LYT-300 in Healthy Volunteers

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: LYT-300; Other: Placebo

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).

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Heather Paden; Phone Number: 617-456-0367; Email: clinicaltrials@puretechhealth.com
• Study Contact Backup: Name: Dan Bonner; Phone Number: 617-456-0367; Email: clinicaltrials@puretechhealth.com

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Recruiting
      • CMAX
      • Contact: Michele De Sciscio, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Main Inclusion Criteria:

Parts 1, 2 and 3: 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 and 3: 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / 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
Placebo Comparator: Placebo QHS every 24 h for 7 days	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, Dose TBD QHS every 24 h for 7 days	Drug: LYT-300; A prodrug of allopregnanolone, a small molecule drug; Other: Placebo; Placebo for LYT-300

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: PureTech
• Collaborators: Novotech (Australia) Pty Limited

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: October 31, 2021
• First Submitted That Met QC Criteria: November 11, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: LYT-300-2021-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No