Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| C5341047 | 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
A Phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral dose of GBT440 administered in subjects with mild (Child-Pugh A), moderate (Child-Pugh B), or severe (Child-Pugh C) hepatic impairment disease and healthy subjects with normal hepatic function.
Approximately 24 to 28 subjects will be enrolled. Safety and PK assessments will be performed at selected time points throughout the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GBT440 Dose 1:Mild hepatic impairment | Experimental | Child Pugh A |
|
| GBT440 Dose 1:Moderate hep. impairment | Experimental | Child Pugh B |
|
| GBT440 Dose 1:Severe hepatic impairment | Experimental | Child Pugh C |
|
| GBT440 Dose 1:Normal hepatic function | Experimental | Healthy subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GBT440 | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the Cmax of GBT440 in patients with mild, moderate, or severe hepatic impairment | Maximum observed plasma concentration | 28 days max |
| To assess the Tmax of GBT440 in patients with mild, moderate, or severe hepatic impairment | Time at which maximum concentration was observed | 28 days max |
| To assess the AUC of GBT440 in patients with mild, moderate, or severe hepatic impairment | Area under the concentration-time curve | 28 days max |
| To assess the T1/2 of GBT440 in patients with mild, moderate, or severe hepatic impairment | Terminal elimination half-life | 28 days max |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 28 days max | |
| Clinical laboratory tests | 28 days max | |
| Physical examination findings |
Not provided
Inclusion Criteria:
All subjects:
Patients with hepatic impairment:
Healthy subjects:
Exclusion Criteria:
All subjects:
Patients with hepatic impairment:
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 |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States | ||
| OCRC |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000628792 | voxelotor |
Not provided
Not provided
Not provided
Multiple-center, nonrandomized, open-label, parallel group study
Not provided
Not provided
Not provided
Not provided
| 28 days max |
| Vital signs | 28 days max |
| Electrocardiograms | 28 days max |
| Orlando |
| Florida |
| 32809 |
| United States |