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

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.