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NCT06706869 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn if the Study Medicine Called Itraconazole and if Food Changes How the Body Processes the Other Study Medicine Called PF 07258669 in Older Adults or Healthy Adults
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT06706869 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 26 participants.
The verdict
NCT06706869, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
The purpose of this study is to learn how the medicine called itraconazole and food changes how the body processes another study medicine called PF-07258669 in older adults or healthy adults. The study medicine PF-07258669 is developed for the treatment of unintended weight loss in older adults. People with this condition have decreased appetite and food intake, which is an important reason for poor nutrition and health results in people with unintended weight loss. The study has two parts: Part A and Part B. The study is seeking participants who: 1. Are males or females who can no longer have children. 2. Part A Only: Are at least 65 years old and in reasonably good health. Part B Only: Are at least 18 years old and in good health. 3. Part A Only: Have a body mass index (BMI) of 16 to 27 kilogram per meter squared and a total body weight of more than 40 kilograms (88 pounds). Part B Only: Have a BMI of 16-32 kilogram per meter squared and a total body weight of more than 50 kilograms (110 pounds). For Part A: Participants will take the study medicine PF-07258669 as tablets by mouth once on Day 1 at the study clinic and stay at the clinic for about 12 days. Then starting on Day 4, participants will take itraconazole as liquid by mouth for eight days. On Day 7, itraconazole will be taken together with PF-07258669. For Part B: Participants will take the study medicine PF-07258669 as tablets by mouth once on Day 1 without breakfast at the study clinic and stay at the clinic for about 7 days. On Day 4, participant will take the study medicine after breakfast. A different group of participants will follow a similar procedure, but they will take the medicine after breakfast on Day 1 and without breakfast on Day 4. For Parts A and B: At the clinic, the study team will observe the participants and take urine and blood samples to look at the levels of PF-07258669. The participants will receive a follow up telephone call about one month later.
Interventions
- DRUG Itraconazole
- DRUG PF-07258669
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2024-12-11 |
| Est. Completion | 2025-02-20 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06706869
The ClinicalTrials.gov registry entry for NCT06706869 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Itraconazole is the first listed.
NCT06706869 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06706869 about?
NCT06706869 is a clinical study titled "A Study to Learn if the Study Medicine Called Itraconazole and if Food Changes How the Body Processes the Other Study Medicine Called PF 07258669 in Older Adults or Healthy Adults". The purpose of this study is to learn how the medicine called itraconazole and food changes how the body processes another study medicine called PF-07258669 in older adults or healthy adults. The study medicine PF-07258669 is developed for the treatment of unintended weight loss in older adults. Pe...
What is the current status of trial NCT06706869?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2024-12-11. Estimated completion is 2025-02-20.
What interventions are being tested in trial NCT06706869?
The interventions under investigation include: Itraconazole (DRUG), PF-07258669 (DRUG).
Who is sponsoring clinical trial NCT06706869?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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