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

NCT06706869 | Completed Phase 1 FDA Drug

• 1 other identifier: C4541012
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief 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. 1.Are males or females who can no longer have children.
2. 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. 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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax)

  Baseline to Day 12 (Part A); Baseline to Day 7 (Part B)

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

  Baseline to Day 12 (Part A); Baseline to Day 7 (Part B)

• Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) [if data permit, otherwise AUClast]

  Baseline to Day 12 (Part A); Baseline to Day 7 (Part B)

Secondary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events

  Baseline to Day 46 (Part A); Baseline to Day 39 (Part B)

Study Arms (4)

Part A: Period 1

EXPERIMENTAL

A single oral dose of PF-07258669 on Study Day 1

Drug: PF-07258669

Part A: Period 2

EXPERIMENTAL

Itraconazole QD orally on Study Days 4 to 11. PF-07258669 will be co administered on Study Day 7.

Drug: PF-07258669; Drug: Itraconazole

Part B: Sequence 1

EXPERIMENTAL

A single oral dose of PF-07258669 on Study Days 1 and 4 under fasted and fed conditions respectively.

Drug: PF-07258669

Part B: Sequence 2

EXPERIMENTAL

A single oral dose of PF-07258669 on Study Days 1 and 4 under fed and fasted conditions respectively.

Drug: PF-07258669

Interventions

PF-07258669 DRUG

Tablet

Part A: Period 1; Part A: Period 2; Part B: Sequence 1; Part B: Sequence 2

Itraconazole DRUG

Solution

Part A: Period 2

Eligibility Criteria

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

You may qualify if:

• Males and females who can no longer have children.
• Part A Only: At least 65 years old. Part B Only: At least 18 years old.
• In reasonably good health.
• Part A Only: Body mass index (BMI) of 16-27 kg/m2; and a total body weight \>40 kg (88 lb.). Part B Only: 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 medical conditions.
• History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb).
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Research Centers of America ( Hollywood )

Hollywood, Florida, 33024, United States

Location

Research Centers of America

Hollywood, Florida, 33024, United States

Location

Related Links

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

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

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: Parts A and B are not masked. Part A is not randomized. Part B is randomized to Sequence 1 or Sequence 2.
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 27, 2024
• Study Start: December 11, 2024
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)