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CompletedNCT06541678Updated Aug 3, 2025

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 interventional study of Danuglipron and Cyclosporine in Healthy, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-03.

Sponsored by Pfizer · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Mar 2025, 1 year 6 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Healthy

Keywords

  • danuglipron
  • cyclosporine
  • itraconazole
  • DDI
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Active comparator
    Period 1: Danuglipron

    Participants will receive a single 20 mg dose of danuglipron on Day 1.

    Drug: Danuglipron

  • Experimental
    Period 2: Cyclosporine + Danuglipron

    Participants will receive a single 20 mg dose of danuglipron and a single 600 mg dose of cyclosporine on Day 1.

    Drug: Danuglipron · Drug: Cyclosporine

  • Experimental
    Period 3: Itraconazole + Danuglipron

    Participants will receive itraconazole daily for 6 days plus a single dose of danuglipron on Day 4.

    Drug: Danuglipron · Drug: Itraconazole

Interventions

  • DrugDanuglipron

    MR Tablet

    Also known as: PF-06882961

  • DrugCyclosporine

    Capsule

  • DrugItraconazole

    Oral solution

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 0 to 72 hour postdose

  2. 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

    Time frame: 0 to 72 hour postdose

  3. 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.

    Time frame: 0 to 72 hour postdose

  4. 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

    Time frame: 0 to 72 hour postdose

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

07

Study locations

1 site
  • Pfizer Clinical Research Unit - New Haven
    New Haven, Connecticut 06511, United States
08

References and documents

Individual participant data

Plan to share: 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06541678
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Aug 7, 2024
Start date
Dec 23, 2024
Primary completion
Mar 10, 2025
Completion
Mar 10, 2025
Last update
Aug 3, 2025

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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