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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 May 2024 |
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Main ID: |
NCT06397144 |
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Date of registration:
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29/04/2024 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study on 2 Different Combination Tablets of Nirmatrelvir Plus Ritonavir to Compare Them With Marketed Paxlovid in Healthy Participants
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Scientific title:
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A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, CROSSOVER STUDY TO DETERMINE THE BE OF NIRMATRELVIR FOLLOWING ORAL ADMINISTRATION OF FDC TABLETS RELATIVE TO THE PAXLOVID® COMMERCIAL TABLETS IN HEALTHY ADULT PARTICIPANTS UNDER FASTED CONDITIONS |
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Date of first enrolment:
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February 14, 2025 |
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Target sample size:
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28 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT06397144 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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Phase 1
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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1-800-718-1021 |
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Email:
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ClinicalTrials.gov_Inquiries@pfizer.com |
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Affiliation:
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Participants who are overtly healthy as determined by medical evaluation including
medical history, physical examination, laboratory tests, and standard 12-lead ECG
(electrocardiogram).
- Participants who are willing and able to comply with all scheduled visits, treatment
plan, laboratory tests, lifestyle considerations, and other study procedures.
- Female participants of childbearing potential must have a negative pregnancy test at
screening and on Day -1.
- BMI (Body Mass Index) of 16-32 kg/m2; and a total body weight >50 kg (110 lb).
- Capable of giving signed informed consent, which includes compliance with the
requirements and restrictions listed in the ICD (Informed consent Document) and in
this protocol.
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).
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- History of HIV (Human Immunodeficiency Virus) infection, Hepatitis B, or Hepatitis C;
positive testing for HIV, HBsAg (Hepatitis B surface Antigen), HBcAb (Hepatitis B core
Antibody) or HCVAb (Hepatitis C Virus Antibody). Hepatitis B vaccination is allowed.
- Any medical or psychiatric condition including recent (within the past year) or active
suicidal ideation/behavior or laboratory abnormality or other conditions that may
increase the risk of study participation or, in the investigator's judgment, make the
participant inappropriate for the study.
- 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.
- Participants 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Healthy Participants
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Biological Availability
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Intervention(s)
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Drug: Nirmatrelvir/ritonavir
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Drug: Paxlovid
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Primary Outcome(s)
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Area under curve (AUC) from time zero to 48 hours post dose (nirmatrelvir)
[Time Frame: 0 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours]
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Peak plasma concentration (Cmax) for nirmatrelvir
[Time Frame: 0 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours]
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Secondary Outcome(s)
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Cmax for ritonavir
[Time Frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours]
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AUC from time zero to 48 hours post dose (ritonavir)
[Time Frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours]
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Number of Participants With Clinically Notable Abnormality in physical examination
[Time Frame: Baseline (Day 0) up to day 3 of treatment period 4]
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Number of Participants With Clinically Notable Vital Signs
[Time Frame: Baseline (Day 0) up to day 3 of treatment period 4]
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Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
[Time Frame: Baseline (Day 0) up to 28 days after last dose of study medication]
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Number of Participants With Clinically Notable Changes in Clinical laboratory results
[Time Frame: Baseline (Day 0) up to day 3 of treatment period 4]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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