Phase 1
Completed N=70
STUDY OF PF-07321332 IN HEALTHY PARTICIPANTS
Healthy Participants
Source: ClinicalTrials.gov NCT04756531 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) in PART-1: SAD — 2; 1; 1; 0 Participants
Summary
A Phase 1, double blind, sponsor open, single and multiple ascending dose study to evaluate safety, tolerability and pharmacokinetics of PF-07321332 in healthy participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) in PART-1: SAD |
2; 1; 1; 0; 1; 1 | — |
| PRIMARY Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-1: SAD |
2; 0; 0; 1; 0; 0 | — |
| PRIMARY Number of Participants With Laboratory Abnormalities in PART-1: SAD |
1; 2; 1; 2; 1; 1 | — |
| PRIMARY Number of Participants With TEAEs in PART-2:MAD |
4; 3; 3; 4; 2; 4 | — |
| PRIMARY Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-2: MAD |
0; 0; 1; 0; 0; 1 | — |
| PRIMARY Number of Participants With Laboratory Abnormalities in PART-2: MAD |
5; 2; 4; 5; 2; 3 | — |
| PRIMARY Area Under the Plasma Concentration-Time Profile From Time 0 to The Time of The Last Quantifiable Concentration (AUClast) of Tablet Formulation and Suspension in PART-3: rBA/FE |
3318; 2695 | — |
| PRIMARY Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Tablet Formulation and Suspension in PART-3: rBA/FE |
3513; 2958 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of Tablet Formulation and Suspension in PART-3: rBA/FE |
883.1; 497.8 | — |
| PRIMARY Total Percent Recovery of Drug-Related Material in Urine in PART-4: ME |
47.0; 2.6 | — |
| PRIMARY Total Percent Recovery of Drug-Related Material in Feces in PART-4: ME |
33.7; 1.6 | — |
| PRIMARY Total Percent Recovery of Drug-Related Material in Excreta (Urine and Feces Combined) in PART-4: ME |
80.7; 4.2; 84.9 | — |
| PRIMARY Number of Participants With TEAEs in PART-5: SE |
3; 3; 1; 1; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-5: SE |
1; 0; 1; 1 | — |
| PRIMARY Number of Participants With Laboratory Abnormalities in PART-5: SE |
1; 2 | — |
| SECONDARY Cmax of Plasma PF-07321332 in PART-1: SAD |
667.7; 674.4; 1538; 2882; 3323; 5086 | — |
| SECONDARY Time for Cmax (Tmax) of Plasma PF-07321332 in PART-1: SAD |
0.634; 1.00; 1.00; 2.75; 4.00; 2.00 | — |
| SECONDARY AUClast of Plasma PF-07321332 in PART-1: SAD |
2125; 3753; 10870; 27600; 28020; 64230 | — |
| SECONDARY AUCinf of PF-07321332 in PART-1: SAD |
2247; NA; 28220; 28640; 66760 | — |
| SECONDARY Dose Normalized Cmax (Cmax[dn]) of Plasma PF-07321332 in PART-1: SAD |
4.450; 1.349; 1.025; 11.53; 13.32; 6.782 | — |
| SECONDARY Dose Normalized AUCinf (AUCinf[dn]) of Plasma PF-07321332 in PART-1: SAD |
14.97; NA; 112.8; 114.2; 89.14 | — |
| SECONDARY Dose Normalized AUClast (AUClast[dn]) of Plasma PF-07321332 in PART-1: SAD |
14.15; 7.507; 7.247; 110.4; 112.0; 85.77 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) in PART-1: SAD |
190.6; NA; 87.98; 73.48; 181.9 | — |
| SECONDARY Apparent Clearance (CL/F) in PART-1: SAD |
66.83; NA; 8.865; 8.735; 11.22 | — |
| SECONDARY Terminal Half-Life (t1/2) of Plasma PF-07321332 in PART-1: SAD |
2.023; NA; 6.935; 6.005; 12.86 | — |
| SECONDARY Cmax of Plasma PF-07321332 in PART-2: MAD on Day 1, Day 5 and Day 10 |
1042; 2435; 3051; 1925; 2224; 4774 | — |
| SECONDARY Tmax of Plasma PF-07321332 in PART-2: MAD on Day 1, Day 5 and Day 10 |
1.75; 1.50; 2.00; 2.75; 1.00; 0.750 | — |
| SECONDARY Area Under the Plasma Concentration Time Profile From Time 0 to Time Tau (AUCtau) of Plasma PF-07321332 in PART-2: MAD on Day 1, Day 5 and Day 10 |
6017; 18700; 22610; 13130; 12570; 35560 | — |
| SECONDARY Cmax(dn) of Plasma PF-07321332 in PART-2: MAD on Day 1, Day 5 and Day 10 |
13.89; 9.755; 6.103; 7.698; 29.66; 19.10 | — |
| SECONDARY Dose Normalized AUCtau (AUCtau[dn]) of Plasma PF-07321332 in PART-2: MAD on Day 1, Day 5 and Day 10 |
80.19; 74.76; 45.23; 52.60; 167.7; 141.9 | — |
| SECONDARY Average Plasma Concentration Over the Dosing Interval (Cav) of Plasma PF-07321332 in PART-2: MAD on Day 5 and Day 10 |
1049; 2963; 3181; 2124; 1053; 3147 | — |
| SECONDARY Minimum Observed Concentration During the Dosing Interval (Cmin) of Plasma PF-07321332 in PART-2: MAD on Day 5 and Day 10 |
251.0; 1315; 1195; 707.3; 245.3; 1480 | — |
| SECONDARY Observed Accumulation Ratio for AUCtau (Rac) Plasma PF-07321332 in PART-2: MAD on Day 5 and Day 10 |
2.091; 1.901; 1.685; 1.937; 2.104; 2.022 | — |
| SECONDARY Observed Accumulation Ratio for Cmax (Rac,Cmax) of Plasma PF-07321332 in PART-2: MAD on Day 5 and Day 10 |
2.133; 1.959; 1.733; 1.909; 1.971; 2.101 | — |
| SECONDARY Peak-to-Trough Ratio (PTR) of Plasma PF-07321332 in PART-2: MAD on Day 5 and Day 10 |
8.857; 3.635; 4.430; 5.194; 8.383; 3.462 | — |
| SECONDARY CL/F of Plasma PF-07321332 in PART-2:MAD on Day 5 and Day 10 |
5.966; 7.032; 13.11; 9.814; 5.933; 6.617 | — |
| SECONDARY Vz/F of Plasma PF-07321332 in PART-2: MAD on Day 10 |
66.43; 63.40; 142.4; 65.04 | — |
| SECONDARY t1/2 of of Plasma PF-07321332 in PART-2: MAD on Day 10 |
7.955; 6.795; 8.047; 5.163 | — |
| SECONDARY Amount Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau) in PART-2: MAD on Day 10 |
47.83; 129.9; 116.5; 135.4 | — |
| SECONDARY Percent of Dose Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau%) in PART-2: MAD on Day 10 |
63.79; 51.81; 23.35; 54.20 | — |
| SECONDARY Renal Clearance (CLr) in PART-2: MAD on Day 10 |
3.782; 3.433; 2.934; 5.028 | — |
| SECONDARY AUClast of Plasma PF-07321332 of Tablet Formulation Under Fed Condition and Fasted Condition in PART-3: rBA/FE |
2695; 4012 | — |
| SECONDARY AUCinf of Plasma PF-07321332 of Tablet Formulation Under Fed Condition and Fasted Condition in PART-3: rBA/FE |
2958; 4256 | — |
| SECONDARY Cmax of Plasma PF-07321332 of Tablet Formulation Under Fed Condition and Fasted Condition in PART-3: rBA/FE |
497.8; 1219 | — |
| SECONDARY Cmax(dn) of Plasma PF-07321332 in PART-3: rBA/FE |
3.533; 1.992; 4.874 | — |
| SECONDARY Tmax of Plasma PF-07321332 in PART-3: rBA/FE |
1.00; 1.00; 1.75 | — |
| SECONDARY AUClast(dn) of Plasma PF-07321332 in PART-3: rBA/FE |
13.27; 10.78; 16.03 | — |
| SECONDARY AUCinf(dn) of Plasma PF-07321332 in PART-3: rBA/FE |
14.06; 11.82; 17.03 | — |
| SECONDARY CL/F of Plasma PF-07321332 in PART-3: rBA/FE |
71.07; 84.56; 58.70 | — |
| SECONDARY Vz/F of Plasma PF-07321332 in PART-3: rBA/FE |
493.7; 1004; 151.0 | — |
| SECONDARY t1/2 of Plasma PF-07321332 in PART-3: rBA/FE |
5.626; 9.086; 1.854 | — |
| SECONDARY Number of Participants With TEAEs in PART-3: rBA/FE |
3; 3; 1; 2; 1; 0 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities in PART-3: rBA/FE |
1; 2; 0 | — |
| SECONDARY Cmax of Plasma PF-07321332 in PART-4: ME |
4068 | — |
| SECONDARY Tmax of Plasma PF-07321332 in PART-4: ME |
2.00 | — |
| SECONDARY AUClast of Plasma PF-07321332 in PART-4: ME |
32960 | — |
| SECONDARY AUCinf of Plasma PF-07321332 in PART-4: ME |
33470 | — |
| SECONDARY CL/F of Plasma PF-07321332 in PART-4: ME |
8.968 | — |
| SECONDARY Vz/F of Plasma PF-07321332 in PART-4: ME |
115.8 | — |
| SECONDARY t1/2 of Plasma PF-07321332 in PART-4: ME |
9.485 | — |
| SECONDARY Number of Participants With TEAEs in PART-4: ME |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities in PART-4: ME |
3 | — |
| SECONDARY Cmax of Plasma PF-07321332 in PART-5: SE |
15940 | — |
| SECONDARY Tmax of Plasma PF-07321332 in PART-5: SE |
5.00 | — |
| SECONDARY AUClast of Plasma PF-07321332 in PART-5: SE |
188200 | — |
| SECONDARY AUCinf of Plasma PF-07321332 in PART-5: SE |
188800 | — |
| SECONDARY t1/2 of Plasma PF-07321332 in PART-5: SE |
7.450 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male or female subjects between ages of 18-60 years. Male only in part-4.
- Body Mass Index (BMI) of 17.5 to 30.5kg/m2; and a total body weight >50kg (110lbs)
- Japanese subjects who have four Japanese biologic grandparents born in Japan
Exclusion Criteria
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, intestinal resection).
- Positive test result for SARS-CoV-2 infection at the time of screening or Day-1.
- Have received COVID-19 vaccine within 7 days before screening or have received only one of the 2 required doses of COVID-19 vaccine
- Use of tobacco or nicotine containing products in excess of the equivalents of 5 cigarettes per day or 2 chews of tobacco per day
Data sourced from ClinicalTrials.gov (NCT04756531). 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.