Phase 1
N=30
Renal Impairment Study of PF-06700841
Healthy Volunteer · Renal Impairment
Bottom Line
View on ClinicalTrials.gov: NCT04260464 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function — 303.2; 275.2; 341.8; 260.3 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PF-06700841 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function |
303.2; 275.2; 341.8; 260.3 | — |
| PRIMARY Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function |
2013; 1796; 2652; 1274 | — |
| PRIMARY Cmax of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function |
250.4; 141.0; 172.1; 187.1 | — |
| PRIMARY AUCinf of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function |
7756; 1739; 3984; 2515 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
2; 0; 1; 3; 0; 0 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality |
2; 0; 0; 0; 1; 0 | — |
| SECONDARY Number of Participants With Post-baseline Vital Sign Abnormalities |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Post-baseline Electrocardiogram (ECG) Abnormalities |
2; 0; 1; 3; 0; 0 | — |
Summary
The purpose of this study is to characterize the effect of kidney impairment on the blood concentrations of PF-06700841 and its major metabolite. Findings from this study will be used to develop dosing recommendations so that the dose and/or dosing interval may be adjusted appropriately in the presence of kidney disease.
Eligibility Criteria
Inclusion Criteria
- Male or female participants who are between the ages of 18 and 75 years, inclusive, at the Screening visit.
- Body mass index (BMI) of ≥17.5 to ≤40 kg/m2; and a total body weight >50 kg.
- Normal, Severe, Moderate and Mild renal function at 2 Screening visits.
- Stable drug regimen
Exclusion Criteria
- Renal transplant recipients.
- Urinary incontinence without catheterization.
- Subjects with clinically significant infections within the past 6 months prior to first dose of study drug, evidence of active or chronic infection requiring oral treatment within 4 weeks prior to first dose
- Known history of pulmonary embolism or recurrent deep vein thrombosis
- Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection).
Data sourced from ClinicalTrials.gov (NCT04260464). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.