LYT-300 in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Double Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of LYT-300 in Healthy Volunteers, and a Phase 1b/2a Study Part to Assess Effects of a Single Dose of LYT-300 vs. Placebo on the Response to a Standardized Behavioural Challenge in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05129865
• Other study ID #: LYT-300-2021-101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 7, 2021
• Est. completion date: October 23, 2023

Study information

• Verified date: November 2022
• Source: PureTech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: October 23, 2023
• Est. primary completion date: October 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• LYT-300
A prodrug of allopregnanolone, a small molecule drug

Other:
• Placebo
Placebo for LYT-300

Locations

Country	Name	City	State
Australia	CMAX	Adelaide	South Australia

Sponsors (2)

Lead Sponsor	Collaborator
PureTech	Novotech (Australia) Pty Limited

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days (main time frame)
Primary	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	2 days (main time frame)
Primary	Salivary cortisol	Change in salivary cortisol	60 minutes
Secondary	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	7 days (main time frame)