LTG-321 - Itraconazole Drug-drug Interaction (DDI) Study
A Phase 1, Open-Label Study to Evaluate the Effect of Strong CYP3A Inhibition on the Pharmacokinetics of LTG-321 in Healthy Participants
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: LTG-321 Alone
|
LTG-321 is a novel, orally bioavailable, small molecule NaV1.8 inhibitor being developed as a non-opioid analgesic product |
|
Experimental: LTG-321 Plus Itraconazole
|
LTG-321 is a novel, orally bioavailable, small molecule NaV1.8 inhibitor being developed as a non-opioid analgesic product Itraconazole is a known strong CYP3A inhibitor |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of LTG-321 and Its Metabolite(s)
Time Frame: Pre-dose through 240 hours after LTG-321 administration on Day 1 for Group A and Day 5 for Group B.
|
Area under the plasma concentration-time curve from dosing to the last measurable concentration, following LTG-321 administered alone or with itraconazole. |
Pre-dose through 240 hours after LTG-321 administration on Day 1 for Group A and Day 5 for Group B.
|
|
Maximum Observed Plasma Concentration (Cmax) of LTG-321 and Its Metabolite(s)
Time Frame: Pre-dose through 240 hours after LTG-321 administration on Day 1 for Group A and Day 5 for Group B.
|
Maximum observed plasma concentration following LTG-321 administered alone or with itraconazole. |
Pre-dose through 240 hours after LTG-321 administration on Day 1 for Group A and Day 5 for Group B.
|
|
Terminal Elimination Half-Life (T1/2) of LTG-321 and Its Metabolite(s)
Time Frame: Pre-dose through 240 hours after LTG-321 administration on Day 1 for Group A and Day 5 for Group B.
|
Terminal elimination half-life following LTG-321 administered alone or with itraconazole. |
Pre-dose through 240 hours after LTG-321 administration on Day 1 for Group A and Day 5 for Group B.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LTG-321-026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.