Phase 1
N=23
A Renal Impairment Study for PF-04965842
Renal Impairment
Bottom Line
View on ClinicalTrials.gov: NCT03660241 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Maximum Observed Plasma Concentration (Cmax) for PF-04965842 — 1174; 1626; 1164 nanogram per milliliter (ng/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PF-04965842 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Nov 2019
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 | — |
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).
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.