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

Latigo Biotherapeutics

Status and phase: Completed; Phase 1

Conditions: Pain Management

Treatments: 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

Funder types: Industry

Identifiers

NCT07341152

LTG-001-011

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

14 participants in 4 patient groups

Period 1 Regimen A SDD Tablet

Experimental group

Treatment:

Drug: LTG-001 SDD

Period 2 Regimen B

Experimental group

Treatment:

Drug: LTG-001 Formulation A Prototype 1

Period 3 Regimen C

Experimental group

Treatment:

Drug: LTG-001 Formulation B Prototype 2

Period 4 Regimen D

Experimental group

Treatment:

Drug: LTG-001 Formulation B prototype 2