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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
38
Mavorixafor will be administered per schedule specified in the arm description.
Carbamazepine will be administered per schedule specified in the arm description.
Efavirenz will be administered per schedule specified in the arm description.
Parexel International LLC
Baltimore, Maryland, United States
Cohort 1: Maximum Observed Plasma Concentration (Cmax) of Mavorixafor Without (Day 1) and With (Day 18) Coadministration With Carbamazepine
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Predose up to 120 hours postdose on Days 1 and 18
Cohort 1: Time to Reach Cmax (Tmax) of Mavorixafor Without (Day 1) and With (Day 18) Coadministration With Carbamazepine
Time frame: 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
Time frame: Predose up to 120 hours postdose on Days 1 and 18
Cohort 1: Predose Concentration (Ctrough) of Carbamazepine
Time frame: Predose on Days 14, 16, and 18
Cohort 2: Ctrough of Efavirenz
Time frame: Predose on Days 14, 16, and 18
Cohorts 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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Time frame: Day 1 up to Day 33