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Not Yet Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07915947). StuddyBuddy aggregates publicly available trial information.