Clinical trial NCT05580003: A Study to Learn Safety and Blood Levels of PF-07817883 in Healthy People
Official title: COVID-19: A MULTIPART, PHASE 1 STUDY WITH RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, SINGLE- AND MULTIPLE-DOSE ESCALATION TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-07817883 AND OPTIONAL OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE RELATIVE BIOAVAILABILITY AND FOOD EFFECT OF SOLID ORAL FORMULATION AND OPTIONAL OPEN-LABEL, NON-RANDOMIZED STUDY TO EVALUATE METABOLISM AND EXCRETION OF PF-07817883 AND OPTIONAL RANDOMIZED, OPEN-LABEL STUDY TO ASSESS THE EFFECT OF PF-07817883 ON PHARMACOKINETICS OF MIDAZOLAM IN HEALTHY ADULT PARTICIPANTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Oral Antiviral
COVID-19
Protease Inhibitor
Mpro
PF-07817883
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-10-14
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: PART-1 and -2 are a randomized, double-blind, sponsor-open, placebo-controlled trial to evaluate safety, tolerability and PK of single and multiple escalating oral doses of PF 07817883 in healthy adult participants, respectively. PART-1 is crossover while PART-2 is parallel cohort study design. PART-2 of the study may also evaluate the safety, tolerability and PK in Japanese and Chinese participants. PART-3 is a randomized, open-label, cross-over, study to evaluate relative bioavailability and food effect of up to 2 new PF 07817883 oral formulations. PART-4 is an open label, non-randomized, single period cohort to evaluate the metabolism and excretion of PF 07817883. PART-5 is an open-label, randomized, cross-over cohort to evaluate the effect of steady state PF-07817883 on PK of midazolam in healthy participants. PART-6 is a sponsor-open, randomized, 3-treatment, 3-period, cross over study to evaluate safety, tolerability, and PK of PF 07817883 at supratherapeutic exposure.
Primary purpose: OTHER

Brief summary: The purpose of this clinical trial is to learn if the study medicine (called PF-07817883) is safe and how it goes in and out of the body in healthy people. PF-07817883 is for the potential treatment of COVID-19. Participants will take PF-07817883 by mouth up to 2 times a day. This study may also evaluate how much PF-07817883 gets into the body when taken as pill. We may study if people's diets can affect this study medicine. We may also examine how PF-07817883 is processed and removed by the human body. Finally, we may look into if PF-07817883 has potential to interact with midazolam.

Detailed description: Combined 6-part study. Part-1: Single Ascending dose Part-2: Multiple Ascending Dose Part-3: Relative bioavailability and food effect Part-4: Metabolism and Excretion Part-5: Drug-drug interaction with midazolam Part-6: Supratherapeutic exposure Part-1,2 and 6 are double blind, sponsor open and Part-3,4 and 5 are open label study.

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). A body weight of \>45 kg may be considered in selected cases.
* Japanese subjects who have four Japanese biologic grandparents born in Japan
* Chinese participants who were born in mainland China and both parents are of the Chinese descent.

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
* Use of prescription or nonprescription drugs and dietary and herbal supplements within 28 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.

Primary outcomes:
measure: Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 days)
measure: Part 1: Number of Participants With Laboratory Test Abnormalities
timeFrame: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 days)
measure: Part 1: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
timeFrame: Up to Day 2 of each period
measure: Part 1: Number of Participants With Electrocardiogram (ECG) Abnormalities
timeFrame: Up to Day 2 of each period
measure: Part 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 days)
measure: Part 2: Number of Participants With Laboratory Test Abnormalities
timeFrame: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 days)
measure: Part 2: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
timeFrame: Up to Day 12
measure: Part 2: Number of Participants With Electrocardiogram (ECG) Abnormalities
timeFrame: Up to Day 12
measure: Part 3:Ratio Based on Area Under Plasma Concentration Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) and Area Under Concentration-Time Curve From Time 0 Extrapolated to Infinite Time (AUCinf) of Oral Formulation and Suspension
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
measure: Part 3: Ratio Based on Maximum Observed Concentration (Cmax) of Oral Formulation and Suspension
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
measure: Part 4: Percentage of Total Dose Administered Recovered in Urine
timeFrame: Up to 144 hours post-dose
measure: Part 4: Percentage of Total Dose Administered Recovered in Feces
timeFrame: Up to 144 hours post-dose
measure: Part 4: Percentage of Total Dose Administered Recovered in Urine and Feces
timeFrame: Up to 144 hours post-dose
measure: Part 5: Maximum Observed Concentration (Cmax) of Midazolam
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg arm
measure: Part 5: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of Midazolam
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg arm
measure: Part 6: Number of Participants With TEAEs
timeFrame: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 52 days)
measure: Part 6: Number of Participants With Laboratory Test Abnormalities
timeFrame: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 52 days)
measure: Part 6: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
timeFrame: Up to Day 6 of each period
measure: Part 6: Number of Participants According to Categorization of ECG Data
timeFrame: Up to Day 6 of each period
Secondary outcomes:
measure: Part 1: Maximum Observed Concentration (Cmax) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)
measure: Part 1: Time for Cmax (Tmax) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)
measure: Part 1: Area Under Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)
measure: Part 1: Dose Normalized Cmax (Cmax[dn]) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)
measure: Part 1: Dose Normalized AUClast (AUClast[dn]) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)
measure: Part 1: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)
measure: Part 1: Dose Normalized AUCinf (AUCinf[dn]) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)
measure: Part 1: Terminal Half-Life (t1/2) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)
measure: Part 1: Apparent Volume of Distribution (Vz/F) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)
measure: Part 1: Apparent Clearance (CL/F) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)
measure: Part 2: Maximum Observed Concentration (Cmax) of PF-07817883 on Days 1, 5 and 10
timeFrame: Day 1 and Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
measure: Part 2: Time for Cmax (Tmax) of PF-07817883 on Days 1, 5 and 10
timeFrame: Day 1 and Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
measure: Part 2: Area Under the Plasma Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) of PF-07817883 on Days 1, 5 and 10
timeFrame: Day 1 and Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose)
measure: Part 2: Concentration at 12 Hour Nominal Time Post-Dose (C12) of PF-07817883 on Days 5 and 10
timeFrame: 12 hours on Day 5 and Day 10
measure: Part 2: Dose Normalized Cmax (Cmax[dn]) of PF-07817883 on Days 1, 5 and 10
timeFrame: Day 1 and Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
measure: Part 2: Dose Normalized AUCtau (AUCtau[dn]) of PF-07817883 on Days 1, 5 and 10
timeFrame: Day 1 and Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose)
measure: Part 2: Average Concentration (Cav) of PF-07817883 on Days 5 and 10
timeFrame: Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose)
measure: Part 2: Observed Accumulation Ratio for AUCtau (Rac) of PF-07817883 on Days 5 and 10
timeFrame: Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose)
measure: Part 2: Observed Accumulation Ratio for Cmax (Rac,Cmax) of PF-07817883 on Days 5 and 10
timeFrame: Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
measure: Part 2: Peak-to-Trough Ratio (PTR) of PF-07817883 on Days 5 and 10
timeFrame: Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
measure: Part 2: Apparent Clearance (CL/F) of PF-07817883 on Days 5 and 10
timeFrame: Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
measure: Part 2: Apparent Volume of Distribution (Vz/F) of PF-07817883 on Day 10
timeFrame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
measure: Part 2: Terminal Half-Life (t1/2) of PF-07817883 on Day 10
timeFrame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
measure: Part 2: Amount Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau) of PF-07817883 on Day 10
timeFrame: Day 10 (0 to 12 hours)
measure: Part 2: Percent of Dose Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau%) of PF-07817883 on Day 10
timeFrame: Day 10 (0 to 12 hours)
measure: Part 2: Renal Clearance (CLr) of PF-07817883 on Day 10
timeFrame: Day 10 (0 to 12 hours)
measure: Part 3: Ratio Based on AUClast and AUCinf of Tablet Formulation Under Fed Condition and Fasted Condition
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
measure: Part 3: Ratio Based on Maximum Observed Concentration (Cmax) of Tablet Formulation Under Fed Condition and Fasted Condition
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
measure: Part 3: Time for Cmax (Tmax) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
measure: Part 3: Maximum Observed Concentration (Cmax) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
measure: Part 3: Area Under Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
measure: Part 3: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
measure: Part 3: Terminal Half-Life (t1/2) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
measure: Part 3: Apparent Clearance (CL/F) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
measure: Part 3: Apparent Volume of Distribution (Vz/F) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)
measure: Part 3: Number of Participants With TEAEs
timeFrame: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 days)
measure: Part 3: Number of Participants With Laboratory Test Abnormalities
timeFrame: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 days)
measure: Part 3: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
timeFrame: Up to Day 3 of each period
measure: Part 3: Number of Participants With ECG Abnormalities
timeFrame: Up to Day 3 of each period
measure: Part 4: Time for Cmax (Tmax) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)
measure: Part 4: Maximum Observed Concentration (Cmax) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)
measure: Part 4: Area Under Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)
measure: Part 4: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)
measure: Part 4: Terminal Half-Life (t1/2) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)
measure: Part 4: Apparent Clearance (CL/F) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)
measure: Part 4: Apparent Volume of Distribution (Vz/F) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)
measure: Part 4: Number of Participants With TEAEs
timeFrame: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 47 days)
measure: Part 4: Number of Participants With Laboratory Test Abnormalities
timeFrame: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 47 days)
measure: Part 4: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
timeFrame: Up to Day 11
measure: Part 4: Number of Participants With ECG Abnormalities
timeFrame: Up to Day 11
measure: Part 5: Number of Participants With TEAEs
timeFrame: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 65 days)
measure: Part 5: Number of Participants With Laboratory Test Abnormalities
timeFrame: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 65 days)
measure: Part 5: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
timeFrame: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 65 days)
measure: Part 5: Number of Participants With ECG Abnormalities
timeFrame: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 65 days)
measure: Part 5: Time for Cmax (Tmax) of Midazolam
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg arm
measure: Part 5: Area Under Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Midazolam
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg arm
measure: Part 5: Terminal Half-Life (t1/2) of Midazolam
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg arm
measure: Part 5: Apparent Clearance (CL/F) of Midazolam
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg arm
measure: Part 5: Apparent Volume of Distribution (Vz/F) of Midazolam
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg arm
measure: Part 6: Maximum Observed Concentration (Cmax) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose)
measure: Part 6: Time for Cmax (Tmax) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose)
measure: Part 6: Area Under Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose)
measure: Part 6: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose)
measure: Part 6: Terminal Half-Life (t1/2) of PF-07817883
timeFrame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: New Haven Clinical Research Unit
state: Connecticut
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit - Brussels
state: Bruxelles-capitale, Région DE
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: