LYT-300 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: LYT-300; Other: Placebo

• Registration Number: NCT05129865
• Lead Sponsor: PureTech

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2021-10-31
• Study First Submitted QC: 2021-11-11
• Study First Posted: 2021-11-22
• Study Start: 2021-12-07
• Status Verified: 2022-11
• Primary Completion: 2023-10-18
• Study Completion: 2023-10-23
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LYT-300 in healthy volunteers LYT-300, Doses TBD	Placebo	Subjects will crossover across 3 dosing periods in which they will receive placebo and two experimental dose levels
LYT-300 in healthy volunteers LYT-300	LYT-300	LYT-300, Dose TBD with and without food, separated by 7-day washout
Placebo QAM every 24 h for 7 days	Placebo	-
Placebo QHS every 24 h for 7 days	Placebo	-
LYT-300 in healthy volunteers LYT-300, Dose TBD QHS every 24 h for 7 days	LYT-300	-
LYT-300 in healthy volunteers LYT-300, Dose TBD QHS every 24 h for 7 days	Placebo	-
Placebo	Placebo	-
LYT-300 in healthy volunteers LYT-300, Doses TBD	LYT-300	Subjects will crossover across 3 dosing periods in which they will receive placebo and two experimental dose levels
LYT-300, Dose TBD QAM every 24 h for 7 days	LYT-300	-
Placebo QHS every 24 h for 7 days	LYT-300	-
LYT-300	LYT-300	-

Primary Outcome Measures

Name	Time	Method
Effect of food in healthy volunteers	2 days (main time frame)	Measure concentration of allopregnanolone in blood plasma in fed or fasted subjects administered a single dose of LYT-300
Safety and tolerability: treatment-emergent adverse events [TEAEs]	7 days (main time frame)	Evaluate the safety and tolerability in healthy volunteers following single or multiple oral doses of LYT-300 as measured by TEAEs.
Salivary cortisol	60 minutes	Change in salivary cortisol

Secondary Outcome Measures

Name	Time	Method
Use pharmacokinetics to characterize the blood plasma concentration of allopregnanolone after administration of LYT-300	7 days (main time frame)	Measure the blood plasma concentrations of allopregnanolone in healthy volunteers after single and multiple doses of LYT-300 administered up to 7 days

Trial Locations

Locations (1)

CMAX; 🇦🇺 Adelaide, South Australia, Australia