PK Drug-drug Interaction StudyPhase 1NCT07915947
LTG-321 - Itraconazole Drug-drug Interaction (DDI) Study
A Phase 1 study testing LTG-321 and Itraconazole (200 mg) in people with PK Drug-drug Interaction Study, run by Latigo Biotherapeutics.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- PK Drug-drug Interaction Study
- What is being tested?
- LTG-321 and Itraconazole (200 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 4 Dec 2026to 30 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- PK Drug-drug Interaction Study
- Being tested
- LTG-321, Itraconazole (200 mg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTG-321Drug
LTG-321 is a novel, orally bioavailable, small molecule NaV1.8 inhibitor being developed as a non-opioid analgesic product
Itraconazole (200 mg)Drug
Itraconazole is a known strong CYP3A inhibitor
| Study group | Role | What they receive |
|---|---|---|
| LTG-321 Alone | Experimental | Not described Receives: Drug: LTG-321 |
| LTG-321 Plus Itraconazole | Experimental | Not described Receives: Drug: LTG-321; Drug: Itraconazole (200 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of LTG-321 and Its Metabolite(s)
Area under the plasma concentration-time curve from dosing to the last measurable concentration, following LTG-321 administered alone or with itraconazole.
Measured: 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)
Maximum observed plasma concentration following LTG-321 administered alone or with itraconazole.
Measured: 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)
Terminal elimination half-life following LTG-321 administered alone or with itraconazole.
Measured: Pre-dose through 240 hours after LTG-321 administration on Day 1 for Group A and Day 5 for Group B.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start4 Dec 2026 (estimated)
- Primary completion24 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PK Drug-drug Interaction StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Latigo Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915947
- Sponsor's protocol ID
- LTG-321-026
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Evaluate the Effect of Strong CYP3A Inhibition on the Pharmacokinetics of LTG-321 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07915947
- Acronym / sponsor ID
- LTG-321-026
- Conditions
- PK Drug-drug Interaction Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Latigo BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2026 (estimated)
- Primary completion
- 24 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LTG-321 Alone | Experimental | Drug: LTG-321 |
| LTG-321 Plus Itraconazole | Experimental | Drug: LTG-321, Drug: Itraconazole (200 mg) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LTG-321LTG-321 is a novel, orally bioavailable, small molecule NaV1.8 inhibitor being developed as a non-opioid analgesic product | Drug | LTG-321 Alone, LTG-321 Plus Itraconazole |
| Itraconazole (200 mg)Itraconazole is a known strong CYP3A inhibitor | Drug | LTG-321 Plus Itraconazole |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LTG-321 and Itraconazole (200 mg) in people with PK Drug-drug Interaction Study, run by Latigo Biotherapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.