HealthyPhase 1NCT06541678
A Study to Learn if the Study Medicines Called Itraconazole and Cyclosporine Change How the Body Processes the Other Study Medicine Called Danuglipron in Healthy Adults.
A Phase 1 study testing Danuglipron, Cyclosporine and Itraconazole in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to see how single dose of cyclosporine and multiple doses of itraconazole affect the level of the study medicine danuglipron in the blood of healthy adult participants. 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?
- Danuglipron, Cyclosporine and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2024to 10 Mar 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
- Male and female 18 years of age or older (or the minimum age of consent in accordance with local regulations) at screening 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.
- BMI of 16-32 kg/m2; and a total body weight >50 kg (110 lb).
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal (including acute pancreatitis or a history of chronic pancreatitis), 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 infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.
- Known intolerance or hypersensitivity to GLP-1R agonists.
- Known hypersensitivity to itraconazole or cyclosporine.
- Personal or family history of MTC or MEN2, or participants with suspected MTC per the investigator's judgment.
Show all 24Show fewer
- 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.
- Prior/Concomitant Therapy:
- Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 5 half lives (whichever is longer; 14 days plus 5 half-lives for moderate or strong CYP3A inducers) prior to the first dose of study intervention (Refer to Section 6.9 for additional details).
- Prior or current use of any prohibited concomitant medication(s) (Refer to Section 6.9 for additional details).
- Prior/Concurrent Clinical Study Experience:
- Previous administration of an investigational product (drug or vaccine) within 30 days 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.
- Known prior participation (ie, randomized and received at least 1 dose of investigational product) in a study involving danuglipron.
- A positive urine drug test at Screening or Day -1.
- 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 BP ≥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 units of mL/min/1.73 m²) as determined by the CKD-EPI equation using Screat as described in Section 10.7.2.
- 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 segment and/or T wave 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 an investigator 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:
- ALT or AST ≥1.5× ULN;
- Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ULN;
- Hemoglobin A1c (HbA1c) ≥6.5%;
- Fasting blood glucose ≥126 mg/dL (7 mmol/L).
- History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening.
- Use of tobacco/nicotine containing products in excess of the equivalent of 5 cigarettes/day or 2 chews of tobacco/day.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, 06511
About this study
Official title: A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Itraconazole and Cyclosporine on the Single-Dose Pharmacokinetics of Danuglipron in Healthy Adult Participants
The purpose of this study is to see how single dose of cyclosporine and multiple doses of itraconazole affect the level of the study medicine danuglipron in the blood of healthy adult participants. The information from this study may inform how danuglipron will be used in the future with medicines like cyclosporine and itraconazole.
Read the detailed description
This study is seeking healthy participants who:
- are aged 18 years of age or older.
- are confirmed to be healthy by some medical tests.
- both men and women can participate. Women who can produce a baby must agree to use a highly effective method of birth control.
- have body mass index (BMI) of 16 to 32 kilograms per meter squared.
- a total body weight of more than 50 kilograms.
Participants will receive danuglipron tablet by mouth on Day 1. Then on Day 4, participants will take cyclosporine capsules and danuglipron tablet by mouth at the same time. From Day 7 of the study, participants will take itraconazole solution by mouth once a day until Day 12. On Day 10 of the study, danuglipron tablet will also be taken with itraconazole at the same time.
The total planned time of participation is about 10 weeks. The study consists of:
screening period of up to 28 days before taking sisunatovir. 13 days of staying in the study clinic. a follow-up contact that will occur 28 to 35 days after taking itraconazole the last time.
- Conditions
- Healthy
- Being tested
- Danuglipron, Cyclosporine, Itraconazole
- Keywords
- danuglipron, cyclosporine, itraconazole, DDI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DanuglipronDrug
Also called PF-06882961
MR Tablet
CyclosporineDrug
Capsule
ItraconazoleDrug
Oral solution
| Study group | Role | What they receive |
|---|---|---|
| Period 1: Danuglipron | Active comparator | Participants will receive a single 20 mg dose of danuglipron on Day 1. Receives: Drug: Danuglipron |
| Period 2: Cyclosporine + Danuglipron | Experimental | Participants will receive a single 20 mg dose of danuglipron and a single 600 mg dose of cyclosporine on Day 1. Receives: Drug: Danuglipron; Drug: Cyclosporine |
| Period 3: Itraconazole + Danuglipron | Experimental | Participants will receive itraconazole daily for 6 days plus a single dose of danuglipron on Day 4. Receives: Drug: Danuglipron; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCinf (if data permits otherwise AUClast): to estimate the effect of a single dose of cyclosporine on the single-dose PK of a MR formulation of danuglipron in healthy adult participants.
AUCinf: Area under the plasma concentration time profile from time zero extrapolated to infinite time
AUClast: Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration.
Measured: 0 to 72 hour postdose
Cmax: to estimate the effect of a single dose of cyclosporine on the single-dose PK of a MR formulation of danuglipron in healthy adult participants.
Maximum observed plasma concentration
Measured: 0 to 72 hour postdose
AUCinf (if data permits otherwise AUClast): to estimate the effect of multiple doses of itraconazole on the single-dose PK of a MR formulation of danuglipron in healthy adult participants.
AUCinf: Area under the plasma concentration time profile from time zero extrapolated to infinite time
AUClast: Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration.
Measured: 0 to 72 hour postdose
Cmax: to estimate the effect of multiple doses of itraconazole on the single-dose PK of a MR formulation of danuglipron in healthy adult participants.
Maximum observed plasma concentration
Measured: 0 to 72 hour postdose
Secondary outcomes (4)
Number of Participants With Treatment Emergent Adverse Events Following Single Doses of Danuglipron administered separately and in combination with itraconazole or cyclosporine
Measured: Day 1 up to approximately Day 47
Number of Participants With Clinical Laboratory Abnormalities Following Single Doses of Danuglipron administered separately and in combination with itraconazole or cyclosporine
Measured: Day 1 up to approximately Day 47
Number of Participants With Clinically Significant Change from Baseline Vital Signs Following Single Doses of Danuglipron administered separately and in combination with itraconazole or cyclosporine
Measured: Day 1 up to approximately Day 47
Number of Participants With Clinically Significant Change from Baseline in Electrocardiogram Findings Following Single Doses of Danuglipron administered separately and in combination with itraconazole or cyclosporine
Measured: Day 1 up to approximately Day 47
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start23 Dec 2024
- Primary completion10 Mar 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is a Phase 1, open-label, fixed-sequence, 3-period study
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT06541678
- Sponsor's protocol ID
- C3421063
- Other IDs
- 2024-513863-21-00
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2024
- Last updated
- 3 Aug 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 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Itraconazole and Cyclosporine on the Single-Dose Pharmacokinetics of Danuglipron in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06541678
- Acronym / sponsor ID
- C3421063
- Conditions
- Healthy
- Keywords
- danuglipron, cyclosporine, itraconazole, DDI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 7 Aug 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.
The purpose of this study is to see how single dose of cyclosporine and multiple doses of itraconazole affect the level of the study medicine danuglipron in the blood of healthy adult participants. The information from this study may inform how danuglipron will be used in the future with medicines like cyclosporine and itraconazole.
Detailed description
This study is seeking healthy participants who:
- are aged 18 years of age or older.
- are confirmed to be healthy by some medical tests.
- both men and women can participate. Women who can produce a baby must agree to use a highly effective method of birth control.
- have body mass index (BMI) of 16 to 32 kilograms per meter squared.
- a total body weight of more than 50 kilograms.
Participants will receive danuglipron tablet by mouth on Day 1. Then on Day 4, participants will take cyclosporine capsules and danuglipron tablet by mouth at the same time. From Day 7 of the study, participants will take itraconazole solution by mouth once a day until Day 12. On Day 10 of the study, danuglipron tablet will also be taken with itraconazole at the same time.
The total planned time of participation is about 10 weeks. The study consists of:
screening period of up to 28 days before taking sisunatovir. 13 days of staying in the study clinic. a follow-up contact that will occur 28 to 35 days after taking itraconazole the last time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a Phase 1, open-label, fixed-sequence, 3-period study
| Arm | Type | Receives |
|---|---|---|
| Period 1: Danuglipron | Active comparator | Drug: DanuglipronParticipants will receive a single 20 mg dose of danuglipron on Day 1. |
| Period 2: Cyclosporine + Danuglipron | Experimental | Drug: Danuglipron, Drug: CyclosporineParticipants will receive a single 20 mg dose of danuglipron and a single 600 mg dose of cyclosporine on Day 1. |
| Period 3: Itraconazole + Danuglipron | Experimental | Drug: Danuglipron, Drug: ItraconazoleParticipants will receive itraconazole daily for 6 days plus a single dose of danuglipron on Day 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female 18 years of age or older (or the minimum age of consent in accordance with local regulations) at screening 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.
- BMI of 16-32 kg/m2; and a total body weight >50 kg (110 lb).
Key exclusion criteria (24 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal (including acute pancreatitis or a history of chronic pancreatitis), cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Personal or family history of MTC or MEN2, or participants with suspected MTC per the investigator's judgment.
- 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 14 days or 5 half lives (whichever is longer; 14 days plus 5 half-lives for moderate or strong CYP3A inducers) prior to the first dose of study intervention (Refer to Section 6.9 for additional details).
- Prior or current use of any prohibited concomitant medication(s) (Refer to Section 6.9 for additional details).
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 |
|---|---|---|
| DanuglipronAlso: PF-06882961MR Tablet | Drug | Period 1: Danuglipron, Period 2: Cyclosporine + Danuglipron, Period 3: Itraconazole + Danuglipron |
| CyclosporineCapsule | Drug | Period 2: Cyclosporine + Danuglipron |
| ItraconazoleOral solution | Drug | Period 3: Itraconazole + Danuglipron |
Primary outcome
AUCinf (if data permits otherwise AUClast): to estimate the effect of a single dose of cyclosporine on the single-dose PK of a MR formulation of danuglipron in healthy adult participants.
Time frame: 0 to 72 hour postdose
AUCinf: Area under the plasma concentration time profile from time zero extrapolated to infinite time AUClast: Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration.
Cmax: to estimate the effect of a single dose of cyclosporine on the single-dose PK of a MR formulation of danuglipron in healthy adult participants.
Time frame: 0 to 72 hour postdose
Maximum observed plasma concentration
AUCinf (if data permits otherwise AUClast): to estimate the effect of multiple doses of itraconazole on the single-dose PK of a MR formulation of danuglipron in healthy adult participants.
Time frame: 0 to 72 hour postdose
AUCinf: Area under the plasma concentration time profile from time zero extrapolated to infinite time AUClast: Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration.
Cmax: to estimate the effect of multiple doses of itraconazole on the single-dose PK of a MR formulation of danuglipron in healthy adult participants.
Time frame: 0 to 72 hour postdose
Maximum observed plasma concentration
4 secondary outcomes
Number of Participants With Treatment Emergent Adverse Events Following Single Doses of Danuglipron administered separately and in combination with itraconazole or cyclosporine
Time frame: Day 1 up to approximately Day 47
Number of Participants With Clinical Laboratory Abnormalities Following Single Doses of Danuglipron administered separately and in combination with itraconazole or cyclosporine
Time frame: Day 1 up to approximately Day 47
Number of Participants With Clinically Significant Change from Baseline Vital Signs Following Single Doses of Danuglipron administered separately and in combination with itraconazole or cyclosporine
Time frame: Day 1 up to approximately Day 47
Number of Participants With Clinically Significant Change from Baseline in Electrocardiogram Findings Following Single Doses of Danuglipron administered separately and in combination with itraconazole or cyclosporine
Time frame: Day 1 up to approximately Day 47
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 3 Aug 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 Danuglipron, Cyclosporine and Itraconazole 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 24 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 Aug 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?
AUCinf (if data permits otherwise AUClast): to estimate the effect of a single dose of cyclosporine on the single-dose PK of a MR formulation of danuglipron in healthy adult participants. (time frame: 0 to 72 hour postdose). The study lists 4 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 3 Aug 2025.