833 orally administered as modified release tablets in healthy Japanese subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of participants experiencing an AE/SAE

  Day 18

Secondary Outcomes (13)

• Maximum plasma concentration (Cmax)

  Day 1 and Day 10

• Area under the plasma concentration time curve for dosing interval (AUCtau)

  Day 1 and Day 10

• Time to peak concentration

  Day 1 and Day 10

• Clearance

  Day 10

• Volume of distribution

  Day 10

Study Arms (2)

300 mg

EXPERIMENTAL

Drug: PF-06650833

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

PF-06650833 DRUG

300 mg

placebo DRUG

placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy female subjects of non childbearing potential and/or male Japanese subjects between the ages of 20 and 55 years, inclusive.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
• Subject must have four Japanese grandparents who were born in Japan.
• Evidence of a personally signed and dated informed consent document.
• Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
• Any condition possibly affecting drug absorption (eg, gastrectomy).
• A positive urine drug screen.
• Smoking cigarettes with exceeding provided criteria.
• History of regular alcohol consumption exceeding provided limitations.
• Treatment with an investigational drug within a provided criteria.
• Abnormal supine blood pressure.
• Abnormal pulse rate.
• Abnormal 12 lead ECG.
• History of tuberculosis.
• History of hepatitis or positive testing for HIV, hepatitis B surface antigen, hepatitis B surface antibodies, hepatitis B core antibodies, hepatitis C antibodies or syphilis.
• Any medical history of disease (ie, Gilbert's disease).
• Abnormal clinical laboratory test related to cardiac and skeletal muscle injury.
• Male subjects with partners currently pregnant; unwilling or unable to use a highly effective method of contraception
• Use of prescription or nonprescription drugs, vitaminic and dietary supplements within a specified duration.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

P-one Clinic, Keikokai Medical Corporation

Hachioji-shi, Tokyo, 192-0071, Japan

Location

Related Links

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

MeSH Terms

Interventions

1-(((2S,3S,4S)-3-ethyl-4-fluoro-5-oxopyrrolidin-2-yl)methoxy)-7-methoxyisoquinoline-6-carboxamide

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: October 18, 2016
• Study Start: August 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 5, 2018

Record last verified: 2018-10

Locations

JP (1)