A Study to Learn if the Study Medicine Called Itraconazole Changes How the Body Processes the Other Study Medicine Called PF-07258669 In Older Adults

Phase 1

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: PF-07258669; Drug: Itraconazole

• Registration Number: NCT06706869
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to learn if the medicine called itraconazole changes how the body processes another study medicine called PF-07258669 in older adults.
...

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-11-25
• Last Update Submitted: 2024-11-25
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27
• Study Start: 2025-01-02
• Primary Completion: 2025-02-11
• Study Completion: 2025-02-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. Males and females who can no longer have children.

2. In reasonably good health.

3. Body mass index (BMI) of 16-27 kg/m2; and a total body weight >40kg (88 lb.).

Exclusion criteria

1. Evidence or history of clinically significant medical conditions.
2. 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).
3. History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
4. Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Period 1	PF-07258669	A single oral dose of PF-07258669 on Study Day 1
Period 2	PF-07258669	Itraconazole QD orally on Study Days 4 to 11. PF-07258669 will be co administered on Study Day 7.
Period 2	Itraconazole	Itraconazole QD orally on Study Days 4 to 11. PF-07258669 will be co administered on Study Day 7.

Primary Outcome Measures

Name	Time	Method
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) [if data permit, otherwise AUClast]	Baseline to Day 12
Maximum Observed Plasma Concentration (Cmax)	Baseline to Day 12
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	Baseline to Day 12

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events	Baseline to Day 46