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

NCT07341152 | Completed Phase 1 FDA Drug

• 1 other identifier: LTG-001-011
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain Management

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Secondary Objective

  from enrollment to Follow up phone call

Study Arms (4)

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

Interventions

LTG-001 SDD DRUG

LTG-001

Period 1 Regimen A SDD Tablet

LTG-001 Formulation A Prototype 1 DRUG

LTG-001

Period 2 Regimen B

LTG-001 Formulation B prototype 2 DRUG

LTG-001

Period 3 Regimen C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Latigo Biotherapeutics: lead

Study Sites (1)

Quotient Sciences - Miami, Inc

Miami, Florida, 33126, United States

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 14, 2026
• Study Start: October 6, 2025
• Primary Completion: November 17, 2025
• Study Completion: November 17, 2025
• Last Updated: January 14, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)