Phase 1
N=6
A Study to Understand How the Study Medicine (PF-07081532) is Processed and Eliminated in Healthy Men
Healthy Participants
Bottom Line
View on ClinicalTrials.gov: NCT05652647 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Total Recovery of Radioactivity in Urine, Feces and Both Routes Combined, as Percentage of Orally Administered Radioactive Dose of [14C]PF-07081532 — 4.7; 78.6; 83.4 Percentage of radioactive dose
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Oral [14C]PF-07081532 (Drug); Oral PF-07081532 and IV [14C]PF-07081532 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Pfizer
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Recovery of Radioactivity in Urine, Feces and Both Routes Combined, as Percentage of Orally Administered Radioactive Dose of [14C]PF-07081532 |
4.7; 78.6; 83.4 | — |
| PRIMARY Relative Abundance of [14C]PF-07081532 and Its Metabolites in Plasma After A Single Oral Dose of [14]PF-07081532 in Period 1 |
1.2; 8.8; 0.4; 0.6; 9.1; 79.3 | — |
| PRIMARY Relative Abundance of [14C]PF-07081532 and Its Metabolites in Urine and Feces After A Single Oral Dose of [14]PF-07081532 in Period 1 |
0.1; 0.03; 0.2; 0.04; 4.33; 3.89 | — |
| SECONDARY Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Total [14C] After A Single Oral Dose of [14C]PF-07081532 in Period 1 |
74360 | — |
| SECONDARY AUClast of PF-07081532 After A Single Oral Dose of [14]PF-07081532 in Period 1 |
49380 | — |
| SECONDARY Plasma Maximum Observed Concentration (Cmax) of Total [14C] After A Single Oral Dose of [14C]PF-07081532 in Period 1 |
2934 | — |
| SECONDARY Plasma Cmax of PF-07081532 After A Single Oral Dose of [14C]PF-07081532 in Period 1 |
2874 | — |
| SECONDARY Plasma Time to Reach Cmax (Tmax) of Total [14C] and PF-07081532 After A Single Oral Dose of [14C]PF-07081532 in Period 1 |
4.93; 3.93 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve to Infinity (AUCinf) of Total [14C] After A Single Oral Dose of [14C]PF-07081532 in Period 1 |
76050 | — |
| SECONDARY AUCinf of PF-07081532 After A Single Oral Dose of [14C]PF-07081532 in Period 1 |
51370 | — |
| SECONDARY Plasma Elimination Half Life (t1/2) of Total [14C] and PF-07081532 After A Single Oral Dose of [14C]PF-07081532 in Period 1 |
65.20; 19.42 | — |
| SECONDARY Apparent Clearance of Drug From Plasma (CL/F) of PF-07081532 After A Single Oral Dose of [14C]PF-07081532 in Period 1 |
0.5851 | — |
| SECONDARY Plasma Apparent Volume of Distribution (Vz/F) of PF-07081532 After A Single Oral Dose of [14C]PF-07081532 in Period 1 |
16.13 | — |
| SECONDARY Plasma AUClast of [14C]PF-07081532 Following Intravenous (IV) Administration of [14C]PF-07081532 in Period 2 |
185.9 | — |
| SECONDARY Dose-Normalized Plasma AUClast (AUClast(dn) of [14C]PF-07081532 Following IV Administration of [14C]PF-07081532 in Period 2 |
1831 | — |
| SECONDARY Plasma Cmax of [14C]PF-07081532 Following IV Administration of [14C]PF-07081532 in Period 2 |
23.20 | — |
| SECONDARY Dose-Normalized Plasma Cmax (Cmax (dn)) of [14C]PF-07081532 Following IV Administration of [14C]PF-07081532 in Period 2 |
228.5 | — |
| SECONDARY Plasma Tmax of [14C]PF-07081532 Following IV Administration of [14C]PF-07081532 in Period 2 |
0.250 | — |
| SECONDARY Plasma AUCinf of [14C]PF-07081532 Following IV Administration of [14C]PF-07081532 in Period 2 |
186.9 | — |
| SECONDARY Dose-Normalized Plasma AUCinf (AUCinf(dn)) of [14C]PF-07081532 Following IV Administration of [14C]PF-07081532 in Period 2 |
1844 | — |
| SECONDARY Plasma t1/2 of [14C]PF-07081532 Following IV Administration of [14C]PF-07081532 in Period 2 |
21.02 | — |
| SECONDARY Plasma Clearance (CL) of [14C]PF-07081532 Following IV Administration of [14C]PF-07081532 in Period 2 |
0.5420 | — |
| SECONDARY Plasma Steady-State Volume of Distribution (Vss) of [14C]PF-07081532 Following IV Administration of [14C]PF-07081532 in Period 2 |
10.70 | — |
| SECONDARY Plasma Mean Residence Time (MRT) of [14C]PF-07081532 Following IV Administration of [14C]PF-07081532 in Period 2 |
19.77 | — |
| SECONDARY Absolute Oral Bioavailability (F) of PF-07081532 in Period 2 |
90.79 | — |
| SECONDARY Fraction Absorbed (Fa) of PF-07081532 |
79.91 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
4; 2; 2; 1; 0; 0 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormality (Without Regard to Baseline Abnormality) |
1; 0 | — |
| SECONDARY Number of Participants With Post-Baseline Vital Signs Data Meeting Pre-Defined Criteria |
0; 1 | — |
| SECONDARY Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Defined Criteria |
0; 0 | — |
Summary
The purpose of this clinical trial is to learn about how much PF-07081532 will be taken up and processed by healthy male participants. The study consists of two parts, called study periods. In Period 1, participants will take one dose of PF-07081532 by mouth. In Period 2, participants will take one dose by mouth and one dose as an injection through a vein at the study clinic.
In Period 1, participants will stay at the clinic site for up to 21 days. In Period 2, they will stay at the clinic site for 7 days. During their stays, participants will have their blood, urine, and feces collected by the study doctors several times. We will measure the level of PF-07081532 in participants' blood, urine, and feces samples. This will help us know how much the study medicine is getting taken in by the body. At the end of the study, participants will be contacted by phone to check in. Participants will be involved in this study for about 12 weeks.
Eligibility Criteria
Key Eligibility criteria for this study include, but are not limited to the following:
Inclusion criteria
Healthy Male participants must be 18 to 60 years of age, inclusive.
Overtly healthy as determined by medical evaluation including medical history, physical examination, blood pressure and pulse rate measurement, standard 12-lead ECG, and laboratory tests.
BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
Exclusion criteria
History of irregular bowel movements (eg, irritable bowel syndrome, frequent episodes of diarrhea, or constipation defined by less than 1 bowel movement on average per 2 days) or lactose intolerance
Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
Previous administration with an investigational product (drug or vaccine) within 90 days (or as determined by the local requirement) preceding the first dose of study intervention used in this study.
Total 14C radioactivity measured in plasma exceeding 11 mBq/mL.
Data sourced from ClinicalTrials.gov (NCT05652647). 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.