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The purpose of this study is to measure the effect of HI on the PK, safety, and tolerability of a single dose of mavorixafor compared to matched healthy volunteers (HVs) with normal hepatic function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Child-Pugh A | Experimental | Participants with mild HI will receive a single dose of mavorixafor orally on an empty stomach, following a minimum 10-hour fasting period. |
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| Group 2: Child-Pugh B | Experimental | Participants with moderate HI will receive a single dose of mavorixafor orally on an empty stomach, following a minimum 10-hour fasting period. |
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| Group 3: Child-Pugh C | Experimental | Participants with severe HI will receive a single dose of mavorixafor orally on an empty stomach, following a minimum 10-hour fasting period. |
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| Group 4: HVs | Experimental | HVs matched with the mild HI participants will receive a single dose of mavorixafor orally on an empty stomach, following a minimum 10-hour fasting period. |
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| Group 5: HVs | Experimental | HVs matched with the moderate HI participants will receive a single dose of mavorixafor orally on an empty stomach, following a minimum 10-hour fasting period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mavorixafor | Drug | Mavorixafor will be administered per schedule specified in the arm description. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Mavorixafor | Predose up to 192 hours postdose (Day 1 up to Day 9) | |
| Area Under the Serum Concentration Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of Mavorixafor | Predose up to 192 hours postdose (Day 1 up to Day 9) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Day 1 up to Day 15 | |
| Time to Reach Cmax (Tmax) of Mavorixafor | Predose up to 192 hours postdose (Day 1 up to Day 9) |
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Key Inclusion Criteria:
Inclusion criteria applicable to participants with HI Only:
Key Exclusion Criteria:
Additional exclusion criteria applicable to Volunteers with Normal Hepatic Function Only:
Additional exclusion criteria applicable to participants with HI Only:
NOTE: Other protocol-defined inclusion and exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| X4 Pharmaceuticals, Inc. | Contact | 857-529-5779 | clinicaltrialinfo@x4pharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | X4 Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catalina Research Institute, LLC | Not yet recruiting | Montclair | California | 91763 | United States | |
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| Group 6: HVs | Experimental | HVs matched with the severe HI participants will receive a single dose of mavorixafor orally on an empty stomach, following a minimum 10-hour fasting period. |
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| Catalina Research Institute, LLC |
| Recruiting |
| Rialto |
| California |
| 91763 |
| United States |
| Orlando Clinical Research Center | Not yet recruiting | Orlando | Florida | 32809 | United States |
| Texas Liver Institute/Alamo Medical Research | Recruiting | San Antonio | Texas | 78215 | United States |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C494414 | mavorixafor |
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