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Renal Impairment Study of PF-07321332 Boosted With Ritonavir in Adult Participants With Renal Impairment and in Healthy Participants With Normal Renal Function.
Phase 1 trial testing PF-07321332/ritonavir in Renal Impairment in 35 participants. Completed in 7 October 2021.
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 35 |
| Start date | 15 June 2021 |
| Primary completion | 7 October 2021 |
| Estimated completion | 7 October 2021 |
| Sites | 5 locations across United States |
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Adults 18 to 75, any sex, with Renal Impairment. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
| Group | Value | 95% CI |
|---|---|---|
| Part 1: Normal Renal Function | 1600 | ± 31 |
| Part 1: Mild Renal Impairment | 2077 | ± 29 |
| Part 1: Moderate Renal Impairment | 2210 | ± 17 |
| Part 2: Severe Renal Impairment | 2369 | ± 38 |
AUCinf was calculated by AUClast + (Clast/kel). AUClast was the area under the plasma concentration-time profile from time 0 to the time of Clast. Clast was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
| Group | Value | 95% CI |
|---|---|---|
| Part 1: Normal Renal Function | 14460 | ± 20 |
| Part 1: Mild Renal Impairment | 17910 | ± 30 |
| Part 1: Moderate Renal Impairment | 27110 | ± 27 |
| Part 2: Severe Renal Impairment | 44040 | ± 33 |
Total amount of unchanged drug excreted in the urine over 48 hours.
| Group | Value | 95% CI |
|---|---|---|
| Part 1: Normal Renal Function | 31.20 | ± 45 |
| Part 1: Mild Renal Impairment | 42.65 | ± 23 |
| Part 1: Moderate Renal Impairment | 30.83 | ± 56 |
| Part 2: Severe Renal Impairment | 18.46 | ± 50 |
Renal clearance was calculated as total amount of unchanged drug excreted in the urine over 48 hours (Ae48) divided by area under the plasma concentration-time profile from time 0 to 48 hours post dose.
| Group | Value | 95% CI |
|---|---|---|
| Part 1: Normal Renal Function | 2.180 | ± 50 |
| Part 1: Mild Renal Impairment | 2.395 | ± 33 |
| Part 1: Moderate Renal Impairment | 1.154 | ± 71 |
| Part 2: Severe Renal Impairment | 0.4398 | ± 73 |
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was any untoward medical occurrence that, at any dose resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent was considered serious; other important medical event
| Group | Value | 95% CI |
|---|---|---|
| Part 1: Normal Renal Function | 2 | |
| Part 1: Mild Renal Impairment | 1 | |
| Part 1: Moderate Renal Impairment | 1 | |
| Part 2: Severe Renal Impairment | 5 |
| Group | Value | 95% CI |
|---|---|---|
| Part 1: Normal Renal Function | 0 | |
| Part 1: Mild Renal Impairment | 0 | |
| Part 1: Moderate Renal Impairment | 0 | |
| Part 2: Severe Renal Impairment | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Part 1: Normal Renal Function | 0 | |
| Part 1: Mild Renal Impairment | 0 | |
| Part 1: Moderate Renal Impairment | 0 | |
| Part 2: Severe Renal Impairment | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Part 1: Normal Renal Function | 0 | |
| Part 1: Mild Renal Impairment | 0 | |
| Part 1: Moderate Renal Impairment | 0 | |
| Part 2: Severe Renal Impairment | 0 |
The hematology, clinical chemistry and urinalysis tests were included in the laboratory examination. The criteria for hematology evaluation included hemoglobin less than (\<) 0.8\*lower limit of normal (LLN), hematocrit \<0.8\*LLN, erythrocytes \<0.8\*LLN, erythrocyte mean corpuscular hemoglobin \<0.9\*LLN and lymphocytes \<0.8\*LLN. The criteria for clinical chemistry evaluation included neutrophils \<0.8\*LLN, eosinophils greater than (\>) 1.2\* upper limit of normal (ULN), monocytes \>1.2\*ULN, urea nitrogen \>1.3\*ULN, creatinine \>1.3\*ULN, urate \>1.2\*ULN, potassium \>1.1\*ULN and bicar
| Group | Value | 95% CI |
|---|---|---|
| Part 1: Normal Renal Function | 5 | |
| Part 1: Mild Renal Impairment | 4 | |
| Part 1: Moderate Renal Impairment | 8 | |
| Part 2: Severe Renal Impairment | 8 |
Supine blood pressure, pulse rate, respiratory rate and oral temperature were evaluated in vital signs examination. Clinical significance was judged by investigator.
| Group | Value | 95% CI |
|---|---|---|
| Part 1: Normal Renal Function | 0 | |
| Part 1: Mild Renal Impairment | 0 | |
| Part 1: Moderate Renal Impairment | 0 | |
| Part 2: Severe Renal Impairment | 1 |
A complete physical examination included, at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. Clinical significance was judged by investigator.
| Group | Value | 95% CI |
|---|---|---|
| Part 1: Normal Renal Function | 0 | |
| Part 1: Mild Renal Impairment | 1 | |
| Part 1: Moderate Renal Impairment | 0 | |
| Part 2: Severe Renal Impairment | 0 |
A standard 12-lead ECGs utilizing limb leads (with a 10 second rhythm strip) were collected using an ECG machine that automatically calculates the heart rate and measures PR, QT, and QTc intervals and QRS complex. All scheduled ECGs were performed after the participant had rested quietly for at least 5 minutes in a supine position. Clinical significance was judged by investigator.
| Group | Value | 95% CI |
|---|---|---|
| Part 1: Normal Renal Function | 0 | |
| Part 1: Mild Renal Impairment | 0 | |
| Part 1: Moderate Renal Impairment | 0 | |
| Part 2: Severe Renal Impairment | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Part 1: Normal Renal Function | 341.9 | ± 35 |
| Part 1: Mild Renal Impairment | 438.0 | ± 30 |
| Part 1: Moderate Renal Impairment | 785.6 | ± 33 |
| Part 2: Severe Renal Impairment | 1213 | ± 33 |
| Group | Value | 95% CI |
|---|---|---|
| Part 1: Normal Renal Function | 99.10 | ± 35 |
| Part 1: Mild Renal Impairment | 112.8 | ± 55 |
| Part 1: Moderate Renal Impairment | 179.1 | ± 108 |
| Part 2: Severe Renal Impairment | 694.2 | ± 42 |
Tmax was observed directly from data as time of first occurrence.
| Group | Value | 95% CI |
|---|---|---|
| Part 1: Normal Renal Function | 2.000 | 1.00 – 4.00 |
| Part 1: Mild Renal Impairment | 2.000 | 1.00 – 3.00 |
| Part 1: Moderate Renal Impairment | 2.500 | 1.00 – 6.00 |
| Part 2: Severe Renal Impairment | 3.000 | 1.00 – 6.05 |
Time frame: Part 1 and Part 2: Day -1 up to maximum of 35 days after last dose (maximum of 38 days). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Part 1: Normal Renal Funct… | Part 1: Mild Renal Impairm… | Part 1: Moderate Renal Imp… | Part 2: Severe Renal Impai… |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | — | — | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — | — | — |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Reaction | System | Part 1: Normal Renal Funct… | Part 1: Mild Renal Impairm… | Part 1: Moderate Renal Imp… | Part 2: Severe Renal Impai… |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | — | — | — | — |
| Asthenia | General disorders | — | — | — | — |
| Dysgeusia | Nervous system disorders | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — | — | — |
| Bradycardia | Cardiac disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Hyperkalaemia | Metabolism and nutrition disorders | — | — | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — | — | — |
| Metabolic acidosis | Metabolism and nutrition disorders | — | — | — | — |
| Agitation | Psychiatric disorders | — | — | — | — |
| Dermatitis | Skin and subcutaneous tissue disorders | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — |
Most-reported serious reactions: Pneumonia, Acute kidney injury, Pulmonary oedema.
Data from ClinicalTrials.gov NCT04909853 adverse events section.
This is a Phase 1, non-randomized, open-label, 2-part study to investigate the effect of renal impairment on the pharmacokinetics (PK), safety and tolerability of a single oral dose of PF-07321332 in combination with the PK boosting agent ritonavir. Participants will be selected and categorized into normal renal function or renal impairment groups based on their estimated glomerular filtration rate. Part 1: will be conducted in approximately 24 participants (approximately 8 per group) with stable mild or moderate renal impairment and a control group of participants with normal renal function. Part 2 will be conducted in approximately 8 participants with stable severe renal impairment.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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