Itraconazole + PF-07258669 for Healthy Adults
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to assess how itraconazole (an antifungal medication) and food affect the body's processing of PF-07258669, an experimental treatment for unintended weight loss in older adults. The study consists of two parts: Part A for individuals 65 and older, and Part B for adults 18 and up. Participants must be in reasonably good health and have a specific body mass index (BMI), which measures body fat based on height and weight. Interested individuals will stay at a clinic for observation and testing and will take the study medicines as directed. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Earlier research tested PF-07258669 for safety in healthy adults. These studies found it was generally well-tolerated, with most participants experiencing no serious side effects. The safety data indicated no major safety concerns with single doses of PF-07258669.
Itraconazole, approved by the FDA for treating fungal infections, has passed thorough safety checks and is considered safe when used as directed. However, combining itraconazole with other medicines, such as PF-07258669 in this trial, may alter its safety profile.
This study examines how itraconazole affects the body's processing of PF-07258669. While detailed safety data for this specific combination is not yet available, both medicines have been studied individually, and no serious risks have emerged in the trials so far. Researchers will closely monitor participants to ensure their safety during this trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about PF-07258669 and Itraconazole because they offer a potentially new approach to treatment. Unlike standard treatments that might focus on a single mode of action, PF-07258669 is being evaluated for its effects when combined with Itraconazole, a known antifungal medication. This combination could interact in unique ways to enhance therapeutic effects or reduce side effects. Moreover, the study also explores how different conditions, like being fed or fasted, might influence the drug's effectiveness, offering insights into optimizing drug administration for better outcomes.
What evidence suggests that this trial's treatments could be effective for unintended weight loss?
Research has shown that PF-07258669 is being developed to assist older adults experiencing unintentional weight loss, often due to reduced appetite and food intake. In this trial, some participants will receive PF-07258669 alone, while others will receive it with Itraconazole. Early studies in healthy adults indicate that PF-07258669 is quickly absorbed by the body. The drug likely works by affecting specific brain areas that control appetite. Although more information is needed, these findings suggest that PF-07258669 could help improve appetite and nutrition in those experiencing unintended weight loss.36789
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
This trial is for older adults or healthy adults who can't have children. Older participants (65+) should be reasonably healthy with a BMI of 16-27 and weigh over 88 pounds. Younger adults (18+) need a BMI of 16-32 and weigh over 110 pounds.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A
Participants take PF-07258669 on Day 1 and stay at the clinic for about 12 days. Itraconazole is taken from Day 4 to Day 11, with co-administration on Day 7.
Treatment Part B
Participants take PF-07258669 on Day 1 and Day 4 under different fed conditions, staying at the clinic for about 7 days.
Follow-up
Participants are monitored for safety and effectiveness after treatment via a follow-up telephone call.
What Are the Treatments Tested in This Trial?
Interventions
- Itraconazole
- PF-07258669
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University