SARS-CoV-2 InfectionsPhase 1NCT06693518
A Study to Learn About if the Study Medicine Called Ibuzatrelvir Changes How the Body Process the Other Medicine Dabigatran Etexilate in Healthy Adults
A Phase 1 study testing Treatment B and Treatment A in people with SARS-CoV-2 Infections, run by Pfizer at 1 site in Belgium.
Trial summary
This is a Phase 1, open-label, randomized, 2-period, 2-sequence, cross-over study to estimate the effect of ibuzatrelvir on the PK of dabigatran, a P-gp substrate, in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infections
- What is being tested?
- Treatment B and Treatment A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Nov 2024to 15 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female participants 18 to 75 years of age, inclusive, at screening who are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and standard 12-lead ECGs.
- BMI of 17.5 to 32 kg/m2; and a total body weight >50 kg (110 lb).
- Capable of giving signed informed consent.
- Willing and able to comply with all scheduled visits, treatment plans, laboratory tests, lifestyle considerations, and other study procedures.
Who cannot join
- 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) and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy). History of HIV infection, hepatitis B, or hepatitis C. Positive testing for HIV, HBsAg, or HCVAb. 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 28 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
- Participation in other studies involving study intervention within 30 days or 5 half-lives (whichever is longer) prior to study entry. Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.
- Active bleeding or risk of bleeding, including prior personal or family history of abnormal bleeding, hereditary or acquired coagulation or platelet disorder or abnormal coagulation test (PT/INR or PTT/aPTT) greater than the upper limit of normal result at screening. Any significant risk factor for major bleeding, which may include but is not limited to current or recent GI ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal, or ophthalmic surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms, or major intraspinal or intracerebral vascular abnormalities.
- A positive urine drug test. A single repeat for positive drug screen may be allowed.
Show all 18Show fewer
- Pregnant or breastfeeding women or evidence of positive pregnancy test at screening or Study Day -1.
- Screening supine BP ≥ 140 mmHg (systolic) or ≥90 mmHg (diastolic) for participants <60 years and ≥150/90 mmHg for participants ≥60 years old, following at least 5 minutes of supine rest. If systolic BP is ≥ 140 or 150 mmHg (based on age) or diastolic BP is ≥ 90 mmHg, the BP should be repeated two more times, and the average of the three BP values should be used to determine the participant's eligibility.
- An eGFR of <75 mL/min as determined by CKD-EPI equation using Screat as described in Section
- Screening supine standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF > 450 msec or QRS interval > 120 msec, 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 the uncorrected QT interval is > 450 msec, this interval should be rate-corrected using the Fridericia method only, and the resulting QTcF should be used for decision making and reporting. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated twice, and the average of the three QTcF or QRS values should be 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, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:
- AST or ALT ≥1.5 × ULN Total bilirubin ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin is ≤ ULN PT/INR or PTT/aPTT >1.0 × ULN
- Participants who have recently underwent a surgery or invasive procedure prior to study enrollment, or who anticipate requiring it during study conduct, are ineligible for this study.
- History of sensitivity reactions to dabigatran etexilate or any of the formulation components of ibuzatrelvir or dabigatran etexilate.
- Have any medical conditions, medical history, or are taking any medications that are contraindicated in the dabigatran etexilate prescribing information.
- History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit, or 3 ounces (90 mL) of wine).
- Use of tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes per day or two chews of tobacco per day.
- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070
About this study
Official title: A PHASE 1, OPEN-LABEL, RANDOMIZED, 2-PERIOD, 2-SEQUENCE, CROSSOVER STUDY TO ESTIMATE THE EFFECT OF IBUZATRELVIR ON THE PHARMACOKINETICS OF DABIGATRAN IN HEALTHY ADULT PARTICIPANTS
This is a Phase 1, open-label, randomized, 2-period, 2-sequence, cross-over study to estimate the effect of ibuzatrelvir on the PK of dabigatran, a P-gp substrate, in healthy adult participants. Participants who discontinue from the study for non-safety reasons may be replaced at the Sponsor's discretion in collaboration with the investigator.
Healthy participants will be screened to determine eligibility within 28 days prior to study treatment. Participants will report to the CRU on Period 1 Day -1 in Period 1 and will be required to stay at the CRU until discharge Day 3 in Period 2.
Read more
This study will consist of two treatments. Treatment A: 150 mg of dabigatran etexilate; Treatment B: ibuzatrelvir 600 mg + 150 mg of dabigatran etexilate. The participants will be fasted overnight for at least 10 hours before administration of study intervention. Serial dabigatran samples will be collected up to 48 hours post-dose in both Period 1 and Period 2. Dosing of dabigatran in Period 1 and 2 will be separated by approximately 72h.
A follow-up (which may be a phone call) will be made to participants approximately 28 to 35 days from administration of the final dose of study intervention.
Approximately 20 participants will be enrolled in the study. PK samples will be collected for Dabigatran and Ibuzatrelvir as per SOA.
- Conditions
- SARS-CoV-2 Infections
- Being tested
- Treatment B, Treatment A
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment BDrug
Ibuzatrelvir 600 mg + Dabigatran Etexilate 150 mg
Treatment ADrug
Dabigatran Etexilate 150 mg
| Study group | Role | What they receive |
|---|---|---|
| Treatment A= Dabigatran Etexilate 150 mg | Experimental | Treatment A= Dabigatran Etexilate 150 mg Receives: Drug: Treatment A |
| Treatment B=Ibuzatrelvir 600 mg + Dabigatran Etexilate 150 mg | Experimental | Treatment B=Ibuzatrelvir 600 mg + Dabigatran Etexilate 150 mg Receives: Drug: Treatment B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Plasma Cmax (Maximum observed concentration) of Dabigatran with ibuzatrelvir (Test) versus without ibuzatrelvir (Reference)
Measured: 0 - 48 hours
AUCinf
Plasma AUCinf of Dabigatran with ibuzatrelvir (Test) versus without ibuzatrelvir (Reference)
Measured: 0 - 48 hours
Secondary outcomes (3)
Incidence of treatment-emergent adverse events (TEAEs)
Measured: Day 1 till follow up visit (Day 28-35)
Incidence of clinical laboratory abnormalities
Measured: Day 1 till follow up visit (Day 28-35)
Incidence of vital sign abnormalities
Measured: Day 1 till follow up visit (Day 28-35)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start22 Nov 2024
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693518
- Sponsor's protocol ID
- C5091010
- Other IDs
- 2024-517797-14-00
- Status last verified
- Jan 2025
- First submitted
- 5 Nov 2024
- Last updated
- 24 Jan 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, RANDOMIZED, 2-PERIOD, 2-SEQUENCE, CROSSOVER STUDY TO ESTIMATE THE EFFECT OF IBUZATRELVIR ON THE PHARMACOKINETICS OF DABIGATRAN IN HEALTHY ADULT PARTICIPANTS
- ClinicalTrials.gov ID
- NCT06693518
- Acronym / sponsor ID
- C5091010
- Conditions
- SARS-CoV-2 Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, open-label, randomized, 2-period, 2-sequence, cross-over study to estimate the effect of ibuzatrelvir on the PK of dabigatran, a P-gp substrate, in healthy adult participants. Participants who discontinue from the study for non-safety reasons may be replaced at the Sponsor's discretion in collaboration with the investigator.
Healthy participants will be screened to determine eligibility within 28 days prior to study treatment. Participants will report to the CRU on Period 1 Day -1 in Period 1 and will be required to stay at the CRU until discharge Day 3 in Period 2.
This study will consist of two treatments. Treatment A: 150 mg of dabigatran etexilate; Treatment B: ibuzatrelvir 600 mg + 150 mg of dabigatran etexilate. The participants will be fasted overnight for at least 10 hours before administration of study intervention. Serial dabigatran samples will be collected up to 48 hours post-dose in both Period 1 and Period 2. Dosing of dabigatran in Period 1 and 2 will be separated by approximately 72h.
A follow-up (which may be a phone call) will be made to participants approximately 28 to 35 days from administration of the final dose of study intervention.
Approximately 20 participants will be enrolled in the study. PK samples will be collected for Dabigatran and Ibuzatrelvir as per SOA.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A= Dabigatran Etexilate 150 mg | Experimental | Drug: Treatment ATreatment A= Dabigatran Etexilate 150 mg |
| Treatment B=Ibuzatrelvir 600 mg + Dabigatran Etexilate 150 mg | Experimental | Drug: Treatment BTreatment B=Ibuzatrelvir 600 mg + Dabigatran Etexilate 150 mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female participants 18 to 75 years of age, inclusive, at screening who are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and standard 12-lead ECGs.
- BMI of 17.5 to 32 kg/m2; and a total body weight >50 kg (110 lb).
- Capable of giving signed informed consent.
- Willing and able to comply with all scheduled visits, treatment plans, laboratory tests, lifestyle considerations, and other study procedures.
Key exclusion criteria (18 listed)
- 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) and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy). History of HIV infection, hepatitis B, or hepatitis C. Positive testing for HIV, HBsAg, or HCVAb. 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 28 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
- Participation in other studies involving study intervention within 30 days or 5 half-lives (whichever is longer) prior to study entry. Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.
- Active bleeding or risk of bleeding, including prior personal or family history of abnormal bleeding, hereditary or acquired coagulation or platelet disorder or abnormal coagulation test (PT/INR or PTT/aPTT) greater than the upper limit of normal result at screening. Any significant risk factor for major bleeding, which may include but is not limited to current or recent GI ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal, or ophthalmic surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms, or major intraspinal or intracerebral vascular abnormalities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment BIbuzatrelvir 600 mg + Dabigatran Etexilate 150 mg | Drug | Treatment B=Ibuzatrelvir 600 mg + Dabigatran Etexilate 150 mg |
| Treatment ADabigatran Etexilate 150 mg | Drug | Treatment A= Dabigatran Etexilate 150 mg |
Primary outcome
Cmax
Time frame: 0 - 48 hours
Plasma Cmax (Maximum observed concentration) of Dabigatran with ibuzatrelvir (Test) versus without ibuzatrelvir (Reference)
AUCinf
Time frame: 0 - 48 hours
Plasma AUCinf of Dabigatran with ibuzatrelvir (Test) versus without ibuzatrelvir (Reference)
3 secondary outcomes
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Day 1 till follow up visit (Day 28-35)
Incidence of clinical laboratory abnormalities
Time frame: Day 1 till follow up visit (Day 28-35)
Incidence of vital sign abnormalities
Time frame: Day 1 till follow up visit (Day 28-35)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treatment B and Treatment A in people with SARS-CoV-2 Infections, run by Pfizer at 1 site in Belgium.
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 4 inclusion and 18 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 24 Jan 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 Belgium. 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?
Cmax (time frame: 0 - 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2025.