A Study to Learn About How Itraconazole Affects the Blood Level of Study Medicine (PF-07817883) in Healthy Adults.

NCT05822440 | Completed Phase 1 Results FDA Drug

• 1 other identifier: C5091008
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn how Itraconazole affects the blood level of PF-07817883 in Healthy Adults. This study is seeking participants who are:

• male and female aged 18 to 65 years old,
• overtly healthy. This can be determined my medical evaluation, medical history, lab tests etc. This study will consist of 2 parts, Period 1 and Period 2. Period 1: participants will take PF-07817883 one time by mouth at the study clinic. Period 2: participants will take PF-07817883 one time by mouth at the study clinic. They will also take daily itraconazole by mouth for 7 days. Participants will stay at the study clinic for 2 weeks in total. The study doctors will collect blood and urine samples from everyone. The study doctors will check participants' reactions to the study medicine for safety measures. There is a follow-up call at 28 to 35 days from the last dose of PF-07817883. Itraconazole is an approved medicine. It is also a metabolism inhibitor. When taken with some medicines, it affects the actual level of these medicines in the body. This study will compare blood levels of PF-07817883 given with and without Itraconazole. This will help decide safety and right amount for PF-07817883 when given with metabolism inhibitors.

Conditions

Healthy

Keywords

COVID-19

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Concentration (Cmax) of PF-07817883

  Cmax was observed directly from data and measured in nanogram per milliliter (ng/mL).

  Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4

• Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883

  AUCinf was derived by AUClast + (Clast\*/kel). AUClast was area under the plasma concentration-time profile from time 0 to the time of Clast; Clast\* was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. AUCinf was measured in nanogram\*hour per milliliter (ng\*hr/mL).

  Period 1: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 1; Period 2: Pre-dose (0 hour), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose on Day 4

Secondary Outcomes (9)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  Day 1 of dosing up to 35 days post last dose of study intervention (maximum up to 48 days)

• Number of Participants With Laboratory Test Abnormalities

  Day 1 of dosing up to last dose of study intervention or early termination/discontinuation (maximum up to 13 days)

• Number of Participants With Electrocardiogram (ECG) Findings Per Pre-defined Criteria

  Day 1 of dosing up to last dose of study intervention or early termination/discontinuation (maximum up to 13 days)

• Number of Participants With Vital Signs Findings Per Pre-defined Criteria

  Day 1 of dosing up to last dose of study intervention or early termination/discontinuation (maximum up to 13 days)

• Number of Participants With Clinically Significant Abnormalities in Physical Examination

  Day 1 of dosing up to last dose of study intervention or early termination/discontinuation (maximum up to 13 days)

Study Arms (2)

Period 1

EXPERIMENTAL

The treatment arm includes a single dose of PF-07817883 (Period 1 Day 1)

Drug: PF-07817883

Period 2

EXPERIMENTAL

This treatment arm includes 7-day dosing of itraconazole with a single dose of PF-07817883 Co-administered on Day 4 (Period 2 Day 4)

Drug: PF-07817883; Drug: Itraconazole

Interventions

PF-07817883 DRUG

Single oral dose (period 1) or co-administered with itraconazole (period 2)

Period 1; Period 2

Itraconazole DRUG

Interacting drug which will be given for 7 days in period 2

Also known as: Sporanox®

Period 2

Eligibility Criteria

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

You may qualify if:

• Male and female participants aged 18 to 65 years of age, inclusive, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and standard 12-lead ECG.
• BMI of 17.5 to 32 kg/m2; and a total body weight \>50 kg (110 lb).
• Capable of giving signed informed consent.

You may not qualify if:

• Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, CV, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
• Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
• Positive test result for SARS-CoV-2 infection at admission.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Links

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

MeSH Terms

Conditions

COVID-19

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquires@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Masking: None (open label)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: April 20, 2023
• Study Start: April 13, 2023
• Primary Completion: July 10, 2023
• Study Completion: July 10, 2023
• Last Updated: October 4, 2024
• Results First Posted: October 4, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)