AzTrials
AzTrials

HealthyPhase 1NCT06646042

A Study to Learn If the Study Medicine Called Carbamazepine Changes How the Body Processes the Other Study Medicine Ibuzatrelvir in Healthy Adults

A Phase 1 study testing ibuzatrelvir and carbamazepine ER in people with Healthy, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to estimate the effect of carbamazepine, a strong CYP3A4 inducer, on the pharmacokinetics (PK) of ibuzatrelvir in healthy participants. This study is seeking participants who: are male or female that are not of childbearing potential of 18 years of age or older are examined to be healthy… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
ibuzatrelvir and carbamazepine ER
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
28 Oct 2024to 17 Jan 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participants are eligible to be included in the study only if all of the following criteria apply:
  • -Male participants and female participants who are not of childbearing potential who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, pulse rate and standard 12 lead ECG

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • 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 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.
  • Subjects shown to carry or be positive for HLA-B*1502 or HLA-A*3101 (genotyping alleles/markers related to carbamazepine-associated hypersensitivity reactions, including SJS/TEN).
  • Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants <60 years; and ≥150/90 mm/Hg for participants ≥60 years old, following at least 5 minutes of supine rest. If systolic BP is ≥ 140 or 150 mm Hg (based on age) or diastolic ≥90 mm Hg, the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
  • An eGFR <60 mL/min/1.73m², as determined by the CKD-EPI equation using Screat calculated using the recommended formulas
  • Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF >450 ms, complete LBBB, signs of an acute or indeterminate- age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third- degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If QTcF exceeds 450 ms, or QRS exceeds 120 ms, the ECG should be repeated twice and the average of the 3 QTcF or QRS values used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding a participant.
  • Participants with ANY of the following abnormalities in clinical laboratory tests at screening and prior to dosing in each period, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary: ALT, AST, Bilirubin ≥1.5 x ULN. Participants with an elevated total bilirubin consistent with Gilberts Disease may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pfizer Clinical Research Unit - New Haven

    New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: A PHASE 1, OPEN-LABEL, FIXED SEQUENCE STUDY TO ESTIMATE THE EFFECT OF CARBAMAZEPINE ON THE PHARMACOKINETICS OF IBUZATRELVIR IN HEALTHY ADULT PARTICIPANTS

The purpose of this study is to estimate the effect of carbamazepine, a strong CYP3A4 inducer, on the pharmacokinetics (PK) of ibuzatrelvir in healthy participants.

This study is seeking participants who:

Read more
  • are male or female that are not of childbearing potential of 18 years of age or older
  • are examined to be healthy

The study will consist of two treatments: (1) a single oral dose of ibuzatrelvir 600 mg alone in Period 1 and (2) carbamazepine q12h (BID) titrated from 100 mg to 300 mg over 15 days with a single ibuzatrelvir 600 mg dose coadministered on day 15 in Period 2. All treatments will be taken by mouth.

All participants will remain in the study clinic for 18 days for safety review, laboratory collections, and to collect samples for PK.

All participants selected in the study will be required to go through a screening period up to 28 days. A screening period is the time during which a few participants are examined to see whether they are fit for the study. During this period, the participant's medical history and past and current medications will be reviewed. A series of tests will also be performed to see if they are good to be selected for the study. If the participant meets all required criteria and are interested in continuing, the participant will be brought into the study clinic to stay overnight for 18 days. About 28 to 35 days after discharge following the final treatment, the participant will be contacted for a follow up visit either in person or by telephone. This is to check up on how the participant is doing and to conclude the study.

Conditions
Healthy
Being tested
ibuzatrelvir, carbamazepine ER
Keywords
Healthy Participants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ibuzatrelvirDrug

    Also called PF-07817883

    2x 300 mg tablet

  • carbamazepine ERDrug

    100 mg BID (Day 1-3) 200 mg BID (Day 4-7) 300 mg BID (Day 8-15)

Study groups in NCT06646042
Study groupRoleWhat they receive
Period 1Experimentalibuzatrelvir single oral dose on Day 1.
Receives: Drug: ibuzatrelvir
Period 2Experimentalcarbamazepine BID oral doses on Day 1-15. ibuzatrelvir single oral dose on Day 14.
Receives: Drug: ibuzatrelvir; Drug: carbamazepine ER

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Plasma Concentration (Cmax) of ibuzatrelvir

    Measured: Hour 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48 post-dose in each period

  2. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of ibuzatrelvir

    if data permits

    Measured: Hour 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48 post-dose in each period

  3. Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) ofibuzatrelvir

    Measured: Hour 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48 post-dose in each period

Secondary outcomes (3)

  1. Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

    Measured: Baseline (Day 0) up to 35 days after last dose of study medication

  2. Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities

    Measured: Baseline up to Day 18

  3. Number of Participants With Clinically Significant Change From Baseline in Vital Signs

    Measured: Baseline up to Day 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2024
  2. Study start28 Oct 2024
  3. Primary completion17 Jan 2025
  4. Study completion17 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Single group
Model description
open-label, 2-period, fixed sequence
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06646042
Sponsor's protocol ID
C5091009
Status last verified
Jan 2025
First submitted
15 Oct 2024
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ibuzatrelvir and carbamazepine ER in people with Healthy, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Concentration (Cmax) of ibuzatrelvir (time frame: Hour 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48 post-dose in each period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06646042.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in