A Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally in Healthy Participants

Study Overview
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Brief Summary
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This is a sequential, randomized, double-blind, placebo-controlled Phase 1 single (SAD) and multiple (MAD) ascending dose study to evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered LTG-001 in healthy male and female participants

Official Title
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A Sequential, Randomized, Double-Blind, Placebo-Controlled, Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Male and Female Participants 18 to 55 Years of Age

Conditions
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Healthy

Intervention / Treatment
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* Drug: LTG-001
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female participants aged 18 to 55 years, inclusive, at the time of signing the informed consent. Overtly healthy with no clinically relevant abnormalities based on the medical history, physical examinations, clinical laboratory evaluations, and 12-lead ECG that, in the opinion of the investigator, would affect participant safety. Body mass index (BMI) within the range of 18-32 kg/m2 (inclusive). Exclusion Criteria: Inability to take oral medications or gastrointestinal abnormalities potentially impacting absorption Clinically significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the investigator, unacceptably increase the participant's risk by participating in the study Past or current history or evidence of alcohol abuse and/or dependence on recreational drug use Donation of over 500 mL blood ≤ 3 months prior to start of participation Has known psychiatric disorders that would interfere with the cooperation with the requirements of the study Participant is under legal custodianship.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LTG-001<br>Part A: Single-Ascending dose cohorts; relative bioavailability; food effect; Part B: Multiple-ascending dose cohorts | Drug: LTG-001<br>* Oral doses<br>|
| Placebo Comparator: Placebo<br>Part A: Single-Ascending dose cohorts; Part B: Multiple-ascending dose cohorts | Drug: Placebo<br>* Oral doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety and tolerability of single and multiple ascending oral doses, relative bioavailability and food effect of LTG-001 in healthy subjects | Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs) | Up to 10 days of dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To further characterize the PK of LTG-001 in healthy participants | Cmax | Up to 10 days of dosing | 
| To further characterize the PK of LTG-001 in healthy participants | Area under the concentration curve from 0 to last (AUC0-last) | Up to 10 days of dosing | 
| To further characterize the PK of LTG-001 in healthy participants | Area under the concentration curve from 0 to infinity (AUC0-inf) | Up to 10 days of dosing | 
| To further characterize the PK of LTG-001 in healthy participants | Time of the maximum observed plasma concentration (tmax) | Up to 10 days of dosing | 
| To further characterize the PK of LTG-001 in healthy participants | Elimination rate constant (λz) | Up to 10 days of dosing | 
| To further characterize the PK of LTG-001 in healthy participants | Terminal elimination half-life (t1⁄2) | Up to 10 days of dosing | 
| To further characterize the PK of LTG-001 in healthy participants | Concentration at 12 hours (C12) | Up to 10 days of dosing | 
| To further characterize the PK of LTG-001 in healthy participants | Oral clearance (CL/F) | Up to 10 days of dosing | 
| To further characterize the PK of LTG-001 in healthy participants | Oral apparent volume of distribution (Vz/F) | Up to 10 days of dosing |