Phase 1
Completed N=23
A Renal Impairment Study for PF-04965842
Source: ClinicalTrials.gov NCT03660241 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) for PF-04965842 — 1174; 1626; 1164 nanogram per milliliter (ng/mL)
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) for PF-04965842 |
1174; 1626; 1164 | — |
| PRIMARY Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-04965842 |
4827; 8828; 5855 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) for PF-06471658 (M1) |
193.7; 192.8; 325.0 | — |
| PRIMARY Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06471658 (M1) |
872.6; 1346; 2505 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) for PF-07055087 (M2) |
241.3; 331.6; 429.3 | — |
| PRIMARY Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-07055087 (M2) |
1476; 3981; 8433 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
1; 1; 0; 0; 1; 0 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) |
6; 6; 8 | — |
| SECONDARY Number of Participants With Clinically Significant Vital Sign Values |
0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Values |
0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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 470 msec or a QRS interval >120 msec.
Data sourced from ClinicalTrials.gov (NCT03660241). 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. Informational only — not medical advice.