26 Participants Needed

Itraconazole + PF-07258669 for Healthy Adults

Recruiting at 1 trial location
PC
Overseen ByPfizer CT.gov Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Pfizer
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Research Team

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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

I am unable to have children.
I am at least 65 years old for Part A or at least 18 for Part B.
In reasonably good health
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Exclusion Criteria

I have a history of HIV, hepatitis B, or hepatitis C.
History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening
Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

12 days
In-clinic stay for 12 days

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.

7 days
In-clinic stay for 7 days

Follow-up

Participants are monitored for safety and effectiveness after treatment via a follow-up telephone call.

4 weeks
1 follow-up call

Treatment Details

Interventions

  • Itraconazole
  • PF-07258669
Trial Overview The study tests how itraconazole and food affect the body's processing of PF-07258669, aimed at treating unintended weight loss in older adults. It involves taking these medications under different conditions, with monitoring in a clinic.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Part B: Sequence 2Experimental Treatment1 Intervention
A single oral dose of PF-07258669 on Study Days 1 and 4 under fed and fasted conditions respectively.
Group II: Part B: Sequence 1Experimental Treatment1 Intervention
A single oral dose of PF-07258669 on Study Days 1 and 4 under fasted and fed conditions respectively.
Group III: Part A: Period 2Experimental Treatment2 Interventions
Itraconazole QD orally on Study Days 4 to 11. PF-07258669 will be co administered on Study Day 7.
Group IV: Part A: Period 1Experimental Treatment1 Intervention
A single oral dose of PF-07258669 on Study Day 1

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Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
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Recruited
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Vaccine Innovations
Top Products
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Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

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