Healthy Participants
Conditions
Brief summary
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.
Interventions
DRUGMavorixafor
Mavorixafor will be administered per schedule specified in the arm description.
DRUGCarbamazepine
Carbamazepine will be administered per schedule specified in the arm description.
DRUGEfavirenz
Efavirenz will be administered per schedule specified in the arm description.
Sponsors
X4 Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Body mass index (BMI) between 18.5 and 32 kilograms (kg)/square meter (m\^2), inclusive, and body weight not less than 50 kg at Screening. * Nonsmokers (or other tobacco or nicotine-containing products, in any form, including e-cigarettes and vaping) as determined by history (no nicotine use for 6 months before Screening) and by negative cotinine test at Screening and Admission. * Healthy, determined by prestudy medical evaluation (medical history, physical examination, vital signs, 12-lead electrocardiogram \[ECG\], and clinical laboratory evaluations) at Screening and Admission. A repeat test (only once per visit) for vitals, ECG, and/or clinical laboratory evaluations may be performed at the investigator's discretion to confirm results. Key
Exclusion criteria
* Participant has used an investigational drug (including mavorixafor) within 30 days (90 days for biologics), or 5 half-lives, whichever is longer prior to Screening. * Participant has a history of or currently suffers from an active illness considered to be clinically significant (CS) by the investigator or any other illness that the investigator considers should exclude the participant from the study or that could interfere with the interpretation of the study results. * Participant has CS history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, metabolic, allergic, hematological, or psychiatric disorder(s) as determined by the investigator or designee. * Female participant is breastfeeding, pregnant, or plans to be pregnant within the duration of the study and up to 4 weeks after completion of the study. * Use any drugs of abuse (medical or recreational) for at least 30 days prior to first study intervention administration as documented by a history and positive results for urine drug screening (for example, cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids), at Screening and/or Admission. * Participant has positive coronavirus disease 2019 test on Admission confirmed by rapid antigen testing. * Receipt of any vaccine within 30 days prior to first study intervention or plans to receive any vaccination during the study. * Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment. Specific
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| Cohorts 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Day 1 up to Day 33 |
| Cohort 2: Tmax Mavorixafor Without (Day 1) and With (Day 18) Coadministration With Efavirenz | 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 |
Countries
United States
Outcome results
None listed