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NCT07915947
LTG-321 - Itraconazole Drug-drug Interaction (DDI) Study
Conditions: PK Drug-drug Interaction Study
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 28
Sponsor: Latigo Biotherapeutics
Summary
This Phase 1, single-center, open-label, randomized, parallel-group study will evaluate the effect of itraconazole on the PK of LTG-321 and its metabolite(s), and the safety and tolerability of LTG-321 administered alone and in combination with itraconazole, in healthy participants.
Eligibility Criteria
Inclusion Criteria:
* Healthy adults aged 18-55 years, inclusive.
* Body mass index (BMI) of 18.0-28.0 kg/m², inclusive.
* Willing to meet applicable contraception and reproductive restrictions during the study and for 90 days after the last study drug dose.
* Able to provide written informed consent and comply with study visits, procedures, and restrictions
Exclusion Criteria:
* Clinically significant medical conditions or abnormalities on examination, laboratory testing, vital signs, or ECG that could affect participant safety or study results.
* Gastrointestinal conditions that could affect drug absorption, or a history of gallstones or gallbladder removal.
* Pregnancy or breastfeeding.
* Relevant drug allergies or contraindications to LTG-321, itraconazole, or their ingredients.
* Recent smoking, vaping, or nicotine use; relevant substance or alcohol dependence history; or positive substance screening outside protocol-permitted exceptions.
* Use of prohibited medications, supplements, or vaccinations within protocol-specified periods.
* Known or confirmed hepatitis B, hepatitis C, or HIV infection, subject to protocol-defined exceptions.
* Previous participation in an LTG-321 study, recent participation in another investigational study, or recent blood or plasma donation within prohibited periods.
Source: ClinicalTrials.gov (NCT07915947). StuddyBuddy aggregates publicly available trial information.