← Trials/Trial dossier/NCT06541678

CompletedPhase 1

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, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Itraconazole and Cyclosporine on the Single-Dose Pharmacokinetics of Danuglipron in Healthy Adult Participants

Lead sponsor

Pfizer

Asset

Danuglipron

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

16

actual

Study population

Healthy volunteers

Key I/E criteria

BMI 16-32Healthy volunteers

Primary endpoints

AUCinfTo estimate the effect of a single dose of cyclosporine on the single-dose PKTo estimate the effect of multiple doses of itraconazole on the single-dose PK

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06541678
Org study IDC3421063
Secondary ID2024-513863-21-00CTIS (EU)

Timeline

Milestones

Study first posted2024-08-07actual
Study start2024-12-23actual
Primary completion2025-03-10actual
Study completion2025-03-10actual
Last update posted2025-08-03actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

1. 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.

2. BMI of 16-32 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion criteria

1. 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.

2. Personal or family history of MTC or MEN2, or participants with suspected MTC per the investigator's judgment.

3. 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:

4. 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).

5. Prior or current use of any prohibited concomitant medication(s) (Refer to Section 6.9 for additional details).

Prior/Concurrent Clinical Study Experience:

6. 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.

7. Known prior participation (ie, randomized and received at least 1 dose of investigational product) in a study involving danuglipron.

8. A positive urine drug test at Screening or Day -1.

9. 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.

10. 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.

11. 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.

12. 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).

13. History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening.

14. Use of tobacco/nicotine containing products in excess of the equivalent of 5 cigarettes/day or 2 chews of tobacco/day.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

8 endpoints
Primary/protocol endpoint

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

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

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

Cmax

concentration, descriptive

Primary/protocol endpoint

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

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

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

Cmax

concentration, descriptive

Secondary/protocol endpoint

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

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

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

descriptive

Secondary/protocol endpoint

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

threshold achievement, event

Secondary/protocol endpoint

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

threshold achievement, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.