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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain Management
• Intervention / Treatment: Drug: LTG-001 SDD; Drug: LTG-001 Formulation A Prototype 1; Drug: LTG-001 Formulation B Prototype 2; Drug: LTG-001 Formulation B prototype 2

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33126
      • Quotient Sciences - Miami, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Period 1 Regimen A SDD Tablet	Drug: LTG-001 SDD; LTG-001
Experimental: Period 2 Regimen B	Drug: LTG-001 Formulation A Prototype 1; LTG-001
Experimental: Period 3 Regimen C	Drug: LTG-001 Formulation B Prototype 2; LTG-001
Experimental: Period 4 Regimen D	Drug: LTG-001 Formulation B prototype 2; LTG-001 High Dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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))	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))	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	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	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)	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)	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	from enrollment to Period 4, Day 3 discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	from enrollment to Follow up phone call

Collaborators and Investigators

• Sponsor: Latigo Biotherapeutics

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2025
• Primary Completion (Actual): November 17, 2025
• Study Completion (Actual): November 17, 2025

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia
• Other Study ID Numbers: LTG-001-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No