LYT-300 in Healthy Volunteers

Sponsor

PureTech (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05129865

Collaborator

Novotech (Australia) Pty Limited (Industry)

Enrollment

Location

Arms

15.8

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: LYT-300 Other: Placebo	Phase 1

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, 2-period, 2-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 2 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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Part 1 consists of 1 Arm with crossover of active treatment and placebo Part 2 consists of 1 Arm with active treatment Part 3 consists of 6 Arms with active treatment or placeboPart 1 consists of 1 Arm with crossover of active treatment and placebo Part 2 consists of 1 Arm with active treatment Part 3 consists of 6 Arms with active treatment or placebo

Masking:

Double (Participant, Investigator)

Masking Description:

Part 1 and Part 3 are double-blind during the data collection. Determination for dose escalation may be made under unblinded conditions by assessors. Part 2 is open-label.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 7, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LYT-300 in healthy volunteers LYT-300, Doses TBD Subjects will crossover across 3 dosing periods in which they will receive placebo and two experimental dose levels	Drug: LYT-300 A prodrug of allopregnanolone, a small molecule drug Other: Placebo Placebo for LYT-300
Experimental: LYT-300 in healthy volunteers LYT-300 LYT-300, Dose TBD with and without food, separated by 7-day washout	Drug: LYT-300 A prodrug of allopregnanolone, a small molecule drug
Experimental: LYT-300, Dose TBD QAM every 24 h for 7 days	Drug: LYT-300 A prodrug of allopregnanolone, a small molecule drug
Placebo Comparator: Placebo QAM every 24 h for 7 days	Other: Placebo Placebo for LYT-300
Experimental: LYT-300 in healthy volunteers LYT-300, Dose TBD QAM or QHS every 24 h for 7 days Subjects will crossover across 2 dosing periods in which they will receive LYT-300 Dose TBD QAM or QHS every 24 h for 7 days	Drug: LYT-300 A prodrug of allopregnanolone, a small molecule drug
Placebo Comparator: Placebo QAM or QHS every 24 h for 7 days Subjects will crossover across 2 dosing periods in which they will Placebo QAM or QHS every 24 h for 7 days	Other: Placebo Placebo for LYT-300
Experimental: LYT-300 in healthy volunteers LYT-300, Dose TBD BID every 12 h for 7 days	Drug: LYT-300 A prodrug of allopregnanolone, a small molecule drug
Placebo Comparator: Placebo BID every 12 h for 7 days	Other: Placebo Placebo for LYT-300

Outcome Measures

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Main Inclusion Criteria:

Parts 1, 2 and 3: Healthy Volunteers

Male or female between 18 and 55 years old (inclusive) at the time of screening.
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 and 3: Healthy Volunteers

Evidence or history of any condition or situation that adversely impacts a normal sleep-wake cycle.
Confirmed COVID-19 infection within 6 months of screening, known exposure to another person with COVID-19 within 14 days of screening
History of illness with fever within 28 days prior to the first dose.
A history of, or current evidence for, serious mental illness

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CMAX	Adelaide	South Australia	Australia	5000

Sponsors and Collaborators

PureTech
Novotech (Australia) Pty Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

PureTech

ClinicalTrials.gov Identifier:

NCT05129865

Other Study ID Numbers:

LYT-300-2021-101

First Posted:

Nov 22, 2021

Last Update Posted:

Jan 4, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 4, 2022