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- Breath alcohol test at Screening and Day -1 must be negative.
- Body mass index (BMI) of ≥ 17.5 to ≤ 40.0 kg/m2; and a total body weight >50 kg (110 lb).
Additional inclusion criteria for subjects with renal impairment:
- Meet the following eGFR criteria during the screening period based on the MDRD equation:
- Severe renal impairment: eGFR <30 mL/min, but not requiring hemodialysis.
- Moderate renal impairment (Part 2 only): eGFR ≥30 mL/min and <60 mL/min.
- Any form of renal impairment except acute nephritic syndrome (subjects with history of previous nephritic syndrome but in remission can be included).
- Stable concomitant drug regimen.
- Renal transplant recipients.
- Urinary incontinence without catheterization.
- Subjects with clinically significant infections within the past 3 months (for example,
those requiring hospitalization, or as judged by the Investigator), evidence of any
infection (including influenza) within the past 7 days prior to baseline, history of
disseminated herpes simplex infection or recurrent or disseminated herpes zoster.
- Subjects with a malignancy or with a history of malignancy, with the exception of
adequately treated or excised non-metastatic basal cell or squamous cell cancer of the
skin or cervical carcinoma in situ.
- History of or current positive results for human immunodeficiency virus, Hepatitis B,
Hepatitis C.
Additional exclusion criteria for subjects with renal impairment:
- Subjects requiring hemodialysis and peritoneal dialysis.
- Screening BP ≥ 180 mm Hg (systolic) or ≥ 110 mm Hg (diastolic).
- Screening supine 12-lead ECG demonstrating QTcF >470 msec or a QRS interval >120 msec.
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| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title ICMJE | A Renal Impairment Study for PF-04965842 | ||||
| Official Title ICMJE | A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-04965842 IN SUBJECTS WITH RENAL IMPAIRMENT AND IN HEALTHY SUBJECTS WITH NORMAL RENAL FUNCTION | ||||
| Brief Summary | This study is a phase 1 non-randomized, open-label, single-dose, parallel-group study of PF 04965842 in subjects with severe renal impairment and subjects without renal impairment (Part 1) and in subjects with moderate renal impairment (Part 2). | ||||
| Detailed Description | This is a Phase 1 non randomized, open label, single dose, parallel cohort, multisite study to investigate the effect of renal impairment on the pharmacokinetics, safety and tolerability of PF-04965842 after a single 200 mg oral dose. Subjects will be selected and categorized into normal renal function or renal impairment groups based on their estimated glomerular filtration rate. Part 1: A total of approximately16 subjects will be enrolled; approximately 8 subjects with severe renal impairment and approximately 8 with normal renal function. After statistical evaluation of results from Part 1, Part 2 may be conducted and approximately 8 subjects with moderate renal impairment will be enrolled. The total duration of participation from the Screening Visit to Day 4 will be a maximum of 31 days and from the Screening Visit to Follow-up Contact/Visit will be a maximum of 67 days. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 1 | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Parallel Assignment Intervention Model Description: Part 1 will be conducted. The 8 subjects from the renal impaired group will be recruited before recruiting the 8 subjects without renal impairment function in Part 1. After statistical evaluation of results from Part 1, Part 2 may be conducted. Masking: None (Open Label)Primary Purpose: Basic Science | ||||
| Condition ICMJE | Renal Impairment | ||||
| Intervention ICMJE | Drug: PF-04965842
PF 04965842 is a janus kinase (JAK) 1 inhibitor that is currently being developed for the treatment of atopic dermatitis (AD). | ||||
| Study Arms ICMJE | Experimental: PF-04965842
PF 04965842 is an oral selevtive janus kinase (JAK) 1 inhibitor Intervention: Drug: PF-04965842 | ||||
| Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE | 23 | ||||
| Original Estimated Enrollment ICMJE | 32 | ||||
| Actual Study Completion Date ICMJE | November 5, 2019 | ||||
| Actual Primary Completion Date | November 5, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Additional inclusion criteria for subjects with renal impairment:
Exclusion Criteria:
Additional exclusion criteria for subjects with renal impairment:
| ||||
| Sex/Gender ICMJE |
| ||||
| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Belgium, United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03660241 | ||||
| Other Study ID Numbers ICMJE | B7451021 2018-002865-20 ( EudraCT Number ) | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
| ||||
| IPD Sharing Statement ICMJE |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
| ||||
| PRS Account | Pfizer | ||||
| Verification Date | December 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||