A Drug-Drug Interaction Study to Examine the Impact of Itraconazole and Cyclosporine on PF-07081532 Pharmacokinetics in Overweight or Obese Adults

Completed · Phase 1

Conditions studied: Healthy

In brief

This is a Phase 1, open-label, fixed-sequence, 3-period study to evaluate the effect of multiple doses of itraconazole and a single dose of cyclosporine on the single-dose PK of PF-07081532 in otherwise healthy, overweight or obese, adult female and male participants. The 3 study periods will be conducted consecutively without a break.

Key facts

Study ID

NCT05745701

Run by

Pfizer

People needed

16

Starts

2023-02-22

Expected to finish

2023-05-29

Last updated by the study team

2024-09-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Otherwise healthy female and male participants must be at least 18 years of age at the time of signing the ICD (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, physical examination, including blood pressure and pulse rate measurement, standard 12-lead ECG and clinical laboratory tests).
• BMI: ≥25.0 kg/m2 at Screening.
• Stable body weight, defined as <5 kg change (per participant report) for 90 days before Screening.

You may not qualify if…

• 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).
• Diagnosis of type 1 or type 2 diabetes mellitus or secondary forms of diabetes at Screening.
• Any malignancy not considered cured (except basal cell carcinoma and squamous cell carcinoma of the skin)
• Personal or family history of MTC or MEN2, or study participants with suspected MTC per the investigator's judgment.
• Acute pancreatitis, a history of repeated episodes of acute pancreatitis, or history of chronic pancreatitis.
• Symptomatic gallbladder disease.
• Medical history or characteristics suggestive of genetic or syndromic obesity or obesity induced by other endocrinological disorders (eg, Cushing Syndrome).
• History of depressive disorder or history of other severe psychiatric disorders (eg, schizophrenia or bipolar disorder) within the last 2 years from screening.
• Known medical history of active liver disease, including chronic hepatitis B or C, primary biliary cirrhosis, alcoholic liver disease, primary sclerosing cholangitis, autoimmune hepatitis, overlap syndrome, or prior known drug-induced liver injury.
• History of HIV infection.
• Any lifetime history of a suicide attempt.
• Use of prohibited medications
• Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest.
• Standard 12-lead ECG that demonstrates clinically relevant abnormalities that mayaffect participant safety or interpretation of study result.
• Participants with clinical laboratory test abnormalities at Screening. -

Where it is running

• New Haven Clinical Research Unit — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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