Relative Bioavailability Study of PF-07321332/Ritonavir Oral Powder Relative to the Commercial Tablets in Healthy Participants

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT05263921
Collaborator
(none)
12
1
4
2.3
5.2

Study Details

Study Description

Brief Summary

The purpose of this study is to estimate the relative bioavailability of PF-07321332/ritonavir oral powder relative to the commercial tablet formulation under fasted condition in healthy adult participants. The study will also assess the effect of 3 different food vehicles on the relative bioavailability of the PF-07321332/ritonavir oral powder formulation as well as the safety, tolerability, and palatability of PF-07321332/ritonavir oral powder in healthy adult participants.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF PF-07321332/RITONAVIR ORAL POWDER IN 3 DIFFERENT DELIVERY VEHICLES RELATIVE TO THE COMMERCIAL PF-07321332/RITONAVIR TABLETS IN HEALTHY ADULT PARTICIPANTS UNDER FASTED CONDITIONS
Actual Study Start Date :
Mar 10, 2022
Actual Primary Completion Date :
May 19, 2022
Actual Study Completion Date :
May 19, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Treatment A: PF-07321332/ritonavir

PF-07321332 ritonavir

Drug: PF-07321332/ritonavir
Single oral dose of PF-07321332/ritonavir under fasted conditions

Experimental: Treatment B: PF-07321332/ritonavir

PF-07321332/ritonavir mixed with water

Drug: PF-07321332/ritonavir
Single oral dose of PF-07321332/ritonavir mixed with water under fasted conditions

Experimental: Treatment C: PF-07321332/ritonavir

PF-07321332/ritonavir mixed with applesauce

Drug: PF-07321332/ritonavir
Single oral dose of PF-07321332/ritonavir mixed with applesauce under fasted conditions

Experimental: Treatment D: PF-07321332/ritonavir

PF-07321332/ritonavir mixed with vanilla pudding

Drug: PF-07321332/ritonavir
Single oral dose of PF-07321332/ritonavir mixed with vanilla pudding under fasted conditions

Outcome Measures

Primary Outcome Measures

  1. Area under curve from time zero to 72 hours post dose [0 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours]

  2. Peak plasma concentration (Cmax) [0 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours]

Secondary Outcome Measures

  1. Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) [Baseline (Day 0) up to 28 days after last dose of study medication]

  2. Number of Participants With Notable Electrocardiogram (ECG) Values [Baseline (Day 0) up to day 4 of treatment period 4]

  3. Number of Participants With Clinically Notable Vital Signs [Baseline (Day 0) up to day 4 of treatment period 4]

  4. Number of Participants With Clinically Notable Changes in Clinical laboratory [Baseline (Day 0) up to day 4 of treatment period 4]

  5. Number of Participants With Clinically Notable Abnormality in physical examination [Baseline (Day 0) up to day 4 of treatment period 4]

  6. Palatability assessment of PF-07321332/ritonavir oral powder mixed with water/applesauce/vanilla pudding [1, 5, 10 and 20 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination (PE), laboratory tests, vital signs and standard 12 lead ECGs.

  • Body mass index (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:
  • Positive test result for SARS-CoV-2 infection at the time of Screening or Day -1.

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

  • Clinically relevant abnormalities requiring treatment (eg, acute myocardial infarction, unstable ischemic conditions, evidence of ventricular dysfunction, serious tachy or brady arrhythmias) or indicating serious underlying heart disease (eg, prolonged PR interval, cardiomyopathy, heart failure greater than New York Heart Association (NYHA) 1, underlying structural heart disease, Wolff Parkinson-White syndrome).

  • Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).

  • History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis B surface antibody (HCVAb). Hepatitis B vaccination is allowed.

  • Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.

  • Participant who have received a COVID-19 vaccine within 7 days before screening or admission, or who are to be vaccinated with a COVID-19 vaccine at any time during the study confinement period.

  • A positive urine drug test.

Contacts and Locations

Locations

Site City State Country Postal Code
1 New Haven Clinical Research Unit New Haven Connecticut United States 06511

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT05263921
Other Study ID Numbers:
  • C4671024
First Posted:
Mar 3, 2022
Last Update Posted:
Jul 1, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pfizer
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 1, 2022