Pain ManagementPhase 1NCT07341152

A Study Comparing LTG-001 SDD Formulation To LTG-001 Crystalline Immediate Release Tablets In Healthy Participants

A Phase 1 study testing LTG-001 SDD, LTG-001 Formulation A Prototype 1 and LTG-001 Formulation B Prototype 2 in people with Pain Management, run by Latigo Biotherapeutics at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a single-center, open-label, part-randomized, crossover study in 14 healthy participants to assess the PK and safety profile of an SDD formulation of LTG-001 and two crystalline LTG-001 Instant Release tablet formulations, one of which will also be assessed at a differing dose level. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Pain Management
What is being tested?: LTG-001 SDD, LTG-001 Formulation A Prototype 1 and LTG-001 Formulation B Prototype 2
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 6 Oct 2025to 17 Nov 2025
Phase: Phase 1
Are there results?: None posted in the registry

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

Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures.
Must be willing and able to comply with all study requirements Aged 18 to 55 years inclusive at the time of signing informed consent.
Must agree to use an adequate method of contraception (as defined in Section 9.4.
Healthy males or non-pregnant, non-lactating, healthy females.
Body mass index of 18.0 to 32.0 kg/m2 as measured at screening.
Weight ≥50 kg at screening.

Who cannot join

Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients.
Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active.
Significant serious skin disease, including rash, food allergy, eczema, psoriasis, or urticaria.
History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease (except cholecystectomy), neurological or psychiatric disorder, as judged by the investigator.
Have poor venous access that limits phlebotomy.
Clinically significant abnormal clinical chemistry, hematology or urinalysis as judged by the investigator (laboratory parameters are listed in Appendix 1). Participants with Gilbert's Syndrome are allowed.

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Has ALT or AST >1.5 × ULN; Total bilirubin >1.5 × ULN (for participants with known Gilbert's syndrome these criteria only apply if the total bilirubin >1.5 × ULN as long as direct bilirubin is ≤1.5 × ULN) at screening.
Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <90 mL/min using the Cockcroft-Gault equation
Positive HBsAg, HCV Ab or HIV antibody results at screening.
Positive serum pregnancy test at screening or positive urine pregnancy test at first
Participants who have received any IMP in a clinical research study within 5 half-lives or within 30 days prior to first dose. However, in no event shall the time between last receipt of IMP and first dose be less than 30 days.
Participants who report to have previously received LTG-001. admission. Those who are pregnant or lactating will be excluded.
Personal or family history of long QT syndrome or a QTcF interval > 450 msec for men or > 470 for women on screening or first admission ECG. Participants who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g per day acetaminophen, HRT or oral contraception) in the 14 days before IMP administration (see Section 11.4). Exceptions may apply on a case-by-case basis, if considered not to interfere with the objectives of the study, as determined by the investigator.
Participants who have had any vaccine within 15 days before first IMP administration History of any drug or alcohol abuse in the past 2 years.
Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = 12 oz 1 bottle/can of beer, 1 oz 40% spirit, or 5 oz glass of wine).
A confirmed positive alcohol urine test at screening or first admission.
Current smokers and those who have smoked within the last 12 months.
Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months.
A confirmed positive urine cotinine test at screening or first admission.
Positive drug screen test result at screening or first admission (drug of abuse tests are listed in Appendix 1) Donation of blood within 2 months or donation of plasma within 7 days prior to first dose of study medication.
Participants who are, or are immediate family members of, a study site or sponsor employee.
Failure to satisfy the investigator of fitness to participate for any other reason.

Trial locations and contacts

1 site in 1 country.

United States1 site

Quotient Sciences - Miami, Inc
Miami, Florida, 33126

Other trials in United States

About this study

Official title: A Study to Assess the Pharmacokinetics and Relative Bioavailability of Crystalline LTG-001 Immediate Release Tablets Compared to LTG-001 SDD Formulation in Healthy Participants

Conditions: Pain Management
Being tested: LTG-001 SDD, LTG-001 Formulation A Prototype 1, LTG-001 Formulation B Prototype 2
Medical subject headings: Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LTG-001 SDDDrug
LTG-001
LTG-001 Formulation A Prototype 1Drug
LTG-001
LTG-001 Formulation B Prototype 2Drug
LTG-001
LTG-001 Formulation B prototype 2Drug
LTG-001 High Dose

Study groups in NCT07341152
Study group	Role	What they receive
Period 1 Regimen A SDD Tablet	Experimental	Not described Receives: Drug: LTG-001 SDD
Period 2 Regimen B	Experimental	Not described Receives: Drug: LTG-001 Formulation A Prototype 1
Period 3 Regimen C	Experimental	Not described Receives: Drug: LTG-001 Formulation B Prototype 2
Period 4 Regimen D	Experimental	Not described Receives: Drug: LTG-001 Formulation B prototype 2

What is being measured

The primary outcome is the main question the study is designed to answer.

Determine the relative bioavailability of two different LTG-001 crystalline formulations (test) compared to the LTG-001 SDD formulation (reference) in the fasted state.
results of LTG001 peak plasma concentration (Cmax)
Measured: From enrollment to Period 4, Day 3 Discharge
Determine the relative bioavailability of two different LTG-001 crystalline formulations (test) compared to the LTG-001 SDD formulation (reference) in the fasted state
Results of LTG001 Area under the plasma concentration versus time curve, (AUC (0-last))
Measured: from enrollment to Period 4, Day 3 discharge
Determine the relative bioavailability of two different LTG-001 crystalline formulations (test) compared to the LTG-001 SDD formulation (reference) in the fasted state.
Results of LTG001 Area under the plasma concentration versus time curve, (AUC (0-inf))
Measured: from enrollment to Period 4, Day 3 discharge
To characterize the PK of LTG-001 and metabolites LTGO-4247 and LTGO-4449, following single administrations of up to two dose levels of two different LTG-001 IR tablet formulations in the fasted state.
Results of Cmax
Measured: From Enrollment to Period 4, Day 3 discharge
To characterize the PK of LTG-001 and metabolites LTGO-4247 and LTGO-4449, following single administrations of up to two dose levels of two different LTG-001 IR tablet formulations in the fasted state
Results of Tmax
Measured: From enrollment to period 4, Day 3 Discharge
To characterize the PK of LTG-001 and metabolites LTGO-4247 and LTGO-4449, following single administrations of up to two dose levels of two different LTG-001 IR tablet formulations in the fasted state.
Results of AUC(0-last)
Measured: enrollment to Period 4, Day 3 discharge
To characterize the PK of LTG-001 and metabolites LTGO-4247 and LTGO-4449, following single administrations of up to two dose levels of two different LTG-001 IR tablet formulations in the fasted state.
Results of AUC (0-inf)
Measured: from enrollment to Period 4, Day 3 discharge
To characterize the PK of LTG-001 and metabolites LTGO-4247 and LTGO-4449, following single administrations of up to two dose levels of two different LTG-001 IR tablet formulations in the fasted state.
Results of T1/2
Measured: from enrollment to Period 4, Day 3 discharge

Secondary outcomes (1)

Secondary Objective
To assess safety and tolerability of single doses of LTG-001 when administered as IR formulations by evaluating number of participants with adverse events and SAEs, with abnormal laboratory tests results, abnormal 12-lead ECG readings, abnormal vital sign measurements and abnormal physical examination findings
Measured: from enrollment to Follow up phone call

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Oct 202517 Nov 2025

First posted14 Jan 2026
Study start6 Oct 2025
Primary completion17 Nov 2025
Study completion17 Nov 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pain ManagementStudies 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: Crossover
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07341152
Sponsor's protocol ID: LTG-001-011
Status last verified: Dec 2025
First submitted: 2 Dec 2025
Last updated: 14 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Assess the Pharmacokinetics and Relative Bioavailability of Crystalline LTG-001 Immediate Release Tablets Compared to LTG-001 SDD Formulation in Healthy Participants
ClinicalTrials.gov ID: NCT07341152
Acronym / sponsor ID: LTG-001-011
Conditions: Pain Management
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Latigo BiotherapeuticsIndustry (pharma, biotech, devices)
Study start: 6 Oct 2025 (actual)
Primary completion: 17 Nov 2025 (actual)
Study completion: 17 Nov 2025 (actual)
First posted: 14 Jan 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Period 1 Regimen A SDD Tablet	Experimental	Drug: LTG-001 SDD
Period 2 Regimen B	Experimental	Drug: LTG-001 Formulation A Prototype 1
Period 3 Regimen C	Experimental	Drug: LTG-001 Formulation B Prototype 2
Period 4 Regimen D	Experimental	Drug: LTG-001 Formulation B prototype 2

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures.
Must be willing and able to comply with all study requirements Aged 18 to 55 years inclusive at the time of signing informed consent.
Must agree to use an adequate method of contraception (as defined in Section 9.4.
Healthy males or non-pregnant, non-lactating, healthy females.
Body mass index of 18.0 to 32.0 kg/m2 as measured at screening.

Key exclusion criteria (22 listed)

Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients.
Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active.
Significant serious skin disease, including rash, food allergy, eczema, psoriasis, or urticaria.
History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease (except cholecystectomy), neurological or psychiatric disorder, as judged by the investigator.
Have poor venous access that limits phlebotomy.

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-001 SDDLTG-001	Drug	Period 1 Regimen A SDD Tablet
LTG-001 Formulation A Prototype 1LTG-001	Drug	Period 2 Regimen B
LTG-001 Formulation B Prototype 2LTG-001	Drug	Period 3 Regimen C
LTG-001 Formulation B prototype 2LTG-001 High Dose	Drug	Period 4 Regimen D

Primary outcome

Determine the relative bioavailability of two different LTG-001 crystalline formulations (test) compared to the LTG-001 SDD formulation (reference) in the fasted state.
Time frame: From enrollment to Period 4, Day 3 Discharge
results of LTG001 peak plasma concentration (Cmax)
Determine the relative bioavailability of two different LTG-001 crystalline formulations (test) compared to the LTG-001 SDD formulation (reference) in the fasted state
Time frame: from enrollment to Period 4, Day 3 discharge
Results of LTG001 Area under the plasma concentration versus time curve, (AUC (0-last))
Determine the relative bioavailability of two different LTG-001 crystalline formulations (test) compared to the LTG-001 SDD formulation (reference) in the fasted state.
Time frame: from enrollment to Period 4, Day 3 discharge
Results of LTG001 Area under the plasma concentration versus time curve, (AUC (0-inf))
To characterize the PK of LTG-001 and metabolites LTGO-4247 and LTGO-4449, following single administrations of up to two dose levels of two different LTG-001 IR tablet formulations in the fasted state.
Time frame: From Enrollment to Period 4, Day 3 discharge
Results of Cmax
To characterize the PK of LTG-001 and metabolites LTGO-4247 and LTGO-4449, following single administrations of up to two dose levels of two different LTG-001 IR tablet formulations in the fasted state
Time frame: From enrollment to period 4, Day 3 Discharge
Results of Tmax
To characterize the PK of LTG-001 and metabolites LTGO-4247 and LTGO-4449, following single administrations of up to two dose levels of two different LTG-001 IR tablet formulations in the fasted state.
Time frame: enrollment to Period 4, Day 3 discharge
Results of AUC(0-last)
To characterize the PK of LTG-001 and metabolites LTGO-4247 and LTGO-4449, following single administrations of up to two dose levels of two different LTG-001 IR tablet formulations in the fasted state.
Time frame: from enrollment to Period 4, Day 3 discharge
Results of AUC (0-inf)
To characterize the PK of LTG-001 and metabolites LTGO-4247 and LTGO-4449, following single administrations of up to two dose levels of two different LTG-001 IR tablet formulations in the fasted state.
Time frame: from enrollment to Period 4, Day 3 discharge
Results of T1/2

1 secondary outcome

Secondary Objective
Time frame: from enrollment to Follow up phone call

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
Individual participant dataSharing planned: No

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RecruitingPhase 3
Influence of Superficial Parasternal Intercostal Plane Block on Internal Thoracic Artery Caliber to Facilitate Surgical Harvesting in CABG
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Active, not recruitingPhase 2
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The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LTG-001 SDD, LTG-001 Formulation A Prototype 1 and LTG-001 Formulation B Prototype 2 in people with Pain Management, run by Latigo Biotherapeutics at 1 site in United States.

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 6 inclusion and 22 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: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Determine the relative bioavailability of two different LTG-001 crystalline formulations (test) compared to the LTG-001 SDD formulation (reference) in the fasted state. (time frame: From enrollment to Period 4, Day 3 Discharge). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07341152.

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 14 Jan 2026; AzTrials last refreshed its copy on 29 Oct 2026.