Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| GBT601 | Other Identifier | Alias Study Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to understand how Osivelotor is processed in people with loss of liver function.
This study is seeking participants that are:
All participants will receive one amount of Osivelotor by mouth before breakfast on the first day at the study clinic. A number of blood samples will be collected to understand how Osivelotor is changed and removed from the body. Participants will also have to undergo physical examination and other tests. This will help to understand if Osivelotor is safe.
Participants will take part in the study for a maximum of 112 days. During this time, participants will have to stay onsite for 5 days. There will be 5 study visits at the study clinic.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Participants with moderate hepatic impairment will receive a single dose of osivelotor, administered orally under fasted conditions. |
|
| Group 2 | Experimental | Participants with mild hepatic impairment will receive a single dose of osivelotor, administered orally under fasted conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osivelotor | Drug | a single dose of osivelotor administered by mouth under fasted conditions Other Names: PF-07940367 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the whole blood and plasma concentration versus time curve (AUC) from time zero (pre-dose) to the last quantifiable concentration (AUClast) of osivelotor | 0 hours (pre-dose) to 84 days post-osivelotor dose | |
| Area under the whole blood and plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (AUCinf) of osivelotor | 0 hours (pre-dose) to 84 days post-osivelotor dose | |
| Maximum observed whole blood and plasma concentration (Cmax) of osivelotor | 0 hours (pre-dose) to 84 days post-osivelotor dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) | From baseline up to 56 days after osivelotor dose | |
| Number of Participants With Clinically Significant Laboratory Abnormalities | From baseline up to 84 days after osivelotor dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Research Center | Lake Forest | California | 92630 | United States | ||
| Genesis Clinical Research, LLC |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
Not provided
Not provided
An open label, single dose, parallel cohort study
Not provided
Not provided
Not provided
Not provided
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | From baseline up to 84 days after osivelotor dose |
| Number of Participants With Clinically Significant With Clinically Significant Vital Signs | From baseline up to 84 days after osivelotor dose |
| Tampa |
| Florida |
| 33603 |
| United States |
| Thomas Jefferson University-Pharmacology, Physiology and Cancer Biology | Philadelphia | Pennsylvania | 19107 | United States |