LYT-300 in Healthy Volunteers

PureTech186 enrolled

Overview

Part 1 is a single ascending dose (SAD) trial in healthy volunteers (HV) to assess the safety, tolerability, and pharmacokinetic (PK) profile of orally administered LYT-300. Part 2 is a crossover assessment in HV of the effects of food on the safety, tolerability, and PK profile of orally administered LYT-300. Part 3 is a multiple ascending dose (MAD) trial in HV to assess the safety, tolerability, and PK profile of multiple doses (up to 7 days) of orally administered LYT-300. Part 4 is an assessment of the effects of LYT-300 vs. placebo on pharmacodynamic and patient reported outcome response to a validated clinical model of anxiety.

Part 1: This is a randomized, double-blind, placebo-controlled, SAD design to assess the safety, tolerability, and PK profile of orally administered LYT-300 in HV, in a 3-period, 3-sequence, crossover, dose escalation design. Part 2: This is a randomized, open label, 3-period, 3-sequence, crossover assessment of the effects of food on the PK, safety, and tolerability of orally administered LYT-300 in HV. A single dose of LYT-300 will be administered on 3 occasions, separated by a minimum 7-day washout period. Part 2 is planned as a single dosing cohort. Part 3: This is a randomized, double-blind, placebo-controlled, sequential, MAD trial in HV to assess the safety, tolerability, and PK profile of multiple doses (up to 7 days) of orally administered LYT-300. This part will include ascending doses given either once daily in the morning (QAM), once daily in the evening (QHS), or twice daily (BID). Part 4: This is a double-blind, randomized assessment of the effects in HV of a single dose of LYT-300 vs. placebo on pharmacodynamic and patient reported outcome response to a validated clinical model of anxiety.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

186

Conditions

Healthy Volunteers

Interventions

LYT-300DRUG

A prodrug of allopregnanolone, a small molecule drug

PlaceboOTHER

Placebo for LYT-300

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Main Inclusion Criteria: Parts 1, 2, 3 and 4: Healthy Volunteers 1. Male or female between 18 and 55 years old (inclusive) at the time of screening. 2. In good general health at screening, free from clinically significant unstable medical, surgical or psychiatric illness, at the discretion of the Investigator. Main Exclusion Criteria: Parts 1, 2, 3 and 4: Healthy Volunteers 1. Evidence or history of any condition or situation that adversely impacts a normal sleep-wake cycle. 2. Confirmed COVID-19 infection within 2 months of screening, known exposure to another person with COVID-19 within 14 days of screening 3. History of illness with fever within 28 days prior to the first dose. 4. A history of, or current evidence for, serious mental illness

Locations (1)

CMAX

Adelaide, South Australia, Australia

Outcomes

Primary Outcomes

Safety and tolerability: treatment-emergent adverse events [TEAEs]

Evaluate the safety and tolerability in healthy volunteers following single or multiple oral doses of LYT-300 as measured by TEAEs.

Time frame: 7 days (main time frame)

Effect of food in healthy volunteers

Measure concentration of allopregnanolone in blood plasma in fed or fasted subjects administered a single dose of LYT-300

Time frame: 2 days (main time frame)

Salivary cortisol

Change in salivary cortisol

Time frame: 60 minutes

Secondary Outcomes

Use pharmacokinetics to characterize the blood plasma concentration of allopregnanolone after administration of LYT-300

Measure the blood plasma concentrations of allopregnanolone in healthy volunteers after single and multiple doses of LYT-300 administered up to 7 days

Time frame: 7 days (main time frame)

Data from ClinicalTrials.gov

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