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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Period 1 | Experimental | A single oral dose of PF-07258669 on Study Day 1 |
|
| Part A: Period 2 | Experimental | Itraconazole QD orally on Study Days 4 to 11. PF-07258669 will be co administered on Study Day 7. |
|
| Part B: Sequence 1 | Experimental | A single oral dose of PF-07258669 on Study Days 1 and 4 under fasted and fed conditions respectively. |
|
| Part B: Sequence 2 | Experimental | A single oral dose of PF-07258669 on Study Days 1 and 4 under fed and fasted conditions respectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07258669 | Drug | Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events | Baseline to Day 46 (Part A); Baseline to Day 39 (Part B) |
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Inclusion Criteria:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Centers of America ( Hollywood ) | Hollywood | Florida | 33024 | United States | ||
| Research Centers of America |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Parts A and B are not masked. Part A is not randomized. Part B is randomized to Sequence 1 or Sequence 2.
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| Itraconazole | Drug | Solution |
|
| Hollywood |
| Florida |
| 33024 |
| United States |
| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
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