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.

NCT06541678 | Completed Phase 1 FDA Drug

• 2 other identifiers: C34210632024-513863-21-00
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

danuglipron; cyclosporine; itraconazole; DDI

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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.

  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

  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

  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

  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

  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

  Day 1 up to approximately Day 47

Study Arms (3)

Period 1: Danuglipron

ACTIVE COMPARATOR

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

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.

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.

Drug: Danuglipron; Drug: Itraconazole

Interventions

Danuglipron DRUG

MR Tablet

Also known as: PF-06882961

Period 1: Danuglipron; Period 2: Cyclosporine + Danuglipron; Period 3: Itraconazole + Danuglipron

Cyclosporine DRUG

Capsule

Period 2: Cyclosporine + Danuglipron

Itraconazole DRUG

Oral solution

Period 3: Itraconazole + Danuglipron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

danuglipron; Cyclosporine; Itraconazole

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase 1, open-label, fixed-sequence, 3-period study

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 7, 2024
• Study Start: December 23, 2024
• Primary Completion: March 10, 2025
• Study Completion: March 10, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)