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The main purpose of this study is to evaluate drug-drug interaction (DDI) of orally administered mavorixafor with cytochrome P3A (CYP3A) inducers carbamazepine (a strong CYP3A inducer) or efavirenz (a moderate CYP3A inducer) in healthy male and female participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Mavorixafor and Carbamazepine | Experimental | Participants will receive a single dose of mavorixafor administered on Day 1 and a single dose of mavorixafor administered on Day 18 on an empty stomach, after an overnight fast (at least 10 hours). Participants will receive carbamazepine administered orally twice daily (BID) on Days 6 through Day 22, 30 minutes after the end of a meal. |
|
| Cohort 2: Mavorixafor and Efavirenz | Experimental | Participants will receive a single dose of mavorixafor administered on Day 1 and a single dose of mavorixafor administered on Day 18 on an empty stomach, after an overnight fast (at least 10 hours). Participants will receive efavirenz administered once daily (QD) on Days 6 through 22, at bedtime, at least 4 hours after the end of a meal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mavorixafor | Drug | Mavorixafor will be administered per schedule specified in the arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: Maximum Observed Plasma Concentration (Cmax) of Mavorixafor Without (Day 1) and With (Day 18) Coadministration With Carbamazepine | Predose up to 120 hours postdose on Days 1 and 18 | |
| Cohort 1: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Mavorixafor Without (Day 1) and With (Day 18) Coadministration With Carbamazepine | Predose up to 120 hours postdose on Days 1 and 18 | |
| Cohort 2: Cmax of Mavorixafor Without (Day 1) and With (Day 18) Coadministration With Efavirenz | Predose up to 120 hours postdose on Days 1 and 18 | |
| Cohort 2: AUC0-last of Mavorixafor Without (Day 1) and With (Day 18) Coadministration With Efavirenz | Predose up to 120 hours postdose on Days 1 and 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: Time to Reach Cmax (Tmax) of Mavorixafor Without (Day 1) and With (Day 18) Coadministration With Carbamazepine | Predose up to 120 hours postdose on Days 1 and 18 | |
| Cohort 2: Tmax Mavorixafor Without (Day 1) and With (Day 18) Coadministration With Efavirenz |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Specific exclusion criteria for Cohort 1:
Specific exclusion criteria for Cohort 2:
NOTE: Other protocol-defined inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | X4 Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International LLC | Baltimore | Maryland | 21225 | United States |
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| ID | Term |
|---|---|
| C494414 | mavorixafor |
| D002220 | Carbamazepine |
| C098320 | efavirenz |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Carbamazepine | Drug | Carbamazepine will be administered per schedule specified in the arm description. |
|
| Efavirenz | Drug | Efavirenz will be administered per schedule specified in the arm description. |
|
| Predose up to 120 hours postdose on Days 1 and 18 |
| Cohort 1: Predose Concentration (Ctrough) of Carbamazepine | Predose on Days 14, 16, and 18 |
| Cohort 2: Ctrough of Efavirenz | Predose on Days 14, 16, and 18 |
| Cohorts 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Day 1 up to Day 33 |