Phase 1 Single and Multiple Ascending Dose of LTG-321 in Healthy Participants

Phase

Condition

N/A

Treatment

LTG-321

Placebo

Clinical Study ID

NCT07110610

LTG-321-013

Ages 18-55
All Genders
Accepts Healthy Volunteers

Study Summary

This is a first-in-human, randomized, double-blind, placebo-controlled Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered LTG-321 in healthy male and female participants 18 to 55 years of age. The study will be conducted in New Zealand.

The study also includes a randomized, double-blind, placebo-controlled, within-participant crossover evaluation of pain tolerance using a cold pressor test in healthy male participants 18 to 55 years of age. In addition, a randomized, open-label, crossover Food Effect cohort will evaluate the impact of a high-fat meal on the pharmacokinetics of LTG-321 following single oral doses in the fed and fasted state.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Male and female participants aged 18 to 55 years, inclusive, at the time of signingthe informed consent.
Overtly healthy with no clinically relevant abnormalities based on the medicalhistory, physical examinations, clinical laboratory evaluations, and 12-lead ECGthat, in the opinion of the investigator, would affect participant safety.
Body mass index (BMI) within the range of 18-30 kg/m2 (inclusive).

Exclusion

Exclusion Criteria:

Inability to take oral medications or gastrointestinal abnormalities potentiallyimpacting absorption.
Clinically significant cardiovascular, hematological, renal, hepatic, pulmonary,endocrine, gastrointestinal, immunological, dermatological, neurological, orpsychiatric disease which could interfere with, or the treatment for which mightinterfere with, the conduct of the study or which would, in the opinion of theinvestigator, unacceptably increase the participant's risk by participating in thestudy.
Past or current history or evidence of alcohol abuse and/or dependence onrecreational drug use
Donation of over 500 mL blood ≤ 3 months prior to start of participation
Participant is under legal custodianship.

Study Design